EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1

Kamada Reports Financial Results for Third Quarter and First Nine Months of 2019


Total Revenues for Third Quarter and First Nine Months of 2019 were $33.1 Million and $95.1 Million, Respectively, Compared to $15.0 Million and $66.3 Million in the Respective Periods in 2018.


As a Reminder, Kamada’s Third Quarter 2018 Performance was Impacted by the Then Labor Strike in the Company’s Manufacturing Facility.


Gross Profit for Third Quarter and First Nine Months of 2019 was $12.9 Million and $37.6 Million, Respectively, Compared to $2.5 Million and $20.2 Million in the Respective Periods in 2018.


Net Income for Third Quarter and First Nine Months of 2019 was $5.8 Million and $16.9 Million, Respectively, Compared to Net Loss of $2.4 Million and Net Income of $4.6 Million in the Respective Periods in 2018.


Reiterating Full-Year 2019 Total Revenue Guidance of $125 Million to $130 Million and Intends to Provide 2020 Revenue Guidance Prior to the End of 2019.

REHOVOT, Israel – November 13, 2019 -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three months and nine months ended September 30, 2019.

“We are pleased with our continued strong performance in the third quarter and year-to-date 2019,” said Amir London, Kamada’s Chief Executive Officer.  “For the third quarter of 2019, total revenues were $33.1 million, a 121% increase compared to the third quarter of 2018, which, as a reminder, was negatively impacted by our manufacturing facility labor strike.  For the first nine months of 2019, total revenues were $95.1 million, representing a 44% increase over the first nine months of 2018. Based on our continued strong performance in the third quarter, and our positive outlook for the fourth quarter of the year, we expect to achieve our full-year 2019 total revenue guidance of $125 million to $130 million.

“Our overall gross profit was $12.9 million and $37.6 million during the third quarter and nine months ended September 30, 2019, respectively,” continued Mr. London.  “Gross margins in our Proprietary Products segment for both the third quarter and the first nine months of 2019 were 47%, and our adjusted EBITDA for the third quarter and the first nine months of 2019 was $7.2 million and $21.7 million, respectively.  Our cash, cash equivalents and short-term investments were $66.8 million as of September 30, 2019, an increase of $16.2 million compared to the end of 2018.”

“As recently announced, we extended our strategic supply agreement with Takeda for GLASSIA® and we will continue to produce the product for the U.S. market through 2021.  Takeda intends to complete the technology transfer of the product and pending FDA approval, will commence its own production of GLASSIA for the U.S. market,” continued Mr. London.  “Based on the extended agreement, we project that total revenues from sales of GLASSIA to Takeda in 2019-2021 will be in the range of $155 million to $180 million.  While the transition of GLASSIA manufacturing to Takeda during 2021 will result in a significant reduction of Kamada’s revenues, based on current GLASSIA sales in the U.S. and forecasted future growth, we expect to receive a flow of future royalty payments from Takeda in the range of $10 million to $20 million per year from 2022 to 2040.”

“We can also report important progress in our clinical development pipeline.  During the third quarter, we submitted our amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for our proprietary inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).  We expect an update from the agency on the status of this filing in the near future.  We expect to begin dosing the first patient in the Phase 3 trial in Europe before the end of 2019, and pending IND approval, we will also begin recruiting patients for this study in the U.S.,” concluded Mr. London.


Financial Highlights for the Three Months Ended September 30, 2019

Total revenues were $33.1 million in the third quarter of 2019, a 121% increase from the $15.0 million recorded in the third quarter of 2018.  As a reminder, Kamada’s third quarter 2018 financial results were impacted by the then labor strike in the Company’s manufacturing facility

Revenues from the Proprietary Products segment in the third quarter of 2019 were $24.9 million, a 163% increase from the $9.5 million reported in the third quarter of 2018

Revenues from the Distribution segment were $8.2 million in the third quarter of 2019, a 49% increase from the $5.5 million recorded in the third quarter of 2018

Gross profit was $12.9 million in the third quarter of 2019, a 411% increase from the $2.5 million reported in the third quarter of 2018.  Gross margin increased to 39% from 17% in the third quarter of 2018

