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Kamada Ltd.

Foreign Filer Report May 14, 2019

6874_rns_2019-05-14_06d8fe59-57c1-4bc5-b0a9-2933a79fc817.pdf

Foreign Filer Report

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934

For the Month of May 2019

Commission File Number 001-35948

Kamada Ltd.

(Translation of registrant's name into English)

2 Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ☐ No ☒

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____

This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos. 333-192720, 333-207933, 333-215983 and 333-222891, and the Registrant's Form F-3 Registration Statement, as amended, File No. 333-214816.

The following exhibit is attached:

99.1 Press Release: Kamada Reports Financial Results for First Quarter of 2019

99.2 Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2019 (Unaudited)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 14, 2019 KAMADA LTD.

By: /s/ Chaime Orlev

Chaime Orlev Chief Financial Officer

EXHIBIT INDEX

EXHIBIT NO. DESCRIPTION

99.1 Press Release: Kamada Reports Financial Results for First Quarter of 2019

99.2 Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2019 (Unaudited)

Exhibit 99.1

Kamada Reports Financial Results for First Quarter of 2019

Total Revenues for Q1 2019 were \$26.8 Million, up 54% over Q1 2018 Q1 2019 Proprietary Products Revenues up 67% Year-over-Year Gross Profit for Q1 2019 Grew 59% Year-over-Year Adjusted EBITDA was \$6.6 Million in Q1 2019, an Increase of 179% as Compared to \$2.4 Million in Q1 2018 Reiterating Full-Year 2019 Total Revenue Guidance of \$125 Million to \$130 Million

REHOVOT, Israel – May 14, 2019 -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three months ended March 31, 2019.

"We are extremely pleased with our solid start to 2019," said Amir London, Kamada's Chief Executive Officer. "Total revenues in the first quarter of 2019 were \$26.8 million, representing a 54% increase as compared to the first quarter of 2018. These results were primarily driven by increased sales of GLASSIA® and KedRAB®, our anti-rabies IgG product. From a profitability standpoint, our gross profits, as well as operating and net income, improved substantially year-over-year in the first quarter of 2019. We generated \$4.9 million in net income in the first quarter of 2019, an increase of over 292% as compared to net income of \$1.3 million in the 2018 first quarter."

"Based on our strong performance in the first quarter, and our positive outlook for the remainder of the year, we are reaffirming our full-year 2019 total revenue guidance of \$125 million to \$130 million, which, if achieved, would represent another strong year of double-digit percentage growth for Kamada over full-year 2018 total revenues," continued Mr. London. "This guidance reflects continued growth of both of our core products, GLASSIA and KedRAB, in 2019. As a reminder, our GLASSIA supply agreement with Takeda, which extends through the end of 2020, will be followed by an expected flow of future royalty payments for 20 years, until 2040."

"In addition to growing our commercial business, we are also advancing our clinical development pipeline. We announced recently the receipt of a letter from the U.S. Food and Drug Administration (FDA) stating that we have satisfactorily addressed the FDA's prior concerns and questions regarding Kamada's Inhaled AAT program. The FDA's response followed the positive scientific advice that we received in July 2018 from the Committee for Medicinal Products for Human Use of the European Medicines Agency. We intend to conduct a unified global pivotal Phase 3 clinical trial in the U.S. under an Investigational New Drug application and in Europe under a Clinical Trial Authorization in order to submit marketing applications for regulatory approval in both regions. We expect to initiate the Phase 3 study during the second half of 2019, subject to the successful completion of the FDA required Human Factor Study, which was recently initiated."

