Kamada Reports Strong Second Quarter and First Half 2023 Financial Results; Reiterates 2023 Revenue and Profitability Guidance

2023-08-16

临床3期财报并购生物类似药

Second Quarter 2023 Revenues were $37.4 Million, Representing a 59% Increase Year-over-Year; First Half 2023 Revenues of $68.2 Million, Up 32% Year-over-Year

First Half 2023 Adjusted EBITDA of $9.9 Million, Up 24% Year-over-Year

Robust Second Quarter Results and Positive Outlook for Second Half of 2023 Support Reiteration of Fiscal Year 2023 Revenue Guidance of $138 Million - $146 Million, and Adjusted EBITDA of $22 Million to $26 Million

Extended U.S. Distribution Agreement for KEDRAB® Rabies Immunoglobulin with Kedrion Biopharma Through March 2026

Reports Positive Scientific Advice from European Medicines Agency (EMA) Regarding Ongoing Pivotal Inhaled AAT Study that Reconfirms the Overall Design of the Study and Acknowledges Certain Positive Results Demonstrated in Previously Completed Phase 2/3 Study

Shareholder Vote to Approve $60 Million Private Placement with FIMI Opportunity Funds Scheduled for August 29, 2023

Conference Call and Live Webcast Today at 8:30 AM ET

REHOVOT, Israel and HOBOKEN, N.J., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the three and six months ended June 30, 2023.

“Our strong start to 2023 continued in the second quarter, both financially and operationally,” said Amir London, Kamada’s Chief Executive Officer. “With total revenues for the first six months of the year of $68.2 million, which represented year-over-year growth of 32%, and adjusted EBITDA of $9.9 million, representing 24% growth year-over-year, we achieved the top- and bottom-line growth anticipated in our business during the first six months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase of KEDRAB® sales to Kedrion for further distribution in the U.S., as well as the portfolio of the four FDA-approved Immunoglobulins (CYTOGAM®, HEPAGAMB®, VARIZIG® and WINRHO® SDF), and our Israeli distribution business.”

“Importantly, we expect the momentum in our business to continue through the second half of the year, with full-year profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA of $22 million to $26 million; the mid-point of the range would represent profitability growth of approximately 35% over 2022,” continued Mr. London.

“We continue to advance our pivotal phase 3 InnovAATe trial for Inhaled AAT and recently received positive scientific advice from the European Medicines Agency (EMA) that reconfirmed the overall design of the on-going study and acknowledged the statistically and clinically meaningful improvement in lung function (FEV1) demonstrated in our previous Phase 2/3 European study, which served as the basis for the design and the selection of the primary endpoint of our current pivotal Phase 3 study. Discussion with the FDA regarding study progress will be completed by the end of 2023,” added Mr. London.

“We are actively engaged in seeking shareholders' approval, later this month, for the $60 million share purchase agreement previously signed with FIMI. This strategic investment will provide us with financial flexibility to pursue compelling business development opportunities, a process that we have initiated, and will be further ramped up upon receipt of shareholder approval and closing of the transaction. Additionally, the recent extension through March 2026 of our U.S distribution agreement with Kedrion for KEDRAB assures that this important product will remain a key growth catalyst for Kamada Kamada. We remain in active discussions with Kedrion to potentially further expand the scope of the collaboration,” concluded Mr. London.

Financial Highlights for the Three Months Ended June 30, 2023

Total revenues were $37.4 million in the second quarter of 2023, a 59% increase from the $23.6 million recorded in the second quarter of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased demand for the product in the U.S. market. As a reminder, during the second quarter of 2022, a portion of sales were delayed due to the labor strike at the Company’s manufacturing facility in Israel.

Gross profit and gross margins were $14.4 million and 39%, respectively, in the second quarter of 2023, compared to $7.2 million and 31%, respectively, reported in the second quarter of 2022. Cost of goods sold in the Company’s Proprietary segment included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. As a reminder, gross profit, and gross margin for the second quarter of 2022 were affected by a $3.3 million loss as a result of the labor strike at the Company’s manufacturing facility in Israel.

Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $11.8 million in the second quarter of 2023, as compared to $9.5 million in the second quarter of 2022. S&M costs included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT.

Net income was $1.8 million, or $0.04 per share, in the second quarter of 2023, as compared to a net loss of $3.9 million, or $(0.09) per share, in the second quarter of 2022.

