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Kamada .(KMDA) - 2022 Q2 - Earnings Call Transcript
2022-08-17 17:58
Kamada Ltd. (NASDAQ:KMDA) Q2 2022 Earnings Conference Call August 17, 2022 8:30 AM ET Company Representatives Amir London - Chief Executive Officer Chaime Orlev - Chief Financial Officer Bob Yedid - LifeSci Advisors Conference Call Participants Anthony Petrone - Mizuho Group Operator Greetings, and welcome to the Kamada Ltd., Second Quarter 2022 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. ...
Kamada .(KMDA) - 2022 Q2 - Quarterly Report
2022-08-17 11:00
Consolidated Financial Statements [Consolidated Statements of Financial Position](index=2&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) Kamada Ltd. reported total assets of **$304.1 million** as of June 30, 2022, a decrease from **$318.7 million** at year-end 2021, with liabilities at **$132.6 million** and equity at **$171.6 million** | Financial Item | June 30, 2022 (Unaudited, in thousands) | Dec 31, 2021 (Audited, in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | **Total Current Assets** | $118,601 | $130,044 | -$11,443 | | **Total Non-Current Assets** | $185,534 | $188,623 | -$3,089 | | **Total Assets** | **$304,135** | **$318,667** | **-$14,532** | | **Total Current Liabilities** | $49,680 | $54,057 | -$4,377 | | **Total Non-Current Liabilities** | $82,881 | $87,786 | -$4,905 | | **Total Liabilities** | **$132,561** | **$141,843** | **-$9,282** | | **Total Shareholder's Equity** | **$171,574** | **$176,824** | **-$5,250** | [Consolidated Statements of Profit or Loss and Other Comprehensive Income](index=3&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2022, revenues rose to **$51.7 million**, but increased operating expenses resulted in an operating loss of **$2.0 million** and a net loss of **$5.7 million** | Metric (Six months ended June 30) | 2022 (Unaudited, in thousands) | 2021 (Unaudited, in thousands) | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $51,683 | $49,139 | +5.2% | | **Gross Profit** | $18,542 | $18,003 | +3.0% | | **Operating Income (Loss)** | ($2,048) | $3,410 | -160.1% | | **Net Income (Loss)** | ($5,749) | $3,624 | -258.6% | | **Basic Net Earnings Per Share** | ($0.13) | $0.08 | -262.5% | [Consolidated Statements of Changes in Equity](index=4&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Equity) Total shareholder's equity decreased by **$5.3 million** during the first six months of 2022, from **$176.8 million** to **$171.6 million**, primarily due to a **$5.7 million** net loss | Equity Component (Six months ended June 30, 2022) | Amount (in thousands) | | :--- | :--- | | **Balance as of January 1, 2022** | **$176,824** | | Net Loss | ($5,749) | | Other Comprehensive Loss | ($76) | | Exercise of share-based payment | $6 | | Cost of share-based payment | $569 | | **Balance as of June 30, 2022** | **$171,574** | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2022, operating activities generated **$16.4 million** in cash, a significant improvement, resulting in an overall **$11.3 million** increase in cash and cash equivalents | Cash Flow Activity (Six months ended June 30) | 2022 (Unaudited, in thousands) | 2021 (Unaudited, in thousands) | | :--- | :--- | :--- | | **Net cash provided by (used in) operating activities** | $16,352 | ($1,178) | | **Net cash provided by (used in) investing activities** | ($1,191) | $100 | | **Net cash provided by (used in) financing activities** | ($4,211) | ($791) | | **Increase (decrease) in cash and cash equivalents** | $11,346 | ($1,781) | | **Cash and cash equivalents at end of period** | $29,933 | $68,416 | [Notes to the Interim Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed context for the financial statements, outlining business activities, accounting policies, key events, segment performance, financial instruments, and subsequent events [Note 1: General](index=12&type=section&id=Note%201%3A%20General) Kamada is a global biopharmaceutical company focused on plasma-derived therapeutics, strategically expanding its U.S. commercial presence and transitioning its GLASSIA agreement with Takeda to a royalty model - The company's strategy focuses on profitable growth from its commercial portfolio of specialty plasma-derived therapeutics and its manufacturing and development expertise[15](index=15&type=chunk) - In November 2021, Kamada acquired a portfolio of four FDA-approved plasma-derived products from Saol Therapeutics to strengthen its U.S. commercial capabilities[16](index=16&type=chunk) - Effective 2022, the company's agreement with Takeda for GLASSIA transitioned to a royalty-based model. Kamada will receive a **12% royalty** on net sales through August 2025, and **6% thereafter until 2040**, with a minimum of **$5 million annually**[17](index=17&type=chunk) [Note 2: Significant Accounting Policies](index=13&type=section&id=Note%202%3A%20Significant%20Accounting%20Policies) Interim consolidated financial statements are prepared under IAS 34, noting upcoming IAS 1 and IAS 12 amendments effective January 1, 2023, with impacts largely unassessed or not expected to affect statements - The financial statements have been prepared in accordance with **IAS 34** for interim periods[19](index=19&type=chunk) - An amendment to **IAS 1** regarding the classification of liabilities as current or non-current is effective January 1, 2023, but the company believes it will not have an effect on its financial statements[20](index=20&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk) - An amendment to **IAS 12** regarding deferred tax on assets and liabilities from a single transaction is effective January 1, 2023. The company has not yet commenced examining its effects[22](index=22&type=chunk)[24](index=24&type=chunk) [Note 3: Significant events in the reporting period](index=14&type=section&id=Note%203%3A%20Significant%20events%20in%20the%20reporting%20period) Key events include a significant stock option grant, a labor strike at Beit Kama resulting in a **$3.34 million** loss, and a **$420 thousand** reduction in employee benefit liability due to bond yield increases - On February 28, 2022, the Board approved the grant of options to purchase up to **1,345,600 shares** for employees/officers, **400,000** for the CEO, and **270,000** for Board members[25](index=25&type=chunk) - A labor strike at the Beit Kama production facility, which began on April 26, 2022, resulted in a loss of **$3.34 million** during the second quarter, recorded in the cost of revenues from proprietary products[28](index=28&type=chunk)[29](index=29&type=chunk) - An increase in the yield of high-quality corporate bonds led to a change in the discount rate, reducing the employee benefit liability by **$420 thousand**, which was recognized in other comprehensive income[29](index=29&type=chunk)[30](index=30&type=chunk) [Note 4: Operating Segments](index=15&type=section&id=Note%204%3A%20Operating%20Segments) The company operates in Proprietary Products and Distribution segments, with Proprietary Products generating **$41.6 million** revenue and **$16.9 million** gross profit, and the U.S.A. and North America as the largest market | Segment (Six months ended June 30, 2022) | Revenues (in thousands) | Gross Profit (in thousands) | | :--- | :--- | :--- | | **Proprietary Products** | $41,618 | $16,913 | | **Distribution** | $10,065 | $1,629 | | **Total** | **$51,683** | **$18,542** | | Geographic Region (Six months ended June 30, 2022) | Revenues (in thousands) | | :--- | :--- | | **U.S.A and North America** | $28,562 | | **Israel** | $12,319 | | **Europe** | $5,149 | | **Latin America** | $3,526 | | **Asia** | $1,760 | | **Others** | $367 | | **Total** | **$51,683** | [Note 5: Financial Instruments](index=19&type=section&id=Note%205%3A%20Financial%20Instruments) As of June 30, 2022, derivative instruments with a **$437 thousand** fair value liability are Level 2, and contingent consideration with a **$23.1 million** liability is Level 3 in the fair value hierarchy | Financial Instrument (June 30, 2022) | Fair Value (in thousands) | Hierarchy Level | | :--- | :--- | :--- | | Derivatives instruments | ($437) | Level 2 | | Contingent consideration | ($23,121) | Level 3 | [Note 6: Subsequent events](index=19&type=section&id=Note%206%3A%20Subsequent%20events) The Beit Kama labor strike ended on July 15, 2022, with a new agreement, and a terminated distributor initiated a conciliation hearing on July 18, 2022, seeking damages, with unassessable prospects - The labor strike at the Beit Kama manufacturing plant ended following the signing of a new collective agreement on **July 15, 2022**[28](index=28&type=chunk)[38](index=38&type=chunk) - On **July 18, 2022**, an affiliate of a terminated distributor for Russia and Ukraine filed a request for a conciliation hearing in Geneva, seeking damages. The company cannot yet assess the potential liability and intends to defend itself vigorously[38](index=38&type=chunk)
Kamada .(KMDA) - 2022 Q1 - Earnings Call Transcript
2022-05-17 15:06
Kamada Ltd. (NASDAQ:KMDA) Q1 2022 Earnings Conference Call May 17, 2022 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors Amir London - Chief Executive Officer Chaime Orlev - Chief Financial Officer Conference Call Participants Operator Greetings. Welcome to the Kamada Ltd. First Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Bob Yedid of LifeSci Advisors. You may begin. Bob Yedid Tha ...