Financial Highlights for the Three Months Ended March 31, 2019

  • Total revenues were \$26.8 million in the first quarter of 2019, a 54% increase from the \$17.4 million recorded in the first quarter of 2018.
  • Revenues from the Proprietary Products segment in the first quarter of 2019 were \$20.4 million, a 67% increase from the \$12.2 million reported in the first quarter of 2018.
  • Revenues from the Distribution segment were \$6.4 million in the first quarter of 2019, a 23% increase from the \$5.2 million recorded in the first quarter of 2018.
  • Gross profit was \$11.2 million in the first quarter of 2019, a 59% increase from the \$7.0 million reported in the first quarter of 2018. Gross margin increased to 42% from 40% in the first quarter of 2018. The higher gross margins in the first quarters of 2019 and 2018 were due to a favorable product sales mix.
  • Operating expenses, including R&D, Sales & Marketing and G&A expenses, totaled \$6.0 million in the first quarter of 2019, as compared to \$5.8 million in the first quarter of 2018. As Kamada intends to initiate its Inhaled AAT Phase 3 clinical trial during the second half of 2019, the Company expects that its annual R&D expenses will increase for the full-year as compared to 2018.
  • Net income was \$4.9 million, or \$0.12 per share, in the first quarter of 2019, as compared to net income of \$1.3 million, or \$0.03 per share, in the first quarter of 2018.
  • Adjusted EBITDA, as detailed in the tables below, was \$6.6 million in the first quarter of 2019, as compared to \$2.4 million in the first quarter of 2018.
  • Cash provided by operating activities was \$6.1 million in the first quarter of 2019, as compared to cash provided by operating activities of \$5.4 million in the first quarter of 2018.

Balance Sheet Highlights

As of March 31, 2019, the Company had cash, cash equivalents, and short-term investments of \$55.8 million, as compared to \$50.6 million at December 31, 2018.

As of January 1, 2019, the Company adopted IFRS 16 (Leases), which resulted in an increase of property, plant and equipment, as well as bank loans and leases, in the amounts of \$4.1 million and \$4.7 million, respectively. Additional related information can be found in the Company's audited financial statements for the year ended December 31, 2018, included in our recently filed Annual Report on Form 20-F.

Recent Corporate Highlights

  • Received a letter from the FDA stating that the Company has satisfactorily addressed the FDA's previously communicated concerns and questions regarding Kamada's Inhaled Alpha-1-Antitrypsin (Inhaled AAT) program for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The Company intends to initiate a unified global pivotal Phase 3 clinical trial during the second half of 2019.
  • Announced interim results from the Company's Phase 2 trial of intravenous Alpha-1 Antitrypsin (IV-AAT) for the prevention of lung transplant rejection following one year of treatment for all patients.
  • Awarded the Israeli Outstanding Exporter Award for 2017 by the Foreign Trade Department of the Israeli Ministry of Economy and Industry.
  • Appointed Michal Ayalon, Ph.D., as Vice President of Research and Development.

Conference Call

Kamada management will host an investment community conference call on Tuesday, May 14 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 877-407-0792 (from within the U.S.), 1 809 406 247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13689683. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.

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 Takeda Pharmaceuticals Company Limited and in other counties through local distributors. Kamada's second leading product is KamRAB, a rabies immune globulin (Human) for Post-Exposure Prophylaxis against rabies infection. KamRAB is FDA approved and is being marketed in the U.S. under the brand name KEDRAB and through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, Kamada has a product line of four 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, its intravenous AAT is in development for other indications, such as GvHD, prevention of lung transplant rejection and type-1 diabetes. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 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, including statements regarding Kamada's continued revenue growth of our marketed proprietary products, including GLASSIA and KedRAB in the U.S., re-affirmation of the 2019 revenue guidance, our expectation for 20 years of royalties from Takeda post 2020, continued prospects in our development pipeline, including: the timing of the start of the unified global pivotal Phase 3 clinical trial in the second half of 2019 for the Inhaled AAT program and successful results from such a clinical trial, the successful completion of the Human Factor Study in the second quarter of 2019, which is a necessary component to start the clinical trial for the Inhaled AAT program, and our plans to submit marketing applications for regulatory approval in both the U.S. and Europe. 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 with the studies, additional competition in the markets that Kamada competes, including AAT, regulatory delays, prevailing market conditions, corporate events associated with our partners, including Takeda, 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 [email protected]

Bob Yedid LifeSci Advisors, LLC 646-597-6989 [email protected]