Adjusted EBITDA, as detailed in the tables below, was $6.0 million in the second quarter of 2023, as compared to $1.3 million in the second quarter of 2022. As a reminder, adjusted EBITDA for the second quarter of 2022 was affected by the labor strike related loss. Adjusted EBITDA for the second quarter of 2022, excluding such loss associated with the labor strike, would have been $4.7 million.

Cash provided by operating activities was $1.8 million in the second quarter of 2023, as compared to cash provided by operating activities of $10.9 million in the second quarter of 2022. The change was correlated to the changes in the Company’s working capital.

Financial Highlights for the Six Months Ended June 30, 2023

Total revenues for the first six months of 2023 were $68.2 million, a 32% increase from the $51.7 million generated in the first six months of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased demand for the product in the U.S. market.

Gross profit and gross margins for the first six months of 2023 were $26.3 million and 39%, respectively, compared to $18.5 million and 36%, respectively, in the first half of 2022. Cost of goods sold in the Company’s Proprietary segment included $2.7 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. As a reminder, gross profit, and gross margin for the first six months of 2022 were affected by a $3.3 million loss as a result of the labor strike at the Company’s manufacturing facility in Israel.

Operating expenses, including R&D, S&M, G&A and other expenses, totaled $23.4 million in the first six months of 2023, as compared to $20.6 million in the first half of 2022. S&M costs included $0.8 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT.

Net profit for the first six months of 2023 was $3,000, or less than one cent per share, as compared to net loss of $5.7 million, or $(0.13) per share, in the prior year period.

Adjusted EBITDA, as detailed in the tables below, was $9.9 million in the first six months of 2023, as compared to $4.6 million in the first six months of 2022. As a reminder, adjusted EBITDA for the first six months of 2022 were affected by a $3.3 million loss as result of the labor strike at the Company’s manufacturing facility in Israel. The adjusted EBITDA for the first six months of 2023 represented a 24% increase compared to the adjusted EBITDA excluding labor strike related loss for the first six months of 2022.

Cash used in operating activities during the first six months of 2023 was approximately $1.0 million, as compared to cash provided by operating activities of $16.4 million during the first six months of 2022.The change was correlated to the changes in the Company’s working capital.

Balance Sheet Highlights

As of June 30, 2023, the Company had cash, cash equivalents, and short-term investments of $21.8 million, as compared to $34.3 million as of December 31, 2022. This figure does not include the expected net proceeds from the recently announced $60 million financing, which is expected to close, subject to shareholders' vote, during the third quarter of 2023.

Recent Corporate Highlights

Announced that Kedrion exercised its option to extend through March 2026 the KEDRAB distribution agreement.

Fiscal Year 2023 Guidance

Kamada continues to expect to generate fiscal year 2023 total revenues in the range of $138 million to $146 million. The Company also continues to anticipate generating adjusted EBITDA during 2023 in the range of $22 million to $26 million, the mid-point of the range would represent profitability growth of approximately 35% over 2022.

Conference Call

Kamada management will host an investment community conference call on Wednesday, August 16, 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 1-877-407-0792 (from within the U.S.), 1 809-406-247 (from Israel), or 1 201-689-8263 (International) and entering the conference identification number: 13740401. The call will also be webcast live on the Internet at:

https://viavid.webcasts.com/starthere.jsp?ei=1626943&tp_key=6e37fa90e3.

Non-IFRS financial measures

We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.

About Kamada

Kamada Ltd. (the “Company”) is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm 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) Expectation that the momentum in our business to continue through the second half of the year, with profitability to be further meaningfully enhanced as compared to last year; (2) 2023 revenue guidance in the range of $138 Million to $146 Million; (3) 2023 adjusted EBITDA to be in the range of $22 million to $26 million, with the mid-point of the range representing profitability growth of approximately 35% over 2022; (4) Discussion with the FDA regarding study progress to be completed by the end of 2023; (5) Potential expansion of the scope of the collaboration between Kamada and Kedrion; (6) effectively leveraging multiple growth drivers, including significant increase of KEDRAB sales to Kedrion, the portfolio of four FDA approved IgGs acquired in late 2021, the sales of our other Proprietary products in the international markets, and our Israeli distribution business; (7) shareholder approval and expected closing of the recently announced $60 million financing in the third quarter of 2023; (8) The financing providing the Company with financial flexibility, allowing the Company to accelerate the growth of its existing business and pursue compelling business development opportunities; and (9) Optimism about AATD Phase 3 clinical trial progress, including preliminary outcome from EMA discussions. 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 continuation of inbound and outbound international delivery routes, continued demand for Kamada’s products, financial conditions of the Company’s customer, suppliers and services providers, Kamada’s ability to integrate the new product portfolio into its current product portfolio, Kamada’s ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the recent acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial in new locations, unexpected results of clinical studies, 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, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. 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