Operating expenses, including R&D, Sales & Marketing, G&A, and Other expenses, totaled $7.2 million in the third quarter of 2019, as compared to $5.0 million in the third quarter of 2018.  As Kamada is in the process of initiating its Inhaled AAT Phase 3 clinical and the first patient in the trial is expected to be enrolled before the end of the year. The Company continues to expect that its annual R&D expenses will increase for full-year 2019 as compared to 2018

Net income was $5.8 million or $0.14 per share, in the third quarter of 2019, as compared to a net loss of $2.4 million, or ($0.06) per share, in the third quarter of 2018

Adjusted EBITDA, as detailed in the tables below, was $7.2 million in the third quarter of 2019, as compared to ($1.4) million in the third quarter of 2018

Cash provided by operating activities was $6.1 million in the third quarter of 2019, as compared to cash provided by operating activities of $1.0 million in the third quarter of 2018

Financial Highlights for the Nine Months Ended September 30, 2019

Total revenues were $95.1 million in the first nine months of 2019, a 44% increase from the $66.3 million recorded in the first nine months of 2018.  As a reminder, Kamada’s financial results for the nine months ended September 30, 2018, were impacted by the third quarter 2018 labor strike in the Company’s manufacturing facility

Revenues from the Proprietary Products segment for the first nine months of 2019 were $72.5 million, a 52% increase from the $47.6 million reported in the first nine months of 2018

Revenues from the Distribution segment were $22.6 million in the first nine months of 2019, a 21% increase from the $18.6 million recorded in the first nine months of 2018

Gross profit was $37.6 million in the first nine months of 2019, an 86% increase from the $20.2 million reported in the first nine months of 2018.  Gross margin increased to 40% from 31% in the first nine months of 2018

Operating expenses, including R&D, Sales & Marketing and G&A, and Other expenses, totaled $20.3 million in the first nine months of 2019, as compared to $16.3 million in the first nine months of 2018

Net income was $16.9 million, or $0.42 per share, in the first nine months of 2019, as compared to net income of $4.6 million, or $0.11 per share, in the first nine months of 2018

Adjusted EBITDA, as detailed in the tables below, was $21.6 million in the first nine months of 2019, as compared to $7.4 million in the first nine months of 2018

Cash provided by operating activities was $18.9 million in the first nine months of 2019, as compared to cash provided by operating activities of $4.2 million in the first nine months of 2018


Balance Sheet Highlights
As of September 30, 2019, the Company had cash, cash equivalents, and short-term investments of $66.8 million, as compared to $50.6 million at December 31, 2018.

Recent Corporate Highlights

Extended strategic supply agreement with Takeda for GLASSIA supply through 2021

Submitted to the FDA an amended IND to conduct a Phase 3 clinical trial of inhaled AAT for the treatment of AATD

Hosted a scientific meeting entitled, “New Insights Into Alpha-1 Deficiency,” focused on up-to-date data regarding the suggested benefits of augmentation therapy in AATD around the European Respiratory Congress

Announced that the results of the registration study for KEDRAB® [Rabies Immune Globulin (Human)] were published in Human Vaccines & Immunotherapeutics, a peer-reviewed medical journal covering research into vaccines and immunotherapeutics in humans

Conference Call
Kamada management will host an investment community conference call on Wednesday, November 13th 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: 13695272.

The call will also be webcast live on the Internet 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 re-affirmation of the 2019 revenue guidance, our positive outlook for the fourth quarter of the year, our projected total revenues from sales of GLASSIA to Takeda during the years 2019-2021 will be in the range of $155 million to $180 million, our expectation to receive a flow of future royalty payments from Takeda in the range of $10 million to $20 million per year from 2022 to 2040, our expectation to receive an update from the FDA on the status of our recently filed IND amendment application with respect to our Phase 3 clinical trial for Inhaled AAT, the timing of the start of dosing of first patients in the Phase 3 clinical trial for Inhaled AAT in Europe before the end of this year and in the U.S. following IND amendment approval and expectation of higher R&D expenses due to initiation of the Phase 3 clinical trial for Inhaled AAT. 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
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,
 
