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Kamada Ltd.$5.92($.03)(.50%)

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 Kamada Reports Financial Results for Third Quarter and First Nine Months of 2017
   Monday, November 13, 2017 6:30:24 AM ET

Total Revenues for Third Quarter were $22.9 million, an 18% Increase

Total revenues for first 9 months of 2017 were $67.1 million, a 26% Increase

On Track to Achieve $100 Million in Total Revenues in 2017

Guiding to $116 to $120 Million in Total Revenues in 2018

Conference Call Today at 8:30 AM ET

Kamada Ltd. (KMDA ) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced financial results for the three and nine months ended September 30, 2017.

"We had a very solid third quarter on all fronts," said Amir London, Kamada’s Chief Executive Officer. "Total quarterly revenues of $23 million represented a year-over-year increase of 18%, and contributed to revenues for the first nine months of 2017 of $67 million, which was an increase of 26% over the first nine months of 2016. Our revenue growth continues to be driven by the higher Glassia(R) sales in the US. From a profitability standpoint, we generated positive operating and net income over the first nine months of the year. Following our strong performance through the first nine months of 2017, we remain confident in our ability to attain our previously stated guidance of reaching $100 million in total revenue in 2017.

"We were also pleased to have received the U.S. Food and Drug Administration approval in the third quarter for our Anti-Rabies IgG, KEDRAB(TM), and look forward to launching this product in the U.S. in collaboration with Kedrion, our strategic partner, early in 2018. With the continued growth of sales of Glassia in the U.S. and our planned launch of KedRAB, we are expecting total revenues in 2018 to be in the range of $116 to $120 million, or 16%-20% revenue growth for 2018 compared to 2017’s anticipated revenues. Moreover, following our $15.6 million equity offering, which closed in the third quarter, we are in an extremely strong financial position as we head into 2018," continued Mr. London.

"Looking ahead, we have multiple expected upcoming clinical milestones, including finalization of our discussions with the FDA on our proprietary inhaled Alpha-1 Antitrypsin (AAT) for the treatment of AAT Deficiency and upon approval, the initiation of a U.S. Phase 3 pivotal clinical trial, expected in the second half of 2018. We are also looking forward to making progress in the Company’s clinical program for our AAT-IV for the treatment of acute Graft-Versus-Host Disease (GvHD), and determining the appropriate next steps forward in our clinical program for the treatment of newly diagnosed Type-1 Diabetes patients based on the recently announced Phase 2 results. Finally, we also expect the availability of the interim report from our ongoing Phase 2 trial with IV AAT for lung transplantation before year-end 2017," added Mr. London.

Financial Highlights for the Three Months Ended September 30, 2017

-- Total revenues were $22.9 million, an 18% increase from the $19.4 million reported in the third quarter of 2016.

-- Revenues from the Proprietary Products segment were $17.1 million, a 13% increase from the $15.0 million reported in the third quarter of 2016.

-- Revenues from the Distributed Products segment were $5.9 million, a 35% increase from the $4.3 million reported in the third quarter of 2016.

-- Gross profit was $6.4 million, a 3% increase from the $6.3 million reported in the third quarter of 2016.

-- Gross margin decreased to 28% from 32% in the third quarter of 2016.

-- Net loss was $0.2 million, or $0.01 per share, compared to a net loss of $1.0 million, or a loss of $0.03 per share, in the third quarter of 2016.

-- Adjusted net income was less than $0.1 million compared to adjusted net loss of $0.7 million in the third quarter of 2016.

Financial Highlights for the Nine Months Ended June 30, 2017

-- Total revenues were $67.1 million, a 26% increase from $53.2 million in the nine months ended September 30, 2016.

-- Revenues from the Proprietary Products segment were $50.6 million, a 32% increase from $38.3 million reported in the same period of 2016.

-- Revenues from the Distributed Products segment were $16.5 million, an 11% increase from the $15.0 million reported in the same period of 2016.