Brian Ritchie

LifeSci Advisors, LLC

(212) 915-2578

britchie@LifeSciAdvisors.com

KAMADA LTD.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As of June 30, As of

December 31, 2023 2022 2022 Unaudited Audited U.S Dollars in thousands Assets Current Assets Cash and cash equivalents $21,788 $29,933 $34,258 Trade receivables, net 24,581 17,738 27,252 Other accounts receivables 3,077 6,410 8,710 Inventories 80,237 64,520 68,785 Total Current Assets 129,683 118,601 139,005 Non-Current Assets Property, plant and equipment, net 26,936 25,914 26,157 Right-of-use assets 5,517 2,810 2,568 Intangible assets, Goodwill and other long-term assets 143,986 150,449 147,072 Contract assets 8,267 6,361 7,577 Total Non-Current Assets 184,706 185,534 183,374 Total Assets $314,389 $304,135 $322,379 Liabilities Current Liabilities Current maturities of bank loans $4,444 $4,449 $4,444 Current maturities of lease liabilities 1,063 1,010 1,016 Current maturities of other long term liabilities 25,077 20,117 29,708 Trade payables 27,969 17,954 32,917 Other accounts payables 7,235 6,110 7,585 Deferred revenues 38 40 35 Total Current Liabilities 65,826 49,680 75,705 Non-Current Liabilities Bank loans 10,741 15,185 12,963 Lease liabilities 4,972 2,492 2,177 Contingent consideration 19,028 23,121 17,534 Other long-term liabilities 36,514 41,304 37,308 Deferred revenues 0 15 - Employee benefit liabilities, net 556 764 672 Total Non-Current Liabilities 71,811 82,881 70,654 Shareholder’s Equity Ordinary shares 11,737 11,731 11,734 Additional paid in capital net 210,727 210,319 210,495 Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)Capital reserve from hedges (67) (442) (88)Capital reserve from share-based payments 5,902 5,097 5,505 Capital reserve from employee benefits 424 271 348 Accumulated deficit (48,481) (51,912) (48,484)Total Shareholder’s Equity 176,752 171,574 176,020 Total Liabilities and Shareholder’s Equity $314,389 $304,135 $322,379

KAMADA LTD.

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

Six months period ended Three months period ended Year ended June 30, June 30, December 31, 2023 2022 2023 2022 2022 Unaudited Unaudited Audited U.S Dollars in thousands Revenues from proprietary products $55,001 $41,618 $30,940 $18,607 $102,598 Revenues from distribution 13,152 10,065 6,503 4,983 26,741 Total revenues 68,153 51,683 37,443 23,590 129,339 Cost of revenues from proprietary products 30,416 24,705 17,192 12,256 58,229 Cost of revenues from distribution 11,462 8,436 5,815 4,094 24,407 Total cost of revenues 41,878 33,141 23,007 16,350 82,636 Gross profit 26,275 18,542 14,436 7,240 46,703 Research and development expenses 7,514 7,063 4,283 2,643 13,172 Selling and marketing expenses 7,862 6,592 3,940 3,271 15,284 General and administrative expenses 6,902 6,316 3,484 3,311 12,803 Other expenses 1,077 619 98 309 912 Operating income (loss) 2,920 (2,048) 2,631 (2,294) 4,532 Financial income 25 3 - 1 91 Income (expenses) in respect of currency exchange differences and derivatives instruments, net 173 593 22 424 298 Financial Income (expense) in respect of contingent consideration and other long- term liabilities. (2,070) (3,875) (309) (1,865) (6,266)Financial expenses (939) (372) (439) (178) (914)Income (expense) before tax on income 109 (5,699) 1,905 (3,912) (2,259)Taxes on income 106 50 93 9 62 Net Income (loss) $3 $(5,749) $1,812 $(3,921) $(2,321) Other Comprehensive Income (loss) : Amounts that will be or that have been reclassified to profit or loss when specific conditions are met: Gain (loss) on cash flow hedges (244) (784) (88) (676) (776)Net amounts transferred to the statement of profit or loss for cash flow hedges 265 288 120 222 634 Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan 76 420 (115) 420 497 Tax effect - - - - - Total comprehensive income (loss) $100 $(5,825) $1,729 $(3,955) $(1,966) Earnings per share attributable to equity holders of the Company: Basic net earnings per share $0.00 $(0.13) $0.04 $(0.09) $(0.05)Diluted net earnings per share $0.00 $(0.13) $0.04 $(0.09) $(0.05)

