EX-99.1 2 ea020468001ex99-1_kamada.htm KAMADA REPORTS STRONG FIRST QUARTER 2024 FINANCIAL RESULTS WITH YEAR-OVER-YEAR TOP-LINE GROWTH OF 23% AND A 96% INCREASE IN PROFITABILITY; RAISES FULL-YEAR FINANCIAL GUIDANCE

Exhibit 99.1

 

Kamada Reports Strong First Quarter 2024 Financial Results with Year-Over-Year Top-Line Growth of 23% and a 96% Increase in Profitability; Raises Full-Year Financial Guidance

 

Revenues for First Quarter of 2024 were $37.7 Million, Representing a 23% Increase Year-over-Year

 

First Quarter 2024 Adjusted EBITDA of $7.5 Million, Representing a 96% Increase Year-over-Year

 

Momentum Primarily Driven by U.S. Sales of the Company’s Two Most Significant Catalysts, KEDRAB® and CYTOGAM®

 

Strong First Quarter Results and Positive Outlook for Remainder of 2024 Support Increase of Full-Year Revenue Guidance to $158 Million-$162 Million and Adjusted EBITDA to $28 Million-$32 Million

 

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

 

REHOVOT, Israel, and Hoboken, NJ – May 8, 2024 -- 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 three months ended March 31, 2024.

 

“We are excited by our strong financial and operational start to 2024, which has us well-positioned for a highly successful year,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues for the first quarter of 2024 were $37.7 million, representing a 23% increase year-over-year, and adjusted EBITDA was $7.5 million, nearly double as compared to the first quarter of last year and representing a 20% margin of revenues. While we benefit from the strength of our entire portfolio, we continue to effectively leverage the two most important growth drivers in our business, KEDRAB® and CYTOGAM®. For CYTOGAM, our active promotion of the product, supported by recently published new clinical data, is driving increased demand, and we are encouraged by the continued growth being demonstrated by KEDRAB.”

 

“Based on our strong performance in the first quarter and our expectation for the continued momentum in our business throughout 2024, we are raising our full-year 2024 revenue guidance to be between $158 million to $162 million from the previous forecast of $156 million to $160 million. We are also increasing our adjusted EBITDA guidance to $28 million to $32 million from the initial guidance of $27 million to $30 million. Importantly, we continue to pursue compelling new business development opportunities, leveraging our overall financial strength. These opportunities are expected to support continued growth at double-digit rates beyond 2024,” added Mr. London.

 

“Patient enrollment continues in our ongoing pivotal Phase 3 InnovAATe clinical trial for the inhaled Alpha-1 Antitrypsin therapy for the treatment of AAT Deficiency. Following recent positive feedback from the U.S. Food and Drug Administration (FDA) through which the FDA expressed its willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, we recently filed an IND amendment with both a revised Statistical Analysis Plan (SAP) and study protocol, and we expect further FDA feedback during the second half of 2024. If approved, these changes may allow for the acceleration of the program,” concluded Mr. London.

 

 

 

Financial Highlights for the Three Months Ended March 31, 2024

 

Total revenues were $37.7 million in the first quarter of 2024, a 23% increase from the prior year period. The increase in revenues was primarily attributable to increased sales of CYTOGAM due to increased demand for the product in the U.S. market, as well as increased sales of KEDRAB to Kedrion due to increased market share in the U.S.

 

Gross profit and gross margins were $16.8 million and 44%, respectively, in the first quarter of 2024, compared to $11.9 million and 39%, respectively, reported in the prior year period. Cost of goods sold in the Company’s Proprietary segment for each of the first quarter of 2024 and 2023 included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition.

 

Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $12.7 million in the first quarter of 2024, as compared to $11.6 million in the first quarter of 2023. S&M costs for the first quarter of 2024 and 2023 included $0.4 million of amortization expenses of intangible assets generated through the IgG products acquisition.

 

Net income was $2.4 million, or $0.04 per share, in the first quarter of 2024, as compared to a net loss of $1.8 million, or $(0.04) per share, in the first quarter of 2023.

 

Adjusted EBITDA, as detailed in the tables below, was $7.5 million in the first quarter of 2024, a 96% increase from the $3.8 million in the first quarter of 2023.

 

Cash provided by operating activities was $1.0 million in the first quarter of 2024, as compared to cash used in operating activities of $2.9 million in the first quarter of 2023.

 

Balance Sheet Highlights

 

As of March 31, 2024, the Company had cash, cash equivalents, and short-term investments of $48.2 million, as compared to $55.6 million on December 31, 2023. The decrease in cash balance was attributable to capital investments made with respect to the construction of our new plasma collection center in Uvalde, Texas, and payment on account of long-term liabilities associated with the acquisition completed in November 2021.

 

Recent Corporate Highlights

 

During the first quarter of 2024, Kamada completed the successful launch in Israel of BEVACIZUMAB KAMADA, the biosimilar to Avastin®, which is indicated for the treatment of certain types of cancer, including colon cancer and metastatic breast cancer. This represents the first biosimilar product to be launched and distributed by Kamada in Israel. The product is manufactured by mAbxience Research S.L., from Madrid, Spain.