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
   
U.S Dollars in thousands
 
Current Assets
                 
Cash and cash equivalents
 
$
27,449
   
$
12,871
   
$
18,093
 
Short-term investments
   
39,380
     
32,051
     
32,499
 
Trade receivables, net
   
23,999
     
14,826
     
27,674
 
Other accounts  receivables
   
1,722
     
1,858
     
3,308
 
Inventories
   
34,031
     
28,934
     
29,316
 
Total Current Assets
   
126,581
     
90,540
     
110,890
 
                         
Property, plant and equipment, net
   
28,297
     
24,406
     
25,004
 
Other long term assets
   
178
     
176
     
174
 
Deferred taxes
   
1,445
     
-
     
2,048
 
Total Non-Current Assets
   
29,920
     
24,581
     
27,226
 
Total Assets
 
$
156,501
   
$
115,121
   
$
138,116
 
                         
Current Liabilities
                       
Current maturities of bank loans and leases
 
$
1,537
   
$
585
   
$
562
 
Trade payables
   
13,079
     
11,512
     
17,285
 
Other accounts payables
   
5,439
     
4,662
     
5,261
 
Deferred revenues
   
561
     
1,854
     
461
 
Total Current Liabilities
   
20,616
     
18,613
     
23,569
 
                         
Non-Current Liabilities
                       
                         
Bank loans and leases
   
4,513
     
880
     
716
 
Deferred revenues
   
347
     
677
     
668
 
Employee benefit liabilities, net
   
884
     
1,035
     
787
 
Total Non-Current Liabilities
   
5,744
     
2,592
     
2,171
 
                         
Shareholder's Equity
                       
Ordinary shares
   
10,420
     
10,406
     
10,409
 
Additional paid in capital
   
179,589
     
178,873
     
179,147
 
Capital reserve due to translation to presentation currency
   
(3,490
)
   
(3,490
)
   
(3,490
)
Capital reserve from hedges
   
18
     
(8
)
   
(57
)
Capital reserve from securities measured at fair value through other comprehensive income
   
137
     
(5
)
   
34
 
Capital reserve from share-based payments
   
9,898
     
9,246
     
9,353
 
Capital reserve from employee benefits
   
4
     
(337
)
   
4
 
Accumulated deficit
   
(66,435
)
   
(100,769
)
   
(83,024
)
Total Shareholder’s Equity
   
130,141
     
93,916
     
112,376
 
Total Liabilities and Shareholder’s Equity
 
$
156,501
   
$
115,121
   
$
138,116
 





CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

   
Nine months period ended
   
Three months period ended
   
Year ended
 
   
September 30,
   
September 30,
   
December 31,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Unaudited
   
Audited
 
   
U.S Dollars In thousands
 
                               
Revenues from proprietary products
 
$
72,521
   
$
47,646
   
$
24,859
     
9,454
   
$
90,784
 
Revenues from distribution
   
22,595
     
18,612
     
8,207
     
5,521
     
23,685
 
                                         
Total revenues
   
95,116
     
66,258
     
33,066
     
14,975
     
114,469
 
                                         
Cost of revenues from proprietary products
   
38,412
     
30,506
     
13,234
     
7,869
     
52,796
 
Cost of revenues from distribution
   
19,056
     
15,536
     
6,968
     
4,587
     
20,201
 
                                         
Total cost of revenues
   
57,468
     
46,042
     
20,202
     
12,456
     
72,997
 
                                         
Gross profit
   
37,648
     
20,216
     
12,864
     
2,519
     
41,472
 
                                         
Research and development expenses
   
9,730
     
7,174
     
3,477
     
2,323
     
9,747
 
Selling and marketing expenses
   
3,441
     
2,724
     
1,161
     
818
     
3,630
 
General and administrative expenses
   
6,851
     
6,132
     
2,230
     
1,902
     
8,525
 
Other expenses and (incomes)
   
