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Kamada Ltd.

Earnings Release Nov 12, 2018

6874_rns_2018-11-12_a73983c1-7b0c-44f0-8666-e2eea3888af9.pdf

Earnings Release

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

  • 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 – November 12, 2018 -- 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, tissueprotective 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 forwardlooking 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 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
Capital reserve due to translation to presentation
178,873 177,193 177,874
currency (3,490) (3,490) (3,490)
Capital reserve from hedges
Capital reserve from fair value financial assets
(8) 57 46
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
December
31,
2017
September 30,
2018
2017 September 30,
2018
Unaudited 2017 Audited
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
September, 30
Three months period Ended
September, 30
Year Ended
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
Increase (decrease) in other accounts
(6,394) (3,885) (4,786) (1,906) (838)
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
September, 30
Three months period
Ended
Year
Ended
December
2018 2017 2018 September, 30
2017
31,
2017
Unaudited Audited
In thousands
Cash Flows from Investing Activities
Proceeds from sale of (investment in) short
term investments, net
Purchase of property and equipment and
\$(1,747) \$ (9,068) \$207 \$ (12,041) \$(11,501)
intangible assets
Proceeds from sale of property and equipment
(2,033)
15
(3,407)
57
(534)
-
(792)
4
(4,167)
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
September 30,
Three months period ended
September 30,
Year ended
December 31,
2018 2017 2018 2017 2017
Thousands of US dollar
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
September 30,
Three months period ended
September 30,
Year ended
December 31,
2018 2017 2018 2017 2017
Thousands of US dollar
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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