 

Fiscal Year 2024 Guidance

 

Based on the Company’s strong performance in the first quarter and its expectation for continued momentum in the business throughout 2024, Kamada is increasing its fiscal year 2024 total revenue guidance from a range of $156 million to $160 million to a range of $158 million to $162 million, and adjusted EBITDA from a range of $27 million to $30 million to a range of $28 million to $32 million, representing double digit top- and bottom-line growth year-over-year.

 

Conference Call

 

Kamada management will host an investment community conference call today, Wednesday, May 8, 2024, at 8:30am Eastern Time to present the Company’s results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (from within the U.S.) or 1-809-468-221 (from Israel), or 1-416-764-8658 (International) and entering the conference ID 31202863. The call will also be webcast live on the Internet at https://viavid.webcasts.com/starthere.jsp?ei=1665369&tp_key=952bd14ce0

 

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Non-IFRS financial measures

 

We present EBITDA and adjusted EBITDA because we use these non-IFRS financial measures 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 these non-IFRS financial measures 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 is 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, whereas adjusted EBITDA is the EBITDA plus non-cash share-based compensation expenses and certain other costs.

 

For the projected 2024 adjusted EBITDA information presented herein, the Company is unable to provide a reconciliation of this forward measure to the most comparable IFRS financial measure because the information for these measures is dependent on future events, many of which are outside of the Company’s control.  Additionally, estimating such forward-looking measures and providing a meaningful reconciliation consistent with the Company’s accounting policies for future periods is meaningfully difficult and requires a level of precision that is unavailable for these future periods and cannot be accomplished without unreasonable effort.  Forward-looking non-IFRS measures are estimated in a manner consistent with the relevant definitions and assumptions noted in the Company’s adjusted EBITDA for historical periods.

 

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, the 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), KARAB and KEDRAB. 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 controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

 

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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) positive outlook for reminder of 2024, 2)  anticipation of continued momentum through 2024 and continued growth at double-digit rates beyond 2024, 3) Full-Year Revenue Guidance to be between $158 Million-$162 Million and Adjusted EBITDA to be between $28 Million-$32 Million, 4) being well-positioned for a highly successful year, 5) continuing to maintain the overall financial strength supporting us in pursuing compelling new business development opportunities which would accelerate the growth and profitability of our existing business beyond 2024, 6) continued enrollment in pivotal phase 3 InnovAATe clinical trial, and 7) our expectations to receive FDA feedback to the IND amendment during the second half of 2024, which, if approved, may allow for the acceleration of the InnovAATe program. 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 evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, 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 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, 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

 

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CONDENCED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITTION

 

   As of   As of 
   March 31,   December 31, 
   2024   2023   2023 
   Unaudited   Audited 
             
Assets            
Current Assets            
Cash and cash equivalents  $48,194   $27,121   $55,641 
Trade receivables, net   18,855    20,925    19,877 
Other accounts receivables   6,411    3,603    5,965 
Inventories   84,348    79,754    88,479 
Total Current Assets   157,808    131,403    169,962 
                
Non-Current Assets               
Property, plant and equipment, net   30,727    26,496    28,224 
Right-of-use assets   7,632    5,836    7,761 
Intangible assets, Goodwill and other long-term assets   138,623    145,305    140,465 
Contract assets   8,384    7,755    8,495 
Total Non-Current Assets   185,366    185,392    184,945 
Total Assets  $343,174   $316,795   $354,907 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $-   $4,444   $- 
Current maturities of lease liabilities   1,467    1,438    1,384 
Current maturities of other long-term liabilities   12,980    29,414    14,996 
Trade payables   16,492    26,210    24,804 
Other accounts payables   6,210    7,350    8,261 
Deferred revenues   26    419    148 
Total Current Liabilities   37,175    69,275    49,593 
                
Non-Current Liabilities               
Bank loans   -    11,852    - 
Lease liabilities   7,278    4,992    7,438 
Contingent consideration   16,760    18,115    18,855 
Other long-term liabilities   34,842    37,280    34,379 
Employee benefit liabilities, net   609    473    621 
Total Non-Current Liabilities   59,489    72,712    61,293 
                
Shareholder’s Equity               
Ordinary shares   15,022    11,736    15,021 
Additional paid in capital  net   266,183    210,665    265,848 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   12    (99)   140 
Capital reserve from share-based payments   6,336    5,750    6,427 
Capital reserve from employee benefits   282    539    275 
Accumulated deficit   (37,835)   (50,293)   (40,200)
Total Shareholder’s Equity   246,510    174,808    244,021 
Total Liabilities and Shareholder’s Equity  $343,174   $316,795   $354,907 

 

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CONDENCED CONSOLIDATED INTERIM OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

 

   Three months period ended   Year ended 
   March 31,   December 31, 
   2024   2023   2023 
   Unaudited   Audited 
             
Revenues from proprietary products  $33,758   $24,061   $115,458 
Revenues from distribution   3,978    6,649    27,061 
                
Total revenues   37,736    30,710    142,519 
                
Cost of revenues from proprietary products   17,620    13,224    63,342 
Cost of revenues from distribution   3,365    5,647    23,687 
                