-- Gross profit was $20.5 million, a 23% increase from the $16.7 million reported in the same period of 2016.

-- Gross margin decreased to 30% from 31% in the same period of 2016.

-- Net income was $0.6 million, or $0.02 per share, compared to a net loss of $4.9 million, or a loss of $0.14 per share, in the same period of 2016.

-- Adjusted net income was $1.3 million compared to an adjusted net loss of $3.9 million in the same period of 2016, an improvement of $5.2 million year-over-year.

Recent Corporate Highlights:

-- Received U.S. Food and Drug Administration (FDA) approval for KEDRAB(TM) [rabies immune globulin (Human)] for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year, representing an annual market opportunity of $100 million-plus. KEDRAB will launch in the U.S. in early 2018.

-- Announced top-line results from Phase 2 trial of AAT in newly diagnosed type-1 diabetes, or T1D, patients. While no significant treatment effect was observed in the overall study population, in the pre-determined subgroup of patients between the ages of 12 and 18 years old, a trend toward better efficacy was demonstrated in the high-dose arm of AAT. Based on the top-line results of this study, Kamada, and its external TID key opinion leaders, believe that further studies in a larger population are warranted. Once the full data from this study are available, the Company will evaluate the collective results in order to determine the appropriate next steps forward.

-- Submitted to the FDA for review a proposed pivotal Phase 3 protocol for Kamada’s inhaled Alpha-1 Antitrypsin (AAT) therapy (Inhaled AAT) for the treatment of AATD. Kamada expects a response from the FDA in regards to the proposed protocol and will submit additional data at the beginning of 2018. If approved by the FDA, the Company intends to proceed with a U.S. Phase 3 pivotal clinical trial in the second half of 2018.

-- Closed an underwritten public offering for net proceeds of $15.6 million to be used to fund clinical development programs.

-- Announced a collaboration for advanced research on AAT with a focus on mechanism of action with BGN Technologies, the business arm of Ben Gurion University (BGU). Professor Eli Lewis, Department of Clinical Biochemistry and Pharmacology at BGU, and one of the world’s foremost AAT investigators, will lead the collaboration. The planned research studies will serve as a scientifically and regulatory well-founded background to compare recombinant human AAT products that are developed as part of Kamada’s potential future pipeline.

Third Quarter 2017 Financial Results Compared to Third Quarter 2016 Financial Results

Total revenues for the third quarter of 2017 were $22.9 million, an 18% increase from the $19.4 million reported in the third quarter of 2016. Revenues from the Proprietary Products segment were $17.1 million, a 13% increase from the $15.0 million reported in the third quarter of 2016. Revenues from the Distributed Products segment were $5.9 million, a 35% increase from the $4.3 million reported in the third quarter of 2016.

Gross profit for the third quarter of 2017 was $6.4 million, a 3% increase from the $6.3 million reported in the third quarter of 2016. Gross margin decreased to 28% from 32% in the third quarter of 2016, primarily as a result of increase in scrap rates in production compared to the same quarter of last year.

R&D expenses for the third quarter of 2017 were $3.4 million, a decrease of 23% as compared to $4.4 million in the third quarter of 2016. Selling, general, and administrative expenses were $3.3 million, up 16% from $2.8 million in the same period in 2016. Operating loss was $0.3 million, significantly reduced from an operating loss of $1.0 million in the same period of 2016. Net loss for the third quarter of 2017 was $0.2 million, or $0.01 per diluted share, compared to a net loss of $1.0 million, or $0.03 per diluted share in the third quarter of 2016.

Adjusted EBITDA for the third quarter of 2017 was $0.8 million, compared with Adjusted EBITDA for the third quarter of 2016 of $0.2 million. Adjusted net loss for the third quarter of 2017 was less than $0.1 million, compared with an adjusted net loss of $0.7 million in the third quarter of 2016.