CONSOLIDATED BALANCE SHEETS

As of
March 31,
As of
December 31,
2019
2018
2018
Unaudited Audited
U.S Dollars in thousands
Current Assets
Cash and cash equivalents \$
22,037
\$ 17,497 \$ 18,093
Short-term investments 33,800 30,451 32,499
Trade receivables, net 23,210 17,083 27,674
Other accounts receivables 3,442 2,027 3,308
Inventories 31,708 28,175 29,316
114,197 95,233 110,890
Property, plant and equipment, net 28,829 25,125 25,004
Other long term assets 174 173 174
Deferred taxes 1,895 - 2,048
30,898 25,298 27,226
\$
145,095
\$ 120,531 \$ 138,116
Current Liabilities
Current maturities of bank loans and leases 1,431 609 562
Trade payables 15,255 16,951 17,285
Other accounts payables 4,424 4,912 5,261
Deferred revenues 461 4,977 461
21,571 27,449 23,569
Non-Current Liabilities
Bank loans and leases 4,627 1,201 716
Deferred revenues 605 645 668
Employee benefit liabilities, net 823 1,130 787
6,055 2,976 2,171
Shareholder's Equity
Ordinary shares 10,412 10,401 10,409
Additional paid in capital 179,352 178,458 179,147
Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)
Capital reserve from hedges 11 (12) (57)
Capital reserve from securities measured at fair value through other comprehensive income 118 (33) 34
Capital reserve from share-based payments 9,463 9,183 9,353
Capital reserve from employee benefits 4 (337) 4
Accumulated deficit (78,401) (104,064) (83,024)
117,469 90,106 112,376
\$
145,095
\$ 120,531 \$ 138,116

Consolidated Statements of Profit or Loss and Other Comprehensive Income (Loss)

Three months period ended
March 31,
2019 2018
Unaudited Audited
U.S Dollars in thousands
Revenues from proprietary products \$
20,381
\$
12,214
\$
90,784
Revenues from distribution 6,416 5,227 23,685
Total revenues 26,797 17,441 114,469
Cost of revenues from proprietary products 10,490 6,179 52,796
Cost of revenues from distribution 5,123 4,246 20,201
Total cost of revenues 15,613 10,425 72,997
Gross profit 11,184 7,016 41,472
Research and development expenses 2,766 2,754 9,747
Selling and marketing expenses 1,092 970 3,630
General and administrative expenses 2,094 2,064 8,525
Other expense 23
-
311
Operating income 5,209 1,228 19,259
Financial income 280 229 820
Financial expenses (123) (157) (340)
Income (expense) in respect of currency exchange differences and derivatives instruments, net (313) (44) 602
Income before taxes 5,053 1,256 20,341
Taxes on income 130 - (1,955)
Net Income 4,923 1,256 22,296
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 108 (29) 51
Gain (loss) on cash flow hedges 74
(37)
(176)
Net amounts transferred to the statement of profit or loss for cash flow hedges (2)
(21)
70
Items that will not be reclassified to profit or loss in subsequent periods:
Actuarial gain (loss) from defined benefit plans -
-
340
Deferred taxes (28) - (9)
Total comprehensive income \$
5,075
\$
1,169
\$
22,752
Income (loss) per share attributable to equity holders of the Company:
Basic income per share \$
0.12
\$
0.03
\$
0.55
Diluted income per share \$
0.12
\$
0.03
\$
0.55

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months period Ended
March 31,
Year Ended
December 31,
2019
2018
Unaudited
2018
Audited
U.S Dollars in
U.S Dollars in thousands thousands
Net income \$ 4,923 \$ 1,256 \$ 22,296
Adjustments to reconcile net income to net cash provided by operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment 1,127 954 3,703
Financial expenses (income), net 156 (28) (1,082)
Cost of share-based payment 315 201 948
Taxes on income 130 - (1,955)
Loss (gain) from sale of property and equipment (6) 66 55
Change in employee benefit liabilities, net 36 (14) (16)
1,758 1,179 1,653
Changes in asset and liability items:
Decrease in trade receivables, net 4,727 13,491 2,311
Decrease (increase) in other accounts receivables 131 82 (1,336)
Increase in inventories (2,392) (7,105) (8,246)
Decrease (increase) in deferred expenses (246) 22 235
Decrease in trade payables (2,368) (1,941) (1,116)
Decrease in other accounts payables (510) (888) (658)
Decrease in deferred revenues (63) (772) (5,256)
(721) 2,889 (14,066)
Cash received (paid) during the year for:
Interest paid (63) (16) (54)
Interest received 172 138 739
Taxes paid (8) (5) (22)
101 117 663
Net cash provided by operating activities \$ 6,061 \$ 5,441 \$ 10,546