Kamada .(KMDA) - 2021 Q4 - Earnings Call Transcript
2022-03-15 13:48
Financial Data and Key Metrics Changes - Total revenues in 2021 were $103.6 million, a decrease from $133.2 million in 2020, primarily due to the transition of GLASSIA manufacturing to Takeda, resulting in a $38.7 million year-over-year decrease [32] - EBITDA in 2021 totaled $5.4 million, down from $25.1 million in 2020, attributed to changes in product sales mix [34] - Cash, cash equivalents, and short-term investments decreased to $18.6 million as of December 31, 2021, from $109.3 million at the end of 2020 [36] - Revenue guidance for 2022 is between $125 million to $135 million, representing a 20% to 30% growth compared to 2021, with expected EBITDA margins of 12% to 15% [10][38] Business Line Data and Key Metrics Changes - Revenues generated from the newly acquired portfolio amounted to $5.4 million for the period from November 22, 2021, through the end of the year [33] - The largest product in the acquired portfolio is Cytogam, which is expected to significantly contribute to revenue and gross margins once manufacturing is transferred to Kamada's facility [16][40] Market Data and Key Metrics Changes - KedRAB continues to gain market share in the $150 million U.S. market, with anticipated significant sales growth in the coming years [21][22] - The company plans to leverage its international distribution network to grow product revenues in new territories, primarily in Asia, Latin America, and the Middle East [13] Company Strategy and Development Direction - Kamada aims to become a fully integrated specialty plasma company with six FDA-approved products and strong commercial capabilities in the U.S. market [9] - The acquisition of a plasma collection facility in Texas supports the strategic goal of enhancing plasma collection capacity [18] - The company is focused on expanding its distribution business, including the planned distribution of a portfolio of 11 biosimilar products expected to launch between 2022 and 2028 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's growth trajectory, expecting continued double-digit growth in the coming years [11][30] - The strategic acquisition of FDA-approved products is seen as a critical step for enhancing revenue and profitability [12] Other Important Information - The company incurred approximately $1.2 million in transaction-related expenses and $600,000 in excess severance costs due to downsizing after the transition of GLASSIA manufacturing [35] - A new Vice President for U.S. Commercial Operations has been appointed to lead commercial activities for the expanded product portfolio [14] Q&A Session Summary Question: How long will it take to transition the additional products to the Israeli manufacturing facility, and how will that enhance gross margins over time? - Management indicated that the tech transfer for Cytogam is already underway, with FDA approval expected by early 2023. The transfer for the other three products is expected to be completed within the next three to five years, which will significantly enhance gross margins [40][41]
Kamada .(KMDA) - 2021 Q4 - Annual Report
2022-03-15 11:06
[PART I](index=10&type=section&id=PART%20I) [Key Information](index=10&type=section&id=Item%203.%20Key%20Information) This section outlines principal risks from the Saol acquisition, GLASSIA sales cessation, and U.S. market reliance [Risk Factors](index=10&type=section&id=D.%20Risk%20Factors) The company faces risks from the Saol acquisition, GLASSIA revenue loss, and U.S. market concentration - The ability to realize anticipated benefits from the acquisition of four FDA-approved plasma-derived products from Saol is **critical for future growth and profitability**[30](index=30&type=chunk)[32](index=32&type=chunk) - Revenues from the newly acquired products and GLASSIA royalties **may not fully offset the significant decrease in revenue** from ceasing GLASSIA manufacturing for Takeda[30](index=30&type=chunk)[39](index=39&type=chunk)[41](index=41&type=chunk) - The company is **heavily reliant on its Proprietary Products segment (73% of 2021 revenue)** and the U.S. market (48% of 2021 revenue)[42](index=42&type=chunk)[44](index=44&type=chunk) - Following the transition of GLASSIA manufacturing to Takeda, the company may have **excess manufacturing capacity**, potentially reducing efficiency and profitability[45](index=45&type=chunk)[46](index=46&type=chunk) - The success of expanding U.S. plasma collection operations is **critical for future growth and plasma self-sufficiency**[30](index=30&type=chunk)[48](index=48&type=chunk) - The company relies on third-party distributors for ex-U.S. markets, which accounted for **approximately 17% of total revenues in 2021**[67](index=67&type=chunk) - The company depends on Contract Manufacturing Organizations (CMOs), such as Emergent BioSolutions, for the manufacturing of **HEPGAM B, VARIZIG, and WINRHO SDF**[31](index=31&type=chunk)[96](index=96&type=chunk) - The COVID-19 pandemic has caused and may continue to cause **operational disruptions**, including delays in raw material receipt, product shipments, and clinical trials[55](index=55&type=chunk)[56](index=56&type=chunk)[147](index=147&type=chunk) [Information on the Company](index=84&type=section&id=Item%204.