Nine Months Ended September 30, 2017 vs. September 30, 2016

Total revenues were $67.1 million, a 26% increase from $53.2 million in the same period of 2016. Revenues from the Proprietary Products segment were $50.6 million, a 32% increase from $38.3 million in the same period of 2016. Revenues from the Distributed Products segment were $16.5 million, a 11% increase from the $15.0 million reported in the nine-month period of 2016.

Gross profit was $20.5 million, a 23% increase from the $16.7 million reported in the same period of 2016. Gross margin was 30%, somewhat consistent with the 31% in the same period of 2016.

R&D expenses were $10.1 million, a decrease of 16% as compared to $12.0 million in the same period of 2016. Selling, general and administrative expenses were $9.4 million, an increase of 14% compared to $8.2 million in the same period of 2016. The Company reported operating income of $1.0 million, compared with an operating loss of $3.6 million in the same period of 2016. Net income was $0.6 million, or $0.02 per diluted share, compared with a net loss of $4.9 million, or $0.14 per diluted share, in the same period of 2016.

Adjusted EBITDA was $4.3 million, compared with Adjusted EBITDA of $0.1 million for the same period of 2016. Adjusted net income was $1.3 million compared to an adjusted net loss of $3.9 million in the same period of 2016.

Balance Sheet Highlights

As of September 30, 2017, the Company had cash, cash equivalents and short term investments of $40.1 million, compared with $28.6 million as of December 31, 2016, which reflects the closing of an offering of common stock during the third quarter. In the first nine months of 2017, Kamada used $0.1 million of cash in operations and invested $3.4 million in capital expenditures.

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 to $78 million and Distributed Products revenues between $22 to $24 million.

2018 Revenue Guidance

For the year ending December 31, 2018, Kamada is expecting total revenues to be in the range of $116 to $120 million

Conference Call

Kamada management will host an investment community conference call on Monday, November 13 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 877-741-4248 (from within the U.S.), 1 80 925 8243 (from Israel), or 719-325-4754 (International) and entering the conference identification number: 2675273. 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: 2675273. 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(R), the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA(R) 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(R), 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. 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’s rabies immune globulin (Human) product received FDA approval for Post-Exposure Prophylaxis against rabies infection in August 2017. 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, further 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:

