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Kamada .(KMDA) - 2021 Q3 - Quarterly Report
2021-11-22 12:02
Financial Performance - Total revenues for the three months ended September 30, 2021, were $72.173 million, a decrease of 29% compared to $101.704 million for the same period in 2020[4] - Gross profit for the three months ended September 30, 2021, was $23.733 million, down from $37.387 million in the same period of 2020, representing a decline of 36%[4] - Net income for the three months ended September 30, 2021, was $2.779 million, compared to $15.511 million for the same period in 2020, reflecting an 82% decrease[4] - Basic net earnings per share for the three months ended September 30, 2021, were $0.06, down from $0.35 in the same period of 2020[4] - The company reported a total comprehensive income of $2.457 million for the three months ended September 30, 2021, compared to $15.595 million for the same period in 2020, indicating a significant decline[4] - For the nine months ended September 30, 2021, Kamada Ltd. reported a net income of $2,779,000, a decrease from $15,511,000 in the same period of 2020[13] - The Company reported an income before taxes on income of $2,779 thousand for the nine months ended September 30, 2021, compared to $16,655 thousand for the same period in 2020, indicating a decline of approximately 83%[48] Assets and Liabilities - Total current assets as of September 30, 2021, were $178.943 million, slightly up from $174.511 million as of December 31, 2020[3] - Total assets increased to $216.527 million as of September 30, 2021, compared to $206.345 million as of December 31, 2020[3] - Total liabilities as of September 30, 2021, were $34.914 million, up from $29.616 million as of December 31, 2020[3] - Total shareholder's equity as of September 30, 2021, was $181.613 million, an increase from $176.729 million as of December 31, 2020[3] - As of September 30, 2021, total equity decreased to $181.613 million, with an accumulated deficit of $41.154 million[9] Cash Flow and Investments - Cash flows from operating activities for the nine months period were negative at $(3,850,000), compared to positive cash flow of $6,356,000 in the prior year[13] - The company generated $39,083,000 from short-term investments in the nine months period, contrasting with a net outflow of $(15,646,000) in the same period of 2020[14] - Cash flows from investing activities for the nine months period were $34,693,000, compared to $(19,011,000) in the same period of 2020[14] - The company reported a net cash used in financing activities of $(1,110,000) for the nine months period, a decrease from $23,767,000 in the prior year[14] Research and Development - Research and development expenses for the three months ended September 30, 2021, were $7.909 million, a decrease of 23% from $10.335 million in the same period of 2020[4] - Kamada's development pipeline includes an inhaled AAT for AAT deficiency and a plasma-derived hyperimmune immunoglobulin product for COVID-19 treatment[15] - The company has added nine biosimilar products to its distribution portfolio in Israel, expected to launch between 2022 and 2025, pending regulatory approvals[15] Acquisitions and Agreements - The acquisition of an FDA-licensed plasma collection center was completed for a total consideration of $1,654 thousand, with $1,404 thousand paid at closing and $250 thousand due on March 31, 2022[43] - The Company recognized a $5,000 thousand milestone as revenue during the first quarter of 2021 due to an amendment in the GLASSIA License Agreement with Takeda[42] - The company secured a $40 million credit facility from Bank Hapoalim to partially fund the acquisition costs, which includes a $20 million term loan and a $20 million short-term revolving credit facility[58] - The company has a royalty agreement with Takeda, which will pay 12% on net sales of GLASSIA until August 2025, with a minimum of $5 million annually from 2022 to 2040[16] Operational Challenges - The Company maintained higher inventory levels of raw materials to manage potential supply disruptions caused by the COVID-19 pandemic[37] - The Company incurred $561 thousand in costs associated with workforce downsizing due to the transition of GLASSIA manufacturing to Takeda, recorded as one-time expenses[42] - The financial impact of COVID-19 related disruptions on the Company's operations remains uncertain but is being assessed under various scenarios[40] Revenue Breakdown - In the U.S.A and North America, revenue for the nine months ended September 30, 2021, was $39.265 million, down from $66.339 million in the same period of 2020, representing a decline of 41%[53] - The company’s revenue from Israel for the nine months ended September 30, 2021, was $21.294 million, compared to $27.203 million in the same period of 2020, indicating a decrease of 22%[53] - Revenue from Europe for the nine months ended September 30, 2021, was $4.491 million, unchanged from the previous year[53] - The company’s revenue from Asia for the nine months ended September 30, 2021, was $1.753 million, a significant increase from $444 thousand in the same period of 2020[53]
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 ...
Kamada .(KMDA) - 2020 Q4 - Annual Report
2021-02-24 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Kamada .(KMDA) - 2020 Q4 - Earnings Call Transcript
2021-02-11 03:36
Financial Data and Key Metrics Changes - For the full year 2020, total revenues were $133.2 million, a 5% increase from $127.2 million in 2019, aligning with guidance of $132 million to $137 million [6][20] - Gross profit for Q4 2020 was $10.2 million with a gross margin of 33%, down from $12.1 million and 38% in Q4 2019 [21] - Net income for Q4 2020 was $1.6 million or $0.04 per share, compared to $5.4 million or $0.13 per share in Q4 2019 [23] Business Line Data and Key Metrics Changes - The distribution product segment margins were negatively impacted in 2020 due to a shift in product mix [21] - The company plans to expand its biosimilar product portfolio, expecting potential sales of $25 million to $35 million annually from nine biosimilar products [15][29] Market Data and Key Metrics Changes - The company is focused on increasing market share for KEDRAB in the U.S. and expanding GLASSIA sales in ex-U.S. markets [18] - The company anticipates generating royalties from GLASSIA projected to be in the range of $10 million to $20 million per year starting in 2022 [18] Company Strategy and Development Direction - Kamada aims to become a fully-integrated specialty plasma company by expanding its plasma-derived product business and enhancing manufacturing capabilities [8][10] - The company is developing its pipeline, focusing on the Phase III InnovAATe clinical trial for inhaled AAT and exploring new strategic business development opportunities [9][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's fundamentals despite challenges posed by the COVID-19 pandemic, highlighting a strong balance sheet and multiple growth catalysts [6][56] - The company expects reduced revenues and profitability in 2021 due to the transition of GLASSIA manufacturing and ongoing uncertainties from COVID-19 [24] Other Important Information - As of December 31, 2020, the company had cash balances of $109.3 million, up from $73.9 million a year earlier [24] - The company has initiated a supply of its COVID-19 IgG product to the Israeli Ministry of Health, expected to generate approximately $3.5 million in revenue [12] Q&A Session Summary Question: Can you describe the approval pathway for biosimilars? - Management indicated that approvals will primarily rely on EMA, with the Israeli Ministry of Health typically approving based on EMA or U.S. approval [28] Question: What is the annual collection capacity at Beaumont today? - Management did not disclose specific volumes but emphasized plans to maximize capacity and focus on hyperimmune plasma collection [34] Question: What should we anticipate for R&D spend in 2021? - Management expects R&D spend to remain similar to 2020, with recruitment timelines impacted by COVID-19 [43] Question: How should we think about product revenue in 2021? - Management did not provide specific guidance for 