Total cost of revenues   20,985    18,871    87,029 
                
Gross profit   16,751    11,839    55,490 
                
Research and development expenses   4,295    3,231    13,933 
Selling and marketing expenses   4,631    3,922    16,193 
General and administrative expenses   3,786    3,418    14,381 
Other expenses   -    979    919 
Operating income (loss)   4,039    289    10,064 
                
Financial income   280    25    588 
Income (expenses) in respect of currency exchange differences and derivatives instruments, net   124    151    55 
Financial Income (expense) in respect of contingent consideration and other long- term liabilities.   (1,845)   (1,761)   (980)
Financial expenses   (159)   (500)   (1,298)
Income before tax on income   2,439    (1,796)   8,429 
Taxes on income   74    13    145 
                
Net Income (loss)  $2,365   $(1,809)  $8,284 
                
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   (71)   (156)   (186)
Net amounts transferred to the statement of profit or loss for cash flow hedges   (57)   145    414 
Items that will not be reclassified to profit or loss in subsequent periods:               
Remeasurement gain (loss) from defined benefit plan   7    191    (73)
Total comprehensive income (loss)  $2,244   $(1,629)  $8,439 
                
Earnings per share attributable to equity holders of the Company:               
Basic net earnings per share  $0.04   $(0.04)  $0.17 
Diluted net earnings per share  $0.04   $(0.04)  $0.15 

 

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CONDENCED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

 

   Three months period Ended   Year Ended 
   March 31,   December 31, 
   2024   2023   2023 
   Unaudited   Audited 
             
Cash Flows from Operating Activities            
Net income (loss)  $2,365   $(1,809)  $8,284 
                
Adjustments to reconcile net income to net cash provided by (used in) operating activities:               
                
Adjustments to the profit or loss items:               
                
Depreciation and amortization   3,237    3,123    12,714 
Financial expenses (income), net   1,600    2,085    1,635 
Cost of share-based payment   241    415    1,314 
Taxes on income   74    13    145 
Loss (gain) from sale of property and equipment   -    (22)   (5)
Change in employee benefit liabilities, net   (4)   (8)   (125)
    5,148    5,606    15,678 
Changes in asset and liability items:               
                
Decrease (increase) in trade receivables, net   610    6,306    7,835 
Decrease (increase) in other accounts receivables   (516)   1,362    (1,150)
Decrease (increase) in inventories   4,131    (10,970)   (19,694)
Decrease (increase) in deferred expenses   112    3,554    2,814 
Decrease (increase) in trade payables   (8,785)   (6,712)   (8,885)
Decrease (increase)  in other accounts payables   (2,051)   (238)   765 
Decrease (increase) in deferred revenues   (122)   384    113 
    (6,621)   (6,314)   (18,202)
Cash received (paid) during the period for:               
                
Interest paid   (129)   (341)   (1,228)
Interest received   280    25    - 
Taxes paid   (23)   (18)   (217)
    128    (334)   (1,445)
                
Net cash provided by (used in) operating activities  $1,020   $(2,851)  $4,315 

 

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CONDENCED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (continued)

 

   Three months period Ended   Year Ended 
   March 31,   December 31, 
   2024   2023   2023 
   Unaudited   Audited 
             
Cash Flows from Investing Activities               
Purchase of property and equipment and intangible assets  $(2,682)  $(1,117)  $(5,850)
Proceeds from sale of property and equipment   -    24    7 
Net cash provided by (used in) investing activities   (2,682)   (1,093)   (5,843)
                
Cash Flows from Financing Activities               
                
Proceeds from exercise of share base payments   1    1    4 
Proceeds from issuance of ordinary shares, net   -    -    58,231 
Repayment of lease liabilities   (244)   (271)   (850)
Repayment of long-term loans   -    (1,111)   (17,407)
Repayment of other long-term liabilities   (5,496)   (1,500)   (17,300)
Net cash provided by (used in) financing activities   (5,739)   (2,881)   22,678 
                
Exchange differences on balances of cash and cash equivalent   (46)   (312)   233 
                
Increase (decrease) in cash and cash equivalents   (7,447)   (7,137)   21,383 
                
Cash and cash equivalents at the beginning of the period   55,641    34,258    34,258 
                
Cash and cash equivalents at the end of the period  $48,194   $27,121   $55,641 
                
Significant non-cash transactions               
Right-of-use asset recognized with corresponding lease liability  $306   $3,580   $6,546 
Purchase of property and equipment and Intangible assets  $905   $292   $646 

 

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NON-IFRS MEASURES – ADJUSTED EBITDA

 

   Three months period Ended   Year ended 
   March 31,   December 31, 
   2024   2023   2023 
   U.S. Dollars in thousands 
Net (loss) income  $2,365   $(1,809)  $8,284 
Taxes on income   74    13    145 
Financial expense (income), net   1,600    2,085    1,635 
Depreciation and amortization expense   3,237    3,123    12,714 
Non-cash share-based compensation expenses   241    415    1,314 
Adjusted EBITDA  $7,517   $3,827   $24,092 

 

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