Gil Efron

Deputy CEO & 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,
                                                                2017           2016             2016
                                                             Unaudited                     Audited
                                                             In thousands
Current Assets
Cash and cash equivalents                                    $  12,156      $  6,476       $    9,968
Short-term investments                                          27,986         20,722           18,664
Trade receivables, net                                          21,980         14,501           19,788
Other accounts receivables                                      2,683          4,022            3,063
Inventories                                                     23,144         28,086           25,594
                                                                87,949         73,807           77,077
Non-Current Assets
Property, plant and equipment, net                              23,597         20,720           22,249
Other long-term assets                                          443            71               370
                                                                24,040         20,791           22,619
                                                                111,989        94,598           99,696
Current Liabilities
Current maturities of loans
                                                                602            416              412
Trade payables                                                  12,004         8,916            16,277
Other accounts payables                                         6,299          4,744            5,614
Deferred revenues                                               4,816          4,858            4,903
                                                                23,721         18,934           27,206
Non-Current Liabilities
Loans                                                           1,501          1,502            1,364
Employee benefit liabilities, net                               1,000          798              722
Deferred revenues                                               2,057          4,693            3,661
                                                                4,558          6,993            5,747
Shareholder’s Equity
Ordinary shares                                                 10,399         9,320            9,320
Share premium                                                   177,193        162,649          162,671
Capital reserve due to translation to presentation currency     (3,490)        (3,490)          (3,490)
Capital reserve from hedges                                     57             52               (27)
Capital reserve from available for sale financial assets        34             87               19
Capital reserve from share-based payments                       10,413         9,768            9,795
Capital reserve from employee benefits                          (81)           (59)             (81)
Accumulated deficit                                             (110,815)      (109,656)        (111,464)
                                                                83,710         68,671           66,743
                                                             $  111,989     $  94,598      $    99,696
Consolidated Statements of Comprehensive Income (loss)
                                                                                   Nine months period       Three months period      Year ended
                                                                                   ended                    ended                    December 31
                                                                                   September 30,            September 30,
                                                                                      2017        2016         2017        2016          2016
                                                                                   Unaudited                                         Audited
                                                                                   In thousands (except for per-share data)
Revenues from proprietary products                                                 $  50,568   $  38,270    $  17,058   $  15,044    $   55,958
Revenues from distribution                                                            16,547      14,966       5,860       4,329         21,536
Total revenues                                                                        67,115      53,236       22,918      19,373        77,494
Cost of revenues from proprietary products                                            32,727      23,843       11,509      9,433         37,433
Cost of revenues from distribution                                                    13,930      12,711       4,961       3,664         18,411
Total cost of revenues                                                                46,657      36,554       16,470      13,097        55,844
Gross profit                                                                          20,458      16,682       6,448       6,276         21,650
Research and development expenses                                                     10,056      12,024       3,418       4,415         16,245
Selling and marketing expenses                                                        3,133       2,557        1,021       866           3,243
General and administrative expenses                                                   6,270       5,688        2,323       2,014         7,643
Operating income (loss)                                                               999         (3,587)      (314)       (1,019)       (5,481)
Financial income                                                                      266         388          92          90            469
Income (expense) in respect of currency exchange and derivatives instruments, net     (479)       (132)        -           (73)          127
Financial expense                                                                     (50)        (106)        (14)        (39)          (126)
Gain (loss) before taxes on income                                                    736         (3,437)      (236)       (1,041)       (5,011)
Taxes on income                                                                       87          1,488        -           -             1,722
Net income (loss)                                                                     649         (4,925)      (236)       (1,041)       (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                                    15          14           3           (32)          (54)
Gain (loss) on cash flow hedges                                                       303         124          (69)        44            47
Net amounts transferred to the statement of profit or loss for cash flow hedges       (219)       (71)         (103)       (1)           (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)                                                  $  748      $  (4,858)   $  (405)    $  (1,030)   $   (6,835)
Earnings (loss) per share attributable to equity holders of the Company:
Basic earnings (loss) per share                                                    $  0.02     $  (0.14)    $  (0.01)   $  (0.03)    $   (0.18)
Diluted earnings (loss) per share                                                  $  0.02     $  (0.14)    $  (0.01)   $  (0.03)    $   (0.18)
CONSOLIDATED STATEMENTS OF CASH FLOWS
                                                       Nine months period Ended   Three months period Ended   Year Ended
                                                       September 30,              September 30,               December 31,
                                                              2017       2016          2017          2016         2016
                                                       Unaudited                                              Audited
                                                       In thousands
Cash Flows from Operating Activities
Net gain (loss)                                        $      649      $ (4,925)  $    (236)    $    (1,041)  $   (6,733)
Adjustments to reconcile gain (loss) to net cash
provided by (used in) operating activities:
Adjustments to the profit or loss items:
Depreciation, amortization and impairment of equipment        2,648      2,631         903           922          3,501
Finance expense ( income), net                                263        (150)         (78)          22           (470)
Cost of share-based payment                                   659        1,022         218           313          1,071
Income tax expense                                            87         1,488         -             -            1,722
Loss (gain) from sale of property and equipment               (49)       (23)          (4)           (33)         (18)
Change in employee benefit liabilities, net                   278        11            137           396          (87)
                                                              3,886      4,979         1,176         1,620        5,719
Changes in asset and liability items:
Decrease (increase) in trade receivables, net                 (2,924)    8,948         863           1,644        3,489
Decrease  in other accounts receivables                       (393)      (654)         (547)         (801)        211
Decrease (increase) in inventories                            2,450      (1,750)       928           235          742
Decrease (increase) in deferred expenses                      872        (487)         (132)         287          (433)
Decrease in trade payables                                    (3,885)    (8,277)       (1,906)       (1,408)      (2,650)
Increase in other accounts payables                           716        681           (473)         (45)         1,520
Increase (decrease)  in deferred revenues                     (1,691)    2,022         (1,238)       (987)        1,035
                                                              (4,855)    483           (2,505)       (973)        3,914
Cash received (paid) during the period for:
Interest paid                                                 (16)       (46)          (7)           (37)         (60)
Interest received                                             266        657           117           233          842
Taxes paid                                                    (14)       (1,781)       (4)           (1,475)      (1,785)
                                                              236        (1,170)       106           (1,279)      (1,003)
Net cash provided by (used in) operating activities    $      (84)     $ (633)    $    (1,459)  $    (1,673)  $   1,897
CONSOLIDATED STATEMENTS OF CASH FLOWS
                                                                  Nine months period         Three months period         Year Ended
                                                                  Ended                      Ended
                                                                  September 30,              September 30,               December 31,
                                                                         2017        2016            2017          2016          2016
                                                                  Unaudited                                              Audited
                                                                  Thousands of US dollars
Cash Flows from Investing Activities
Proceeds from sale of (investment in) short term investments, net $      (9,068)   $ 2,369       $   (12,041)  $   1,593     $   4,236
Purchase of property and equipment                                       (3,407)     (1,904)         (792)         (435)         (2,641)
Proceeds from sale of property and equipment                             57          41              4             20            42
Net cash provided by (used in) investing activities                      (12,418)    506             (12,829)      1,178         1,637
Cash Flows from Financing Activities
Proceeds from exercise of share base payment                             2         *                 1         *         *
Receipt of long-term loans                                               279         1,701           279           -             1,701
Repayment of long-term loans                                             (380)       (159)           (142)         (98)          (211)
Proceeds from issuance of ordinary shares, net                           15,558      -               15,558        -             -
Net cash provided by (used in) financing activities                      15,459      1,542           15,696        (98)          1,490
Exchange differences on balances of cash and cash equivalent             (769)       14              (276)         (67)          (103)
Increase (decrease) in cash and cash equivalents                         2,188       1,429           1,132         (660)         4,921
Cash and cash equivalents at the beginning of the period                 9,968       5,047           11,024        7,136         5,047
Cash and cash equivalents at the end of the period                $      12,156    $ 6,476       $   12,156    $   6,476     $   9,968
Significant non-cash transactions
Purchase of property and equipment through capital lease          $      282       $ 132         $   -         $   48        $   132
Purchase of property and equipment                                $      398       $ -           $   398       $   -         $   1,968