327
     
311
     
299
     
-
     
311
 
Operating income ( loss)
   
17,299
     
3,875
     
5,697
     
(2,524
)
   
19,259
 
                                         
Financial income
   
887
     
628
     
328
     
214
     
830
 
Financial expenses
   
(217
)
   
(145
)
   
(68
)
   
(39
)
   
(172
)
Change in fair value of debt securities
   
(3
)
   
(152
)
   
55
     
(45
)
   
(178
)
Income (expense) in respect of currency exchange differences and derivatives instruments, net
   
(503
)
   
334
     
25
     
3
     
602
 
Income ( loss) before taxes
   
17,463
     
4,540
     
6,037
     
(2,391
)
   
20,341
 
Taxes on income
   
574
     
(11
)
   
214
     
-
     
(1,955
)
                                         
Net Income ( loss)
   
16,889
     
4,551
     
5,823
     
(2,391
)
   
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
   
132
     
(1
)
   
(66
)
   
28
     
51
 
Gain (loss) on cash flow hedges
   
99
     
(88
)
   
28
     
56
     
(176
)
Net amounts transferred to the statement of profit or loss for cash flow hedges
   
(20
)
   
34
     
(18
)
   
27
     
70
 
Items that will not be reclassified to profit or loss in subsequent periods:
                                       
Actuarial gain (loss) from defined benefit plans
   
-
     
-
     
-
     
-
     
340
 
Deferred taxes
   
(33
)
   
-
     
16
     
-
     
(9
)
Total comprehensive income (loss)
 
$
17,067
   
$
4,496
   
$
5,783
   
$
(2,280
)
 
$
22,572
 
                                         
Income (loss) per share attributable to equity holders of the Company:
                                       
Basic income (loss) per share
 
$
0.42
   
$
0.11
   
$
0.14
   
$
(0.06
)
 
$
0.55
 
Diluted income (loss) per share
 
$
0.42
   
$
0.11
   
$
0.14
   
$
(0.06
)
 
$
0.55
 



CONSOLIDATED STATEMENTS OF CASH FLOWS

   
Nine months period Ended
   
Three months period Ended
   
Year Ended
 
   
September, 30
   
September, 30
   
December 31,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
   
U.S Dollars In thousands
 
Cash Flows from Operating Activities
                             
Net income
 
$
16,889
   
$
4,551
   
$
5,823
   
$
(2,391
)
 
$
22,296
 
                                         
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
                                       
Adjustments to the profit or loss items:
                                       
Depreciation
   
3,379
     
2,814
     
1,128
     
874
     
3,703
 
Financial income, net
   
(164
)
   
(665
)
   
(340
)
   
(133
)
   
(1,082
)
Cost of share-based payment
   
987
     
679
     
353
     
294
     
948
 
Taxes on income
   
574
     
(11
)
   
214
     
-
     
(1,955
)
Loss (gain) from sale of property and equipment
   
(2
)
   
70
     
-
     
-
     
55
 
Change in employee benefit liabilities, net
   
97
     
(109
)
   
66
     
(18
)
   
(16
)
     
4,871
     
2,778
     
1,421
     
1,017
     
1,653
 
Changes in asset and liability items:
                                       
                                         
Decrease in trade receivables, net
   
4,408
     
15,346
     
1,806
     
9,929
     
2,311
 
Decrease (increase) in other accounts receivables
   
1,204
     
(179
)
   
955
     
(16
)
   
(1,336
)
Decrease (increase) in inventories
   
(4,715
)
   
(7,864
)
   
1,470
     
(1,561
)
   
(8,246
)
Decrease in deferred expenses
   
333
     
522
     
605
     
91
     
235
 
Decrease in trade payables
   
(4,585
)
   
(6,394
)
   
(6,512
)
   
(4,786
)
   
(1,116
)
Increase (decrease) in other accounts payables
   
379
     
(1,117
)
   
432
     
(141
)
   
(658
)
Decrease in deferred revenues
   
(221
)
   
(3,860
)
   
(95
)
   
(1,286
)
   
(5,256
)
     
(3,197
)
   