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months period Ended
March 31,
Year Ended
December 31,
2019
2018
Unaudited
2018
Audited
U.S Dollars in
U.S Dollars in thousands
Cash Flows from Investing Activities
Investment in short term investments, net \$ (1,058) \$ (150) \$ (2,322)
Purchase of property and equipment and intangible assets (304) (259) (2,884)
Proceeds from sale of property and equipment 6 11 30
Net cash used in investing activities (1,356) (398) (5,176)
Cash Flows from Financing Activities
Proceeds from exercise of share base payments 3 1 9
Repayment of long-term loans (378) (152) (596)
Net cash used in financing activities (375) (151) (587)
Exchange differences on balances of cash and cash equivalent (386) (76) 629
Increase in cash and cash equivalents 3,944 4,816 5,412
Cash and cash equivalents at the beginning of the year 18,093 12,681 12,681
Cash and cash equivalents at the end of the year \$ 22,037 \$ 17,497 \$ 18,093
Significant non-cash transactions
Purchase of property and equipment through leases \$ 4,431 - -
Purchase of property and equipment \$ 235 \$ 842 \$ 720

Adjusted EBITDA

Three months period Ended Year ended
March 31, December 31,
2019 2018 2018
In thousands In thousands
Net income (loss) \$ 4,923 \$ 1,256 \$ 22,296
Taxes on income 130 - (1,955)
Financial expense (income), net 156 (72) (1,082)
Depreciation and amortization expense 1,127 954 3,703
Share-based compensation charges 315 201 948
Expense (Income) in respect of translation differences and derivatives instruments, net 313 44 (602)
\$ 6,964 \$ 2,383 \$ 23,308

Adjusted net income

Three months period Ended
March 31,
Year ended
December 31,
2019 2018 2018
In thousands In thousands
Net income \$ 4,923 \$ 1,256 \$ 22,296
Share-based compensation charges 315 201 948
Adjusted net income \$ 5,238 \$ 1,457 \$ 23,244

Exhibit 99.2

KAMADA LTD.

CONSOLIDATED FINANCIAL STATEMENTS

AS OF MARCH 31, 2019

TABLE OF CONTENTS

Page
Consolidated Balance Sheets 2
Consolidated Statements of Comprehensive Income 3
Consolidated Statements of Changes in Equity 4-6
Consolidated Statements of Cash Flows 7-8
Notes to the Consolidated Financial Statements 9-15

CONSOLIDATED BALANCE SHEETS

As of
March 31,
As of
December 31,
2019 2018 2018
Unaudited Audited
U.S Dollars in thousands
Current Assets
Cash and cash equivalents \$
22,037
\$ 17,497 \$
18,093
Short-term investments 33,800 30,451 32,499
Trade receivables, net 23,210 17,083 27,674
Other accounts receivables 3,442 2,027 3,308
Inventories 31,708 28,175 29,316
114,197 95,233 110,890
Property, plant and equipment, net 28,829 25,125 25,004
Other long term assets 174 173 174
Deferred taxes 1,895 - 2,048
30,898 25,298 27,226
\$
145,095
\$ 120,531 \$
138,116
Current Liabilities
Current maturities of bank loans and leases \$
1,431
\$ 609 \$
562
Trade payables 15,255 16,951 17,285
Other accounts payables 4,424 4,912 5,261
Deferred revenues 461
21,571
4,977
27,449
461
23,569
Non-Current Liabilities
Bank loans and leases
Deferred revenues
4,627 1,201 716
Employee benefit liabilities, net 605 645 668
823
6,055
1,130
2,976
787
2,171
Shareholder's Equity
Ordinary shares 10,412 10,401 10,409
Additional paid in capital 179,352 178,458 179,147
Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)
Capital reserve from hedges 11 (12) (57)
Capital reserve from securities measured at fair value through other comprehensive income 118 (33) 34
Capital reserve from share-based payments 9,463 9,183 9,353
Capital reserve from employee benefits
Accumulated deficit
4 (337) 4
(78,401)
117,469
(104,064)
90,106
(83,024)
112,376
\$
145,095
\$ 120,531 \$
138,116

The accompanying Notes are an integral part of the Consolidated Financial Statements.