* Represents an amount of less than 1 thousand

Adjusted EBITDA
                                                                                         Nine months period Ended    Three months period             For the year
                                                                                         September 30,               Ended  September 30,            Ended December
                                                                                                                                                     31,
                                                                                             2017        2016              2017          2016        2016
                                                                                         Thousands of US dollars
Net income (loss)                                                                        $   649     $   (4,925)        $  (236)      $  (1,041)     $ (6,733)
Income tax expense                                                                           87          1,488             -             -             1,722
Financial expense (income), net                                                              (216)       (282)             (78)    (51)            (343)
Depreciation and amortization expense                                                        2,648       2,631             903           922           3,501
Share-based compensation charges                                                             659         1,022             218           313           1,071
Expense (Income) in respect of translation differences and derivatives instruments, net      479         132               -             73            (127)
Adjusted EBITDA                                                                          $   4,306   $   66             $  807        $  216         $ (909)
Adjusted net income
                                  Nine months period Ended  Three months period     For the Year
                                  September 30,             Ended September 30,     Ended
                                                                                    December 31,
                                      2017        2016         2017       2016           2016
                                  Thousands of US dollars
Net income (loss)                 $   649     $   (4,952)   $  (236)   $  (1,041)   $    (6,733)
Share-based compensation charges      659         1,022        218        313            1,071
Adjusted Net income (loss)        $   1,308   $   (3,930)   $  (18)    $  (728)     $    (5,662)

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