Alpha-antitrypsin(PPL Therapeutics Plc)

REHOVOT, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and 12 months ended December 31, 2020. “We are pleased to have overcome meaningful operational challenges caused by the global COVID-19 pandemic and met our key financial targets for 2020,” said Amir London, Kamada’s Chief Executive Officer. “For full-year 2020, we recorded total revenues of $133.2 million, in-line with our guidance of $132 million to $137 million, and a 5% increase compared to 2019 revenues. These results are indicative of the fundamental strengths of our business." "The acquisition of the Blood and Plasma Research (B&PR) collection center and establishment of our wholly-owned subsidiary, Kamada Plasma LLC, represents our entry into the U.S. plasma collection market, furthers our strategic goal of becoming a fully integrated specialty plasma company, and is expected to improve our IgG competitive pro multiple markets. We intend to significantly expand our hyperimmune plasma collection capacity by investing in this center and leveraging its FDA license to open additional centers in the U.S.," continued Mr. London. "We continue to advance the rapid development and manufacturing of our plasma-derived COVID-19 IgG investigational product, which is being supplied to the Israeli Ministry of Health (IMOH) for the treatment of an estimated 500 hospitalized patients, through an agreement that is expected to generate approximately $3.4 million in revenue to Kamada. We continue to ramp up production of the product using plasma collected by our partner Kedrion Biopharma, in anticipation of a potential expansion of the IMOH supply agreement and possible demand from additional international markets," added Mr. London. “In addition, we continue to develop our pipeline, primarily focusing on the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency and on exploring new strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. Moreover, we intend to leverage our IgG platform technology as a strategic business line, with the ability to respond to future potential pandemic situations,” concluded Mr. London. As previously reported, the transition of Glassia manufacturing to Takeda and the continued uncertainty in the operating environment created by the ongoing global COVID-19 pandemic are expected to result in reduced revenues and profitability in 2021. At the same time, Kamada continues to focus on expanding its existing growth drivers, which include: Continued market share growth for KedRAB in the U.S.; Expanding the sales of Glassia and the Company’s IgG portfolio in ex-U.S. markets, including registration and launch of the products in new territories; Generating royalties from Glassia, projected to be in the range of $10 million to $20 million per year commencing in 2022; Launching nine biosimilar products in the Israeli-based Distribution segment between 2022 and 2025, pending regulatory approval, with estimated maximum sales in the range of $25 million to $35 million; and Leveraging the Company’s plasma-derived products manufacturing facility and expertise to offer contract manufacturing services of specialty IgG products, including an FDA-approved and commercialized IgG product that is expected to add between $8 million to $10 million in annual revenues, beginning in 2023. Financial Highlights for the Three Months Ended December 31, 2020 Total revenues were $31.5 million in the fourth quarter of 2020, a 2% decrease from the $32.1 million recorded in the fourth quarter of 2019. Gross profit was $10.2 million in the fourth quarter of 2020, compared to $12.1 million reported in the fourth quarter of 2019. Net income was $1.6 million, or $0.04 per share, in the fourth quarter of 2020, as compared to net income of $5.4 million, or $0.13 per share, in the fourth quarter of 2019. Adjusted EBITDA, as detailed in the tables below, was $4.0 million in the fourth quarter of 2020, as compared to $6.8 million in the fourth quarter of 2019. Cash provided by operating activities was $12.7 million in the fourth quarter of 2020, as compared to cash provided by operating activities of $8.6 million in the fourth quarter of 2019. Financial Highlights for the Year Ended December 31, 2020 Total revenues were $133.2 million in the year ended December 31, 2020, a 5% increase from the $127.2 million recorded in the year ended December 31, 2019. Gross profit was $47.6 million in the year ended December 31, 2020, compared to $49.7 million in the same period of 2019. Proprietary Product segment gross margins in the year ended December 31, 2020 were 43%, down three percentage points from the year ended December 31, 2019, and in-line with the Company’s expectations of an annual decrease of three to five percentage points, primarily attributable to a change in product sales mix and reduced plant utilization. Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other Expenses, totaled $28.3 million in the year ended December 31, 2020, as compared to $27.0 million in the year ended December 31, 2019. The 4% increase in Research and Development expenses for full-year 2020 as compared to 2019 was below Kamada’s guidance of a 13%-15% year-over-year increase. This is primarily due to the delay in patient enrollment in the Company’s InnovAATe clinical trial due to the impact of the COVID-19 pandemic. Net income was $17.1 million, or $0.38 (fully diluted) per share, in the year ended December 31, 2020, as compared to net income of $22.3 million, or $0.55 per share, in the year ended December 31, 2019. Adjusted EBITDA, as detailed in the tables below, was $25.1 million in the year ended December 31, 2020, as compared to $28.5 million in the year ended December 31, 2019. Cash provided by operating activities was $19.1 million in the year ended December 31, 2020, as compared to cash provided by operating activities of $27.6 million in the year ended December 31,2019. Balance Sheet Highlights As of December 31, 2020, the Company had cash, cash equivalents, and short-term investments of $109.3 million, as compared to $73.9 million on December 31, 2019. This increase was attributable to the issuance and sale of $25 million of equity to FIMI Opportunity Fund, the leading private equity investor in Israel, as well as positive operational cash flow. Recent Corporate Highlights Acquired privately held B&PR’s plasma collection center in Beaumont, TX, which specializes in the collection of hyper-immune plasma used by Kamada in the manufacture of its anti-D products. Began supplying its COVID-19 plasma-derived IgG product to the IMOH for the treatment of COVID-19 patients in Israel; agreement expected to generate approximately $3.4 million in revenue to Kamada. Entered into agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the European Medicines Agency and subsequently by the IMOH, the three products are expected to be launched in Israel between 2022 and 2024 and Kamada estimates the potential collective maximum sales generated by the sale of these three products, achievable following regulatory approval and within several years of launch, to be in the range of $5 million to $7 million annually. Added to the NASDAQ Biotechnology Index® (Nasdaq: NBI) designed to track the performance of a set of either biotechnology or pharmaceutical companies listed on The NASDAQ Stock Market®. Conference Call Kamada management will host an investment community conference call on Wednesday, February 10, 2020, at 8:00am 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.), 1-809-409-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13715277. The call will also be webcast live on the Internet on the Company’s website at . About Kamada Kamada Ltd. (“the Company”) is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed 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. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce Glassia for Takeda through 2021 and Takeda will initiate its own production of Glassia for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company. The Company’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® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company 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. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company’s intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company 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. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares. 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:1) 2020 financial results being indicative of the fundamental strengths of Kamada’s business, 2) benefits of the B&PR acquisition, including furthering Kamada’s strategic goal of becoming a fully integrated specialty plasma company, the acquisition’s ability to improve Kamada’s IgG competitiveness in different markets and ability to expand Kamada’s hyperimmune plasma collection capacity by investing in the acquired center and leveraging its FDA license to open additional centers in the U.S., 3) plasma derived COVID-19 IgG investigational product supplied to the IMOH is estimated to be used to treat 500 hospitalized patient, through an agreement expected to generate approximately $3.4M in revenue to Kamada, 4) raping up of manufacturing of Kamada’s plasma derived COVID-19 immunoglobulin investigational product in anticipation of a potential expansion of the IMOH supply agreement and possible demand from additional international markets, 5) optimism about the