Consolidated Statements of Comprehensive Income

Three months period ended
March 31,
2019 2018 December 31,
2018
Unaudited Audited
U.S Dollars in thousands
Revenues from proprietary products \$ 20,381 \$ 12,214 \$ 90,784
Revenues from distribution 6,416 5,227 23,685
Total revenues 26,797 17,441 114,469
Cost of revenues from proprietary products 10,490 6,179 52,796
Cost of revenues from distribution 5,123 4,246 20,201
Total cost of revenues 15,613 10,425 72,997
Gross profit 11,184 7,016 41,472
Research and development expenses 2,766 2,754 9,747
Selling and marketing expenses 1,092 970 3,630
General and administrative expenses 2,094 2,064 8,525
Other expense 23 - 311
Operating income 5,209 1,228 19,259
Financial income 280 229 820
Financial expenses (123) (157) (340)
Income (expense) in respect of currency exchange differences and derivatives instruments, net (313) (44) 602
Income before taxes 5,053 1,256 20,341
Taxes on income 130 - (1,955)
Net Income 4,923 1,256 22,296
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 108 (29) 51
Gain (loss) on cash flow hedges 74 (37) (176)
Net amounts transferred to the statement of profit or loss for cash flow hedges (2) (21) 70
Items that will not be reclassified to profit or loss in subsequent periods:
Actuarial gain (loss) from defined benefit plans - - 340
Deferred taxes (28) - (9)
Total comprehensive income \$ 5,075 \$ 1,169 \$ 22,752
Income (loss) per share attributable to equity holders of the Company:
Basic income per share \$ 0.12 \$ 0.03 \$ 0.55
Diluted income per share \$ 0.12 \$ 0.03 \$ 0.55

The accompanying Notes are an integral part of the Consolidated Financial Statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Share
capital
Additional
paid in
capital
Capital
reserve from
securities
measured at
fair value
through other
comprehensive
income
Capital
reserve
due to
translation
to presentation
currency
Capital
reserve
from
hedges
Unaudited
Capital
reserve from
sharebased
payments
Capital
reserve from
employee
benefits
Accumulated
deficit
Total
equity
U.S Dollars in thousands
Balance as of
January 1, 2019
(audited) \$ 10,409 \$ 179,147 \$ 34 \$ (3,490) \$ (57) \$ 9,353 \$ 4 \$ (83,024) \$
112,376
Cumulative effect
of initially applying
IFRS 16
- - - - - - - (300) (300)
Balance as at
January 1, 2018
(after initially
applying IFRS 15) 10,409 179,147 34 (3,490) (57) 9,353 4 (83,324) 112,076
net income - - - - - - - 4,923 4,923
Other
comprehensive
income, net
- - 84 - 68 - - - 152
Total
comprehensive
income (loss) - - 84 - 68 - - 4,923 5,075
Exercise and
forfeiture of share
based payment
into shares 3 205 - - - (205) - - 3
Cost of share
based payment
- - - - - 315 - - 315
Balance as of
March 31, 2019
\$ 10,412 \$ 179,352 \$ 118 \$ (3,490) \$ 11 \$ 9,463 \$ 4 \$ (78,401) \$
117,469

The accompanying Notes are an integral part of the Consolidated Financial Statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Additional
Share
paid in
capital
capital
Capital
reserve from
securities
measured at
fair value
through other
comprehensive
income
Capital
reserve
due to
translation
to presentation
currency
Capital
reserve
from
hedges
Unaudited
U.S Dollars in thousands
Capital
reserve from
sharebased
payments
Capital
reserve from
employee
benefits
Accumulated
deficit
Total
equity
Balance as of
January 1, 2018
(audited) \$
10,400
\$ 177,874 \$ (4) \$ (3,490) \$ 46 \$
9,566
\$ (337) \$
(104,563)
\$ 89,492
Cumulative effect
of initially applying
IFRS 15 - - - - - - - (757) (757)
Balance as at
January 1, 2018
(after initially
applying IFRS 15) 10,400 177,874 (4) (3,490) 46 9,566 (337) (105,320) 88,735
Net income - - - - - - - 1,256 1,256
Other
comprehensive
loss
- - (29) - (58) - - - (87)
Total
comprehensive
income (loss) - - (29) - (58) - - 1,256 1,169
Exercise and
forfeiture of share
based payment
into shares 1 584 - - - (584) - - 1
Cost of share
based payment - - - - - 201 - - 201
Balance as of
March 31, 2018 \$
10,401
\$ 178,458 \$ (33) \$ (3,490) \$ (12) \$
9,183
\$ (337) \$
(104,064)
\$ 90,106