(3,546
)
   
(1,339
)
   
2,230
     
(14,066
)
Cash received (paid) during the period for:
                                       
                                         
Interest paid
   
(182
)
   
(42
)
   
(58
)
   
(12
)
   
(54
)
Interest received
   
554
     
451
     
254
     
204
     
739
 
Taxes paid
   
(25
)
   
(17
)
   
(9
)
   
(8
)
   
(22
)
     
347
     
392
     
187
     
184
     
663
 
Net cash provided by operating activities
 
$
18,910
   
$
4,175
   
$
6,092
   
$
1,040
   
$
10,546
 



CONSOLIDATED STATEMENTS OF CASH FLOWS

   
Nine months period Ended
   
Three months period Ended
   
Year Ended
 
   
September, 30
   
September, 30
   
December 31,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
   
U.S Dollars In thousands
 
Cash Flows from Investing Activities
                             
                               
Proceeds of investment in short term investments, net
   
(6,160
)
 
$
(1,747
)
 
$
(1,032
)
 
$
207
   
$
(2,322
)
Purchase of property and equipment and intangible assets
   
(1,488
)
   
(2,033
)
   
(731
)
   
(534
)
   
(2,884
)
Proceeds from sale of property and equipment
   
9
     
15
     
-
     
-
     
30
 
Net cash used in investing activities
   
(7,639
)
   
(3,765
)
   
(1,763
)
   
(327
)
   
(5,176
)
                                         
Cash Flows from Financing Activities
                                       
Proceeds from exercise of share base payments
   
12
     
6
     
3
     
3
     
9
 
Repayment of long-term loans and leases
   
(1,147
)
   
(450
)
   
(386
)
   
(149
)
   
(596
)
Net cash used in financing activities
   
(1,135
)
   
(444
)
   
(383
)
   
(146
)
   
(587
)
                                         
Exchange differences on balances of cash and cash equivalent
   
(780
)
   
224
     
(332
)
   
(52
)
   
629
 
Increase in cash and cash equivalents
   
9,356
     
190
     
3,614
     
515
     
5,412
 
Cash and cash equivalents at the beginning of the period
   
18,093
     
12,681
     
23,835
     
12,356
     
12,681
 
Cash and cash equivalents at the end of the period
   
27,449
   
$
12,871
     
27,449
   
$
12,871
   
$
18,093
 
Significant non-cash transactions
                                       
Purchase of property and equipment through leases
 
$
4,984
   
$
-
   
$
436
   
$
-
   
$
-
 
Purchase of property and equipment
 
$
264
   
$
215
   
$
264
   
$
215
   
$
720
 



ADJUSTED EBITDA
                             
                               
   
Nine months period ended
   
Three months period ended
   
Year ended
 
   
September 30,
   
September 30,
   
December 31,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
In thousands
 
Net income (loss)
 
$
16,889
   
$
4,551
   
$
5,823
   
$
(2,391
)
 
$
22,296
 
Taxes on income
   
574
     
(11
)
   
214
     
-
     
(1,955
)
Financial income, net
   
(164
)
   
(665
)
   
(340
)
   
(133
)
   
(1,082
)
Depreciation
   
3,379
     
2,814
     
1,128
     
874
     
3,703
 
Cost of share  - based payments
   
987
     
679
     
353
     
294
     
948
 
   
$
21,665
   
$
7,368
   
$
7,178
   
$
(1,356
)
 
$
23,910
 

ADJUSTED NET INCOME
                                       
                                         
   
Nine months period ended
   
Three months period ended
   
Year ended
 
   
September 30,
   
September 30,
   
December 31,
 
     
2019
     
2018
     
2019
     
2018
     
2018
 
   
In thousands
 
Net income (loss)
 
$
16,889
   
$
4,551
   
$
5,823
   
$
(2,391
)
 
$
22,296
 
Cost of share  - based payments
   
987
     
679
     
353
     
294
     
948
 
Adjusted net income
 
$
17,876
   
$
5,230
   
$
6,176
   
$
(2,097
)
 
$
23,244