pipeline, which is primarily focused on the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency and exploring new strategic business development opportunities that will utilize and expand Kamada’s core plasma-derived development, manufacturing, and commercialization expertise, 6) Kamada’s intention to leverage its IgG platform technology as a strategic business line, with the ability to respond to future potential pandemic situations, 7) expectation to reduced revenues and profitability in 2021 due to the recently reported transition of Glassia manufacturing to Takeda and the continued uncertainty in the operating environment created by the ongoing global COVID-19 pandemic, 8) expectation for a continued increase in KedRAB market share in the U.S., 9) Expansion of sales of Glassia and IgG portfolio in ex-U.S. markets , including the registration and launch of the products in new territories, 10) Glassia’s royalties estimated at a range of $10 Million to $20 Million per year commencing 2022, 11) the nine biosimilar products portfolio in the Israeli-based Distribution segment launching between 2022 and 2025 and estimation for maximum sales in the range of $25 Million to $35 Million, and 12) the leveraging of the Company’s plasma-derived products manufacturing facility and expertise to offer contract manufacturing services of specialty IgG products, including those of an FDA-approved and commercialized IgG product expected to add between $8 Million to $10 Million in annual revenues starting in 2023. 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, the continued evolvement of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, the effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, continued demand for Kamada’s products, including GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the Company’s customer, suppliers and services providers, ability to reap the benefits of the B&PR acquisition, ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to obtain regulatory approval for the nine biosimilar products portfolio, the fruition of the contract manufacturing services of the FDA-approved and commercialized specialty IgG product, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going compassionate-use treatments, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. CONTACTS: Chaime Orlev Chief Financial Officer IR@kamada.com Bob Yedid LifeSci Advisors, LLC 646-597-6989 Bob@LifeSciAdvisors.com CONSOLIDATED BALANCE SHEETS As of December 31, 2020 2019 Assets U.S. Dollars in thousands Current Assets Cash and cash equivalents $ 70,197 $ 42,662 Short-term investments 39,069 31,245 Trade receivables, net 22,108 23,210 Other accounts receivables 4,524 3,272 Inventories 42,016 43,173 Total Current Assets 177,914 143,562 Non-Current Assets Property, plant and equipment, net 25,679 24,550 Right-of-use-assets 3,440 4,022 Other long term assets 1,573 352 Contract asset 2,059 - Deferred taxes - 1,311 Total Non-Current Assets 32,751 30,235 Total Assets $ 210,665 $ 173,797 Liabilities Current Liabilities Current maturities of bank loans $ 238 $ 489 Current maturities of lease liabilities 1,072 1,020 Trade payables 16,110 24,830 Other accounts payables 7,547 5,811 Deferred revenues - 589 Total Current Liabilities 24,967 32,739 Non-Current Liabilities Bank loans 36 257 Lease liabilities 3,593 3,981 Deferred revenues 2,025 232 Employee benefit liabilities, net 1,406 1,269 Total Non-Current Liabilities 7,060 5,739 Shareholder's Equity Ordinary shares 11,706 10,425 Additional paid in capital net 209,760 180,819 Capital reserve due to translation to presentation currency (3,490 ) (3,490 ) Capital reserve from hedges 357 8 Capital reserve from financial assets measured at fair value through other comprehensive Income - 145 Capital reserve from share-based payments 4,558 8,844 Capital reserve from employee benefits (320 ) (359 ) Accumulated deficit (43,933 ) (61,073 ) Total Shareholder’s Equity 178,638 135,319 Total Liabilities and Shareholder’s Equity $ 210,665 $ 173,797 CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME For the year ended Three months period ended December 31, December 31, 2020 2019 2020 2019 U.S. Dollars in thousands, other than per share information Revenues from proprietary products $ 100,916 $ 97,696 $ 23,283 $ 25,175 Revenues from distribution 32,330 29,491 8,259 6,896 Total revenues 133,246 127,187 31,542 32,071 Cost of revenues from proprietary products 57,750 52,425 13,933 14,013 Cost of revenues from distribution 27,944 25,025 7,444 5,969 Total cost of revenues 85,694 77,450 21,377 19,982 Gross profit 47,552 49,737 10,165 12,089 Research and development expenses 13,609 13,059 3,274 3,329 Selling and marketing expenses 4,518 4,370 1,221 929 General and