The accompanying Notes are an integral part of the Consolidated Financial Statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Additional
Share
paid in
capital
capital
Capital
reserve from
securities
measured at
fair value
through other
comprehensive
income
Capital
reserve
due to
translation
to presentation
currency
Capital
reserve
from
hedges
Audited
Capital
reserve from
sharebased
payments
Capital
reserve from
employee
benefits
Accumulated
deficit
Total
equity
U.S Dollars in thousands
Balance as of
January 1, 2018
(audited)
Cumulative effect
of initially applying
\$ 10,400 \$ 177,874 \$ (4) \$ (3,490) \$ 46 \$ 9,566 \$ (337) \$ (104,563) \$
89,492
IFRS 15
Balance as at
January 1, 2018
(after initially
- - - - - - - (757) (757)
applying IFRS 15)
net income
10,400
-
177,874
-
(4)
-
(3,490)
-
46
-
9,566
-
(337)
-
(105,320)
22,296
88,735
22,296
Other
comprehensive
income
Total
comprehensive
- - 38 - (103) - 341 - 276
income (loss)
Exercise and
forfeiture of share
based payment
- - 38 - (103) - 341 22,296 22,572
into shares 9 1,161 - - - (1,161) - - 9
Cost of share
based payment
- - - - - 948 - - 948
Deferred taxes
Balance as of
December 31, 2018
- 112 - - - - - - 112
(audited) \$ 10,409 \$ 179,147 \$ 34 \$ (3,490) \$ (57) \$ 9,353 \$ 4 \$ (83,024) \$
112,376

The accompanying Notes are an integral part of the Consolidated Financial Statements.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months period Ended
March 31,
2019
2018
Year Ended
December 31,
2018
Audited
Unaudited
U.S Dollars in thousands
Net income \$ 4,923 \$ 1,256 \$ thousands
22,296
Adjustments to reconcile net income to net cash provided by operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment 1,127 954 3,703
Financial expenses (income), net 156 (28) (1,082)
Cost of share-based payment 315 201 948
Taxes on income 130 - (1,955)
Loss (gain) from sale of property and equipment (6) 66 55
Change in employee benefit liabilities, net 36 (14) (16)
1,758 1,179 1,653
Changes in asset and liability items:
Decrease in trade receivables, net 4,727 13,491 2,311
Decrease (increase) in other accounts receivables 131 82 (1,336)
Increase in inventories (2,392) (7,105) (8,246)
Decrease (increase) in deferred expenses (246) 22 235
Decrease in trade payables (2,368) (1,941) (1,116)
Decrease in other accounts payables (510) (888) (658)
Decrease in deferred revenues (63) (772) (5,256)
(721) 2,889 (14,066)
Cash received (paid) during the year for:
Interest paid (63) (16) (54)
Interest received 172 138 739
Taxes paid (8) (5) (22)
101 117 663
Net cash provided by operating activities \$ 6,061 \$ 5,441 \$ 10,546

The accompanying Notes are an integral part of the Consolidated Financial Statements.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months period Ended
March 31,
2019
2018
Unaudited
Year Ended
December 31,
2018
Audited
U.S Dollars in thousands
Cash Flows from Investing Activities
Investment in short term investments, net \$ (1,058) \$ (150) \$
(2,322)
Purchase of property and equipment and intangible assets (304) (259) (2,884)
Proceeds from sale of property and equipment 6 11 30
Net cash used in investing activities (1,356) (398) (5,176)
Cash Flows from Financing Activities
Proceeds from exercise of share base payments 3 1 9
Repayment of long-term loans (378) (152) (596)
Net cash used in financing activities (375) (151) (587)
Exchange differences on balances of cash and cash equivalent (386) (76) 629
Increase in cash and cash equivalents 3,944 4,816 5,412
Cash and cash equivalents at the beginning of the year 18,093 12,681 12,681
Cash and cash equivalents at the end of the year \$ 22,037 \$ 17,497 \$
18,093
Significant non-cash transactions
Purchase of property and equipment through capital lease \$ 4,431 - -
Purchase of property and equipment \$ 235 \$ 842 \$
720

The accompanying Notes are an integral part of the Consolidated Financial Statements.

Note 1:- General

These Financial Statements have been prepared in a condensed format as of March 31, 2019 and for the three months then ended ("interim consolidated financial statements").

These financial statements should be read in conjunction with the Company's annual financial statements as of December 31, 2018 and for the year then ended and the accompanying notes ("annual consolidated financial statements").