%20Information%20on%20the%20Company) The company operates as a biopharmaceutical firm with a focus on plasma-derived products and strategic acquisitions [Business Overview](index=85&type=section&id=Business%20Overview) The company operates through Proprietary Products and Distribution segments, projecting significant 2022 revenue growth - Kamada operates through two segments: **Proprietary Products** (plasma-derived therapeutics) and **Distribution** (third-party pharmaceuticals in Israel)[307](index=307&type=chunk) - The company's strategy focuses on driving **profitable growth** through its commercial portfolio, manufacturing expertise, and development pipeline[306](index=306&type=chunk) Fiscal Year 2022 Financial Guidance | Metric | Guidance Range/Value | | :--- | :--- | | Total Revenues | $125 million to $135 million | | Revenue Growth vs. FY2021 | 20% to 30% | | EBITDA as % of Total Revenues | 12% to 15% | [Recent Acquisitions](index=86&type=section&id=Recent%20Acquisitions) The company executed two strategic acquisitions in 2021, buying a product portfolio from Saol and a plasma center - In November 2021, Kamada acquired a portfolio of **four FDA-approved plasma-derived hyperimmune commercial products** from Saol[316](index=316&type=chunk) Saol IgG Portfolio Acquisition Details | Financial Term | Amount | | :--- | :--- | | Upfront Payment | $95 million | | Contingent Consideration | Up to $50 million | | Acquired Inventory Value | $14.4 million | | 2021 Global Revenue of Portfolio | ~$41.9 million | | Kamada's Revenue from Portfolio (post-acquisition in 2021) | ~$5.4 million | - In March 2021, Kamada acquired an FDA-licensed plasma collection center from B&PR in Beaumont, Texas for **approximately $1.61 million**, marking its entry into the U.S. plasma collection market[323](index=323&type=chunk) [Our Commercial Product Portfolio](index=89&type=section&id=Our%20Commercial%20Product%20Portfolio) The commercial portfolio is split between the Proprietary Products segment and the Distribution segment in Israel Revenue Contribution by Segment (as % of Total Revenues) | Segment | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Proprietary Products | 73% | 76% | 77% | | Distribution | 27% | 24% | 23% | - Key proprietary products include **GLASSIA** (AATD treatment), **KEDRAB** (rabies prophylaxis), and the newly acquired portfolio for indications such as CMV prophylaxis and ITP[309](index=309&type=chunk)[339](index=339&type=chunk)[344](index=344&type=chunk) - The Distribution segment is expanding its portfolio with **eleven biosimilar products**, expected to launch between 2022 and 2028 with a peak annual revenue potential of over $40 million[313](index=313&type=chunk)[373](index=373&type=chunk)[375](index=375&type=chunk) [Our Development Product Pipeline](index=100&type=section&id=Our%20Development%20Product%20Pipeline) The development pipeline is led by an inhaled AAT for AATD, currently in a pivotal Phase 3 clinical trial - The lead pipeline product is an **Inhaled AAT for AATD**, currently in the pivotal Phase 3 InnovAATe clinical trial[314](index=314&type=chunk)[383](index=383&type=chunk) - The InnovAATe trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of Inhaled AAT in **up to 250 patients with AATD** over two years[398](index=398&type=chunk) - The company developed an Anti-SARS-CoV-2 IgG product, generating **$3.9 million in revenue in 2021**, with the program's continuation under evaluation[406](index=406&type=chunk)[407](index=407&type=chunk) - Kamada is also advancing the development of a **recombinant human Alpha 1 Antitrypsin (rhAAT)** product with a CDMO[408](index=408&type=chunk) [Strategic Partnerships](index=104&type=section&id=Strategic%20Partnerships) The company maintains key partnerships with Takeda for GLASSIA royalties and Kedrion for KEDRAB distribution - The partnership with Takeda for GLASSIA has shifted to a royalty agreement, with Kamada receiving **12% of net sales through August 2025 and 6% thereafter until 2040**[413](index=413&type=chunk)[418](index=418&type=chunk) - Kamada has an exclusive distribution and supply agreement with Kedrion for the marketing of **KEDRAB** in the United States, with the term running until March 2024[422](index=422&type=chunk)[423](index=423&type=chunk)[425](index=425&type=chunk) - The company has a license agreement with PARI for the exclusive worldwide use of its **eFlow® nebulizer** for the inhaled AAT product candidate[427](index=427&type=chunk) [Manufacturing and Supply](index=108&type=section&id=Manufacturing%20and%20Supply) The company operates an FDA-approved plant in Israel and relies on CMOs and third-party plasma suppliers - The company operates a single, **FDA-approved manufacturing facility** in Beit Kama, Israel, for its proprietary plasma-derived products[186](index=186&type=chunk)[434](index=434&type=chunk) - Technology transfer for **CYTOGAM manufacturing** to the Beit Kama facility is underway, with commercial production expected in early 2023[434](index=434&type=chunk) - HEPAGAM B, VARIZIG, and WINRHO SDF