administrative expenses 10,139 9,194 3,006 2,343 Other expenses and (incomes) 49 330 15 3 Operating income 19,237 22,784 2,649 5,485 Financial income 1,027 1,146 162 259 Income (expense) in respect of securities measured at fair value, net 102 (5 ) - (2 ) Income (expense) in respect of currency exchange differences and derivatives instruments, net (1,535 ) (651 ) (839 ) (148 ) Financial expenses (266 ) (293 ) (62 ) (76 ) Income before taxes 18,565 22,981 1,910 5,518 Taxes on income 1,425 730 281 156 Net Income $ 17,140 $ 22,251 1,629 $ 5,362 Other Comprehensive Income (loss) : Amounts that will be or that have been reclassified to profit or loss when specific conditions are met: Gain from securities measured at fair value through other comprehensive income (188 ) 143 - 11 Gain (loss) on cash flow hedges 876 92 360 (7 ) Net amounts transferred to the statement of profit or loss for cash flow hedges (528 ) (23 ) (255 ) (3 ) Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan 64 (388 ) 64 (388 ) Tax effect 19 (11 ) (10 ) 22 Total comprehensive income $ 17,383 $ 22,064 $ 1,788 $ 4,997 Earnings per share attributable to equity holders of the Company: Basic income per share $ 0.39 $ 0.55 $ 0.04 $ 0.13 Diluted income per share $ 0.38 $ 0.55 $ 0.04 $ 0.13 CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended Three months period ended December 31, December 31, 2020 2019 2020 2019 U.S. Dollars in thousands Cash Flows from Operating Activities Net income $ 17,140 $ 22,251 $ 1,629 $ 5,362 Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustments to the profit or loss items: Depreciation and impairment 4,897 4,519 1,265 1,140 Financial income, net 672 (197 ) 739 (33 ) Cost of share-based payment 977 1,163 124 176 Taxes on income 1,425 730 281 156 Gain from sale of property and equipment (7 ) (2 ) - - Change in employee benefit liabilities, net 201 94 208 (3 ) 8,165 6,307 2,617 1,436 Changes in asset and liability items: Decrease (increase) in trade receivables, net 1,332 5,117 6,872 709 Increase in other accounts receivables 115 (214 ) (857 ) (1,418 ) Increase in inventories 1,157 (13,857 ) 602 (9,142 ) Decrease (increase) in Contract asset and deferred expenses (3,085 ) 399 (621 ) 66 Increase (decrease) in trade payables (9,560 ) 6,259 928 10,844 Increase (decrease) in other accounts payables 1,736 863 1,310 484 Decrease in deferred revenues 1,204 (283 ) 14 (62 ) (7,101 ) (1,716 ) 8,248 1,481 Cash received (paid) during the period for: Interest paid (209 ) (243 ) (51 ) (61 ) Interest received 1,211 1,106 320 552 Taxes paid (101 ) (134 ) (14 ) (109 ) 901 729 255 382 Net cash provided by operating activities $ 19,105 $ 27,571 $ 12,749 $ 8,661 CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended Three months period ended December 31, December 31, 2020 2019 2020 2019 U.S. Dollars in thousands Cash Flows from Investing Activities Proceeds of investment in short term investments, net $ (7,646 ) $ 1,727 $ 8,000 $ 7,887 Purchase of property and equipment and intangible assets (5,488 ) (2,300 ) (2,116 ) (812 ) Proceeds from sale of property and equipment 7 9 - - Net cash provided by (used in) investing activities (13,127 ) (564 ) 5,884 7,075 Cash Flows from Financing Activities Proceeds from exercise of share base payments 65 16 4 4 Repayment of lease liabilities (1,103 ) (1,070 ) (288 ) (276 ) Repayment of long-term loans (492 ) (476 ) (119 ) (123 ) Proceeds from issuance of ordinary shares, net 24,894 - - - Net cash used in financing activities 23,364 (1,530 ) (403 ) (395 ) Exchange differences on balances of cash and cash equivalent (1,807 ) (908 ) (520 ) (128 ) Increase in cash and cash equivalents 27,535 24,569 17,710 15,213 Cash and cash equivalents at the beginning of the period 42,662 18,093 52,487 27,449 Cash and cash equivalents at the end of the period $ 70,197 $ 42,662 $ 70,197 $ 42,662 Significant non-cash transactions Purchase of property and equipment through leases $ 539 $ 5,035 $ - $ 51 Purchase of property and equipment $ 722 $ 992 $ 722 $ 992 ADJUSTED EBITDA For the year ended Three months period ended December 31, December 31, 2020 2019 2020 2019 U.S. Dollars in thousands Net income (loss) $ 17,140 $ 22,251 $ 1,629 $ 5,362 Taxes on income 1,425 730 281 156 Financial expense (income), net 672 (197 ) 739 (33 ) Depreciation and amortization expense 4,897 4,519 1,265 1,140 Non-cash share-based compensation expenses 977 1,163 124 176 Adjusted EBITDA $ 25,111 $ 28,466 $ 4,038 $ 6,801 ADJUSTED NET INCOME For the year ended Three months period ended December 31, December 31, 2020 2019 2020 2019 U.S. Dollars in thousands Net income (loss) $ 17,140 $ 22,251 $ 1,629 $ 5,362 Share-based compensation charges 977 1,163 124 176 Adjusted net income $ 18,117 $ 23,414 $ 1,753 $ 5,538