Note 2:- Significant Accounting Policies

a. Basis of preparation of the interim consolidated financial statements:

The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, "Interim Financial Reporting".

b. Implementation of new accounting standards

The accounting policy applied in the preparation of the interim consolidated financial statements is consistent with that applied in the preparation of the annual consolidated financial statements, except for the following:

1. IFRS 16 – Leases

IFRS 16, replaced IAS 17 (Leases), and affected the accounting treatment for lessees with respect to leased assets. Pursuant to IFRS 16, all leases (except short term leases and small asset leases) were recognized in the balance sheet. Initially, the lease liability and the right-of-use asset are measured at the present value of future lease payments (defined as economically unavoidable payments). The right-of-use asset is subsequently depreciated in a similar way to other assets such as tangible assets, i.e. typically in a straight-line over the lease term. Lessees are required to separately recognize the interest expense on the lease liability and the depreciation expense on the right-of-use asset. Lessees are also required to re-measure the lease liability upon the occurrence of certain events (e.g., a change in the lease term, a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee generally recognizes the amount of the re-measurement of the lease liability as an adjustment to the right-of-use asset.

The new Standard is effective for annual periods beginning on or after January 1, 2019.

Note 2:- Significant Accounting Policies (Cont.)

The Company adopted IFRS 16 using the cumulative effect method without changing comparative information. The cumulative impact adjusted the opening balance of the equity at the date of initial application (i.e. January 1, 2019). In some leases, the right-of-use-assets were recognized based on the amount equal to the lease liabilities, adjusted for any prepaid and accrued lease payments previously recognized. The Company elected to apply the standard to contracts that were previously identified as leases applying IAS 17. The Company therefore did not apply the standard to contracts that were not previously identified as containing a lease applying IAS 17.

The Company elected to use the exemptions proposed by the standard with respect to lease contracts for which the underlying asset is of low value. The Company has leases of certain office equipment (i.e., printing and photocopying machines) that are considered of low value.

The Company also applied the available practical expedients wherein it: (i) used a single discount rate to a portfolio of leases with reasonably similar characteristics, (ii) relied on its assesments on whether leases are onerous immediately before the date of initial application, (iii) used hindsight in determining the lease term where the contract contains options to extend or terminate the lease and (iv) Applied the short-term leases exemptions to leases with lease term that ends within 12 months at the date of initial application.

Impact on the statement of financial position (increase/(decrease)) as at January 1, 2019, March 31,2019 and on the results for the reporting period ended at March 31, 2019 is presented below:

accounting policy
Difference
accounting policy
U.S Dollars in thousands
As of January 01, 2019
Assets
Property, plant and equipment (right-of-use assets)
\$
25,004
\$
4,162
\$
Liabilities
Current maturities of bank loans and leases
562
810
Bank loans and leases
716
3,907
Other accounts paybles
5,261
(255)
Shareholder's Equity
Accumulated deficit
\$
112,376
\$
(300)
\$
As of March 31, 2019
Assets
Property, plant and equipment (right-of-use assets)
\$
24,771
\$
4,058
\$
Liabilities
According to the
previous
According to the
current
29,166
1,372
4,623
5,006
112,076
28,829
Current maturities of bank loans and leases 599 832 1,431
Bank loans and leases
689
3,938
4,627

Note 2:- Significant Accounting Policies (Cont.)

The lease liabilities as at January 1, 2019 can be reconciled to the operating lease commitments as of December 31, 2018 as follows:

U.S Dollars
In thousands
Operating lease commitments as at December 31, 2018 \$ 5,434
Weighted average incremental borrowing rate as at January 1, 2019 3.06%-4.6%
Discounted operating lease commitment at January 1, 2019 4,685
Add:
Payments relating to leases of other equipment 32
Commitments relating to leases previously classified as finance leases 138
Lease liabilities as at January 1, 2019 \$ 4,855

Amount recognized in the ststement of financial position and profit or loss

Set out below, are the carrying amounts of the Group's right-of-use assets and lease liabilities and the movements during the period:

Right-of-use-assets
Rented
Offices
Vehicles and
other equipment
Total Lease
liabilities
U.S Dollars in thousands
As at January 1, 2019 \$ 3,466 \$ 696 \$ 4,162 \$
4,855
Additions - 141 141 270
Write-off - (16) (16) (17)
Depreciation expense (108) (121) (229) -
Interest expense - - - 153
Payments - - - (263)
As at March 31, 2019 \$ 3,358 \$ 700 \$ 4,058 \$
4,998
Expense
decrease
(increase)
U.S Dollars in
thousands
For the three months ended on March 31, 2019
Operating lease expense
Depreciation of right of use assets
\$ 276
(229)
Operating income 47

Finance expense (51) Net Income (loss) \$ (4)

Note 2:- Significant Accounting Policies (Cont.)