KAMADA LTD.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Six months period Ended Three months period Ended Year Ended June, 30 June, 30 December 31, 2023 2022 2023 2022 2022 Unaudited Audited U.S Dollars In thousands Cash Flows from Operating Activities Net income (loss) $3 $(5,749) $1,812 $(3,921) $(2,321) Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustments to the profit or loss items: Depreciation and impairment 6,327 6,088 3,204 3,061 12,155 Financial expenses (income), net 2,811 3,651 726 1,618 6,791 Cost of share-based payment 629 569 214 376 1,153 Taxes on income 106 50 93 9 62 Loss (gain) from sale of property and equipment (5) - - - - Change in employee benefit liabilities, net (40) (96) (32) (84) (111) 9,828 10,262 4,205 4,980 20,050 Changes in asset and liability items: Decrease (increase) in trade receivables, net 2,696 17,102 (3,610) 3,610 7,603 Decrease (increase) in other accounts receivables 1,539 2,073 177 1,484 (578)Decrease (increase) in inventories (11,452) 2,903 (482) 241 (1,361)Decrease (increase) in deferred expenses 3,042 (484) (512) (374) (1,340)Increase (decrease) in trade payables (5,436) (7,843) 1,276 5,806 7,055 Increase (decrease) in other accounts payables (408) (1,517) (170) (745) 290 Decrease in deferred revenues 3 - (381) - (20) (10,016) 12,234 (3,702) 10,022 11,649 Cash received (paid) during the period for: Interest paid (744) (380) (403) (186) (853)Interest received 25 3 0 1 97 Taxes paid (112) (18) (94) (9) (36) (831) (395) (497) (194) (792) Net cash provided by (used in) operating activities $(1,016) $16,352 $1,818 $10,887 $28,586

KAMADA LTD.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Six months period Ended Three months period Ended Year Ended June, 30 June, 30 December 31, 2023 2022 2023 2022 2022 Unaudited Audited U.S Dollars In thousands Cash Flows from Investing Activities Purchase of property and equipment and intangible assets $(2,147) $(1,191) $(1,048) $(678) $(3,784)Proceeds from sale of property and equipment 6 - - - - Business combination - - - - - Net cash provided by (used in) investing activities (2,141) (1,191) (1,048) (678) (3,784) Cash Flows from Financing Activities Proceeds from exercise of share base payments 3 6 2 3 9 Receipt of long-term loans - - - - - Repayment of lease liabilities (517) (573) (246) (278) (1,098)Repayment of long-term loans (2,222) (401) (1,111) (385) (2,628)Repayment of other long-term liabilities (6,000) (3,243) (4,500) (1,743) (5,626)Net cash provided by (used in) financing activities (8,736) (4,211) (5,855) (2,403) (9,343) Exchange differences on balances of cash and cash equivalent (577) 396 (248) 160 212 Increase (decrease) in cash and cash equivalents (12,470) 11,346 (5,333) 7,966 15,671 Cash and cash equivalents at the beginning of the period 34,258 18,587 27,121 21,967 18,587 Cash and cash equivalents at the end of the period $21,788 $29,933 $21,788 $29,933 $34,258 Significant non-cash transactions Right-of-use asset recognized with corresponding lease liability $3,585 $296 $5 $121 $551 Purchase of property and equipment and Intangible assets $840 $775 $840 $775 $618

KAMADA LTD.

NON-IFRS MEASURES – ADJUSTED EBITDA

Six months period ended Three months period ended Year ended June 30, June 30, December 31, 2023 2022 2023 2022 2022 In thousands Net income $3 $(5,749) $1,812 $(3,921) $(2,321)Taxes on income 106 50 93 9 62 Financial expense (income), net 2,811 3,651 726 1,618 6,791 Depreciation and amortization expense 6,327 6,088 3,204 3,202 12,155 Non-cash share-based compensation expenses 629 569 214 414 1,153 Adjusted EBITDA $9,876 $4,639 $6,049 $1,322 $17,840