are manufactured by Emergent under a contract, with plans to **eventually transfer manufacturing to Kamada's facility**[438](index=438&type=chunk) - The main raw materials are **hyper-immune plasma and fraction IV**, sourced from multiple third-party suppliers including Takeda and Kedrion[439](index=439&type=chunk)[441](index=441&type=chunk)[444](index=444&type=chunk) [Competition](index=111&type=section&id=Competition) The company faces competition from large multinational firms in both its Proprietary and Distribution segments - Major competitors in the plasma-derived therapeutics market include **CSL Behring, Grifols, Takeda, and Kedrion**[69](index=69&type=chunk)[459](index=459&type=chunk) - For KEDRAB, **Grifols holds an estimated 70%-80% market share** in the United States[72](index=72&type=chunk)[463](index=463&type=chunk) - For GLASSIA, competitors include Grifols and CSL, with potential disruption from **new therapies like gene therapy and oral inhibitors**[79](index=79&type=chunk)[468](index=468&type=chunk)[469](index=469&type=chunk) - In the Israeli Distribution segment, Kamada competes with local distributors for large pharmaceutical manufacturers such as **Novartis, AstraZeneca, and Sanofi**[139](index=139&type=chunk)[471](index=471&type=chunk) [Government Regulation](index=114&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by global authorities, including the FDA and EMA - Products are regulated as biologics in the U.S. and require an approved **Biologics License Application (BLA)** from the FDA before marketing[473](index=473&type=chunk) - The manufacturing facility in Israel is subject to periodic inspections to ensure compliance with **current Good Manufacturing Practice (cGMP)** standards[435](index=435&type=chunk)[492](index=492&type=chunk) - Kamada has received **Orphan Drug Designation** for Inhaled AAT, providing market exclusivity upon approval (7 years in U.S., 10 years in E.U.)[484](index=484&type=chunk)[485](index=485&type=chunk)[486](index=486&type=chunk) - The company is subject to complex U.S. healthcare laws, including the **Patient Protection and Affordable Care Act (ACA)**, which impacts pricing and rebates[510](index=510&type=chunk)[517](index=517&type=chunk) [Operating and Financial Review and Prospects](index=128&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section analyzes financial performance, highlighting a revenue decrease due to the GLASSIA transition [Results of Operations](index=138&type=section&id=Results%20of%20Operations) Total revenues decreased 22.2% in 2021, driven by the planned cessation of GLASSIA manufacturing for Takeda Consolidated Statement of Operations Data (in thousands USD) | | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$103,642** | **$133,246** | **$127,187** | | Gross Profit | $30,328 | $47,552 | $49,737 | | Operating Income (Loss) | ($696) | $19,237 | $22,784 | | Net Income (Loss) | ($2,230) | $17,140 | $22,251 | Segment Results Comparison: 2021 vs. 2020 (in thousands USD) | | 2021 | 2020 | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | | | | | Proprietary Products | $75,521 | $100,916 | (25.2)% | | Distribution | $28,121 | $32,330 | (13.0)% | | **Total Revenues** | **$103,642** | **$133,246** | **(22.2)%** | | **Gross Profit** | | | | | Proprietary Products | $27,327 | $43,166 | (36.7)% | | Distribution | $3,001 | $4,386 | (31.6)% | | **Total Gross Profit** | **$30,328** | **$47,552** | **(36.2)%** | - The decrease in 2021 revenue was primarily due to the **transition of GLASSIA manufacturing to Takeda**, resulting in a $38.7 million year-over-year decrease in GLASSIA sales[585](index=585&type=chunk) - Gross margin for the Proprietary Products segment **decreased from 42.8% in 2020 to 36.2% in 2021**, attributed to changes in product mix and reduced plant utilization[587](index=587&type=chunk)[588](index=588&type=chunk)[589](index=589&type=chunk) - Research and Development expenses **decreased by 16.2% to $11.4 million in 2021**, mainly due to reduced clinical trial costs[592](index=592&type=chunk) - Selling and Marketing expenses **increased by 39% to $6.3 million in 2021**, primarily due to costs associated with the newly acquired Saol portfolio[595](index=595&type=chunk) - General and Administrative expenses **increased by 24.6% to $12.6 million in 2021**, largely due to $1.2 million in transaction costs for the Saol acquisition[597](index=597&type=chunk) [Liquidity and Capital Resources](index=149&type=section&id=Liquidity%20and%20Capital%20Resources) Cash position decreased significantly due to the $95 million Saol acquisition, partially funded by new debt Cash and Short-Term Investments (in millions USD) | Date | Amount | | :--- | :--- | | Dec 31, 2021 | $18.6 | | Dec 31, 2020 | $109.3 | | Dec 31, 2019 | $73.9 | - In November 2021, the company secured a **$40 million debt facility** from Bank Hapoalim B.M. to partially fund the Saol acquisition[628](index=628&type=chunk) Cash Flow Summary (in millions USD) | Cash Flow From | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Operating Activities | ($8.8) | $19.1 | $27.6 | | Investing Activities | ($61.1) | ($13.1) | ($0.6) | | Financing Activities | $18.6 | $23.3 | ($1.5) | - Net cash used in investing activities in 2021 was **$61.1 million**, primarily comprising the $96.4 million for acquisitions, offset by dispositions of investments[635](index=635&type=chunk) - The company believes its **current cash and cash equivalents are sufficient** to satisfy liquidity requirements for the next 12 months[627](index=627&type=chunk) [Critical Accounting Policies and Estimates](index=152&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section details key accounting policies requiring management judgment, such as revenue recognition and M&A - **Revenue Recognition**: Revenue is recognized when control transfers; variable consideration is included only when a significant reversal is highly improbable[643](index=643&type=chunk)[645](index=645&type=chunk) - **Business Combinations**: Acquisitions are accounted for using the acquisition method, requiring significant estimates for intangible assets and contingent consideration[647](index=647&type=chunk)[651](index=651&type=chunk) - **Inventory Valuation**: Inventory is measured at the lower of cost or net realizable value, with cost allocation based on a standard manufacturing capacity[659](index=659&type=chunk)[660](index=660&type=chunk) - **Impairment of Non-financial Assets and Goodwill**: The company reviews assets for impairment when indicators are present and tests goodwill annually[664](index=664&type=chunk)[667](index=667&type=chunk) [Directors, Senior Management and Employees](index=162&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the company's leadership, board structure, compensation, and employee information - The Board of Directors consists of nine members, with **seven of the nine directors considered independent** under Nasdaq listing requirements[698](index=698&type=chunk)[721](index=721&type=chunk) Aggregate Compensation of Directors and Officers (2021) | Category | Amount (USD) | | :--- | :--- | | Total Compensation | ~$3.05 million | | Pension/Severance Accrual | ~$0.27 million | Compensation of Top 5 Executives (2021, in thousands USD) | Name | Position | Salary | Bonus | Value of Options | Other | Total | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Amir London | CEO | $412 | $89 | $141 | $21 | $663 | | Chaime Orlev | CFO | $264 | $48 | $11 | $19 | $342 | | Eran Nir | COO | $256 | $35 | $10 | $31 | $332 | | Orit Pinchuk | VP, Regulatory | $227 | $24 | $10 | $23 | $284 | | Yifat Philip | VP, General Counsel | $201 | $24 | $33 | $22 | $280 | - As of December 31, 2021, the company employed **355 people in Israel and 9 in the U.S.**, a reduction from 408 in 2020 due to the GLASSIA manufacturing transition[789](index=789&type=chunk) - The company has a collective bargaining agreement with employees at its Beit Kama facility, and **negotiations for a new agreement were ongoing** as of March 2022[790](index=790&type=chunk) [Major Shareholders and Related Party Transactions](index=190&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section details major shareholders, including FIMI Funds, and transactions with affiliated parties Major Shareholders (as of March 15, 2022) | Shareholder | Beneficial Ownership (%) | | :--- | :--- | | FIMI Funds | 21.10% | | The Phoenix Holdings Ltd. | 8.11% | | Leon Recanati | 8.06% | - The company has a distribution agreement with Tuteur S.A.C.I.F.I.A., a company where **director Jonathan Hahn is President**, for distribution in Latin America[817](index=817&type=chunk)[820](index=820&type=chunk) - In January 2020, the company completed a **$25 million private placement with the FIMI Funds**, increasing FIMI's ownership to approximately 21%[824](index=824&type=chunk) - A shareholders' agreement exists between the Recanati Group and the Damar Group regarding **voting for the election of each other's director nominees**[822](index=822&type=chunk) [Financial Information](index=195&type=section&id=Item%208.%20Financial%20Information) This section refers to the consolidated financial statements provided in full under Item 18 of this report - The consolidated financial statements are set forth under **Item 18** of this annual report[826](index=826&type=chunk) [Additional Information](index=195&type=section&id=Item%2010.%20Additional%20Information) This section covers corporate governance, material contracts, exchange controls, and tax considerations - The company is incorporated under the laws of Israel and its purpose is to **engage in any lawful business**[829](index=829&type=chunk) - There are currently **no Israeli currency control restrictions** on remittances of dividends or proceeds from the sale of shares to non-residents of Israel[837](index=837&type=chunk) - The company has benefited from Israel's Law for the Encouragement of Capital Investments, providing for **reduced corporate tax rates**, with some benefits expiring at the end of 2023[847](index=847&type=chunk)[849](index=849&type=chunk)[851](index=851&type=chunk) - For U.S. Holders, there is a risk the company could be classified as a **Passive Foreign Investment Company (PFIC)**, which would result in adverse U.S. tax consequences[893](index=893&type=chunk)[900](index=900&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=210&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, primarily interest rate risk and foreign currency fluctuations - The company is exposed to **interest rate risk** from its financial assets and debt[910](index=910&type=chunk) - The company faces significant **foreign currency risk**, particularly from fluctuations of the NIS and Euro against the U.S. dollar[912](index=912&type=chunk)[913](index=913&type=chunk) - To mitigate currency risk, the company uses hedging strategies, including forward currency contracts, with open transactions of **approximately $19.7 million** as of year-end 2021[914](index=914&type=chunk) - A **10% increase in the value of the NIS against the U.S. dollar** would have decreased the company's financial assets by $0.06 million as of December 31, 2021[916](index=916&type=chunk) [Controls and Procedures](index=214&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2021[925](index=925&type=chunk) - Management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2021, based on the COSO 2013 framework[926](index=926&type=chunk) - The independent registered public accounting firm issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting[927](index=927&type=chunk) [Financial Statements](index=218&type=section&id=Item%2018.%20Financial%20Statements) This section contains the audited consolidated financial statements prepared in accordance with IFRS - The report includes the **audited consolidated financial statements** for the fiscal years ended December 31, 2021, 2020, and 2019[944](index=944&type=chunk) - The financial statements have been prepared in accordance with **International Financial Reporting Standards (IFRS)** as issued by the IASB[956](index=956&type=chunk) - The independent auditor's report identifies **inventory valuation and Saol acquisition accounting** as Critical Audit Matters[960](index=960&type=chunk)
Kamada .(KMDA) - 2022 Q1 - Quarterly Report
2022-03-15 11:02
Exhibit 99.1 Kamada Reports Fiscal Year and Fourth Quarter 2021 Financial Results; Provides Revenue and Profitability Guidance with Significant Growth Expected in 2022 REHOVOT, Israel – March 15, 2022 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today announced financial results for the 12 and three months ended December 31, 2021. "2021 was a transformational year for Kamada in our path toward becomi ...
Kamada .(KMDA) - 2021 Q3 - Earnings Call Transcript
2021-11-22 17:07
Financial Data and Key Metrics Changes - In Q3 2021, total revenues were $23 million, down from $35.3 million in Q3 2020. For the first nine months of 2021, total revenues were $72.2 million, a decrease from $101.7 million in the same period of 2020, primarily due to reduced GLASSIA sales [9][10] - Gross profit for Q3 2021 was $5.7 million compared to $14.8 million in Q3 2020. Total gross profit for the first nine months of 2021 was $23.7 million, down from $37.4 million in the same period of 2020 [11][12] - The net loss for Q3 2021 was approximately $800,000 or $0.02 per share, compared to net income of $6.8 million or $0.15 per share in Q3 2020. For the first nine months of 2021, net income was $2.8 million or $0.06 per share, down from $15.5 million or $0.35 per share in the same period of 2020 [13][14] Business Line Data and Key Metrics Changes - The acquisition of four FDA-approved plasma-derived commercial products from Saol Therapeutics is expected to generate global revenue of $40 million to $45 million for the full year 2021, with approximately 75% of sales in the U.S. and Canada [16][25] - The four products include CYTOGAM, VARIZIG, WINRHO, and HEPAGAM B, with CYTOGAM accounting for approximately 50% of the portfolio revenue [18][20] Market Data and Key Metrics Changes - The acquired products are expected to have gross margins between 50% to 55% for the full year 2021, which is a significant improvement compared to the current product mix [16][39] - Kamada's commercial footprint now extends to over 30 countries, with the addition of eight new international markets primarily in the Middle East [25] Company Strategy and Development Direction - The strategic acquisition positions Kamada as a global leader in the plasma-derived hyperimmune market, with plans to integrate the new portfolio to drive revenue and profitability growth in 2022 [17][30] - The company aims to establish a fully-integrated specialty plasma company with strong commercial capabilities in the U.S. market, leveraging existing distribution networks to grow revenue in new geographic markets [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the overall business, highlighting multiple profitable lines that can drive significant long-term growth opportunities [32][46] - The integration of the newly acquired portfolio is expected to result in significant growth in revenues and profitability in 2022, following a temporary decline in 2021 due to the transition of GLASSIA manufacturing to Takeda [17][48] Other Important Information - Kamada will pay Saol $95 million upfront and up to an additional $50 million in sales milestones from 2022 to 2034, along with acquiring existing inventory valued at approximately $15 million [28] - A $40 million credit facility has been secured from Bank Hapoalim to partially fund acquisition costs, consisting of a $20 million five-year term loan and a $20 million short-term revolving credit facility [29] Q&A Session Summary Question: Revenue breakdown across the four products and growth profile - CYTOGAM accounts for approximately 50% of the portfolio revenue, with WINRHO and HEPAGAM generating between $8 million to $12 million, and VARIZIG around $3 million to $6 million [36] Question: Production support for the four products - The products come with an established supply chain, and Kamada plans to grow its own hyperimmune plasma collection capabilities to support the portfolio [38] Question: Margin profile and operating expenses - Outside the U.S., existing distribution channels will be used without adding pressure on costs, while a focused U.S. sales team will be established to promote the products [40] Question: GLASSIA Takeda royalties range - The range of $10 million to $20 million is based on a 12% royalty starting in 2022, which will drop to 6% in 2025 [41][42] Question: InnovAATe trial updates - A successful DSMB meeting was held, and additional study sites are planned to open in early 2022 [43]
Kamada .(KMDA) - 2021 Q3 - Quarterly Report
2021-11-22 12:02
Exhibit 99.2 KAMADA LTD. CONSOLIDATED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2021 (Unaudited) TABLE OF CONTENTS | | Page | | --- | --- | | Consolidated Statements of Financial Position | 2 | | Consolidated Statements of Profit or Loss and Other Comprehensive Income | 3 | | Consolidated Statements of Changes in Equity | 4-7 | | Consolidated Statements of Cash Flows | 8-9 | | Notes to the Interim Consolidated Financial Statements | 10-20 | - - - - - - - - - - - KAMADA LTD. CONSOLIDATED STATEMENTS OF FINANCI ...
Kamada .(KMDA) - 2021 Q2 - Earnings Call Transcript
2021-08-11 18:50
Financial Data and Key Metrics Changes - In Q2 2021, total revenues were $24.2 million, down from $33.1 million in Q2 2020, reflecting a decrease due to the transition of Glassia sales to Takeda [15] - For the first half of 2021, total revenues were $49.1 million compared to $66.4 million in the same period of 2020, primarily due to reduced sales of Glassia [15] - Gross profit for Q2 2021 was $9.1 million, down from $11.1 million in Q2 2020, while gross margin improved to 37% from 34% year-over-year [16] - Net income for Q2 2021 was approximately $900,000 or $0.02 per share, compared to $3.5 million or $0.10 per share in Q2 2020 [18] Business Line Data and Key Metrics Changes - Sales of Glassia to Takeda amounted to approximately $17 million in the first half of 2021, with an expected total of $25 million for the full year [15][16] - The company anticipates a shift in product sales mix in the second half of 2021, with higher sales in distribution products that have lower gross margins [17] Market Data and Key Metrics Changes - The FDA approved a label update for KEDRAB, which is expected to increase market share and revenues in the US, where the HRIG market is estimated at $150 million annually [8] - The company completed the supply of a plasma-derived immunoglobulin product to the Israeli Ministry of Health, generating approximately $3.4 million in revenues [10] Company Strategy and Development Direction - The company aims to evolve into a vertically integrated specialty plasma-derived company, focusing on product development and acquisition [12] - Plans to expand plasma collection capacity in the US are underway, leveraging an FDA license to open additional centers [10][12] - The company is engaged in discussions for strategic business development opportunities that could significantly impact its operations [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's strength and the potential for long-term growth opportunities [13] - The ongoing COVID-19 pandemic continues to impact sales, but management anticipates meaningful growth in KEDRAB sales in the coming years [8] Other Important Information - The company had a cash position of approximately $105 million as of June 30, 2021, down from $109 million at the end of 2020, primarily due to working capital timing differences [18][19] Q&A Session Summary Question: Timing for Bonsity and Hyperimmune globulin contract manufacturing - Management confirmed that the biosimilar product is on track for launch in early 2022, with tech transfer proceeding as planned [22] Question: Updates on InnovAATe trial and plasma centers - The InnovAATe study is ongoing, with plans to expand and open additional sites, while the company is focused on high premium plasma collection [25][26]
Kamada .(KMDA) - 2021 Q1 - Earnings Call Transcript
2021-05-12 16:41
Kamada Ltd. (NASDAQ:KMDA) Q1 2021 Earnings Conference Call May 12, 2021 8:30 AM ET Company Participants Bob Yedid – LifeSci Advisors Amir London – Chief Executive Officer Chaime Orlev – Chief Financial Officer Conference Call Participants Anthony Petrone – Jefferies Keay Nakae – Chardan Capital Markets Operator Greetings. Welcome to the Kamada Ltd. First Quarter 2021 Earnings Conference Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your h ...