According to the
previous
accounting policy
According to the
current
Difference
accounting policy
U.S Dollars in thousands
For the three months ended on March 31, 2019
Cash flows
Cash flows from operating activities \$
5,836
225
6,061
Cash flows from financing activities \$
(150)
(225)
(375)
Operating Segments
Note 3:-
a.
General:
The company has two operating segments, as follows:
Proprietary Products - Medicine development, manufacture and sale of plasma-derived therapeutics products.
Distribution -
derivatives products.
Distribution of drugs in Israel manufacture by third parties, majority of which are produced from plasma or its
b.
Reporting on operating segments:
Proprietary
Products Distribution
Total
U.S Dollars in thousands
Unaudited
Three months period ended March 31, 2019
Revenues \$
20,381
\$
6,416
\$
26,797
Gross profit \$
9,891
\$
1,293
\$
11,184
Unallocated corporate expenses (5,975)
Finance expenses, net (156)
Income before taxes on income \$
5,053

Note 3:- Operating Segments (cont.)

b. Reporting on operating segments:

Proprietary
Products Distribution Total
U.S Dollars in thousands
Unaudited
Three months period ended March 31, 2018
Revenues \$ 12,214 \$ 5,227 \$ 17,441
Gross profit \$ 6,035 \$ 981 \$ 7,016
Unallocated corporate expenses (5,788)
Finance expenses, net 28
Income before taxes on income \$ 1,256
Proprietary
Products Distribution Total
U.S Dollars in thousands
Audited
Year Ended December 31, 2018
Revenues \$ 90,784 \$ 23,685 \$ 114,469
Gross profit \$ 37,988 \$ 3,484 \$ 41,472
Unallocated corporate expenses (22,213)
Finance expenses, net 1,082
Income before taxes on income \$ 20,341

Note 3:- Operating Segments (cont.)

c. Reporting on operating segments by geographic region:

Three months period ended March 31, 2019
Proprietary
Products
Distribution Total
U.S Dollars in thousands
Unaudited
Geographical markets
U.S.A. \$
18,062
\$ - \$ 18,062
Israel 547 6,416 6,963
Europe 873 - 873
Latin America 239 - 239
Asia & others 660 - 660
\$
20,381
\$ 6,416 \$ 26,797

Three months period ended March 31, 2018

Proprietary

Products Distribution Total U.S Dollars in thousands Unaudited Geographical markets U.S.A. \$ 9,373 \$ - \$ 9,373 Israel 1,029 5,227 6,256 Europe 1,386 - 1,386 Latin America 108 - 108 Asia & others 318 - 318 \$ 12,214 \$ 5,227 \$ 17,441

Year ended December 31, 2018

Proprietary
Products
Distribution Total
U.S Dollars in thousands
Audited
Geographical markets
U.S.A. \$
75,331
\$ - \$ 75,331
Israel 4,408 23,685 28,093
Europe 3,594 - 3,594
Latin America 3,994 - 3,994
Asia & others 3,457 - 3,457
\$
90,784
\$ 23,685 \$ 114,469

Note 4:- Financial Instruments

a. Classification of financial instruments by fair value hierarchy

Financial assets (liabilities) measured at fair value

Level 1 Level 2
U.S Dollars in thousands
March 31, 2019
Fair value through other comprehensive income :
Debt securities (corporate and government) \$
1,661
\$ 8,849
Derivatives instruments - 19
\$
1,661
\$ 8,868
March 31, 2018
Fair value through other comprehensive income :
Debt securities (corporate and government) \$
1,578
\$ 8,711
Derivatives instruments - *
\$
1,578
\$ 8,711
December 31, 2018
Fair value through other comprehensive income:
Debt securities (corporate and government) \$
1,588
\$ 8,736
Derivatives instruments - (64)
\$
1,588
\$ 8,672

* Represent an amount of less 1 thousand.

b. During the three months ended on March 31, 2019 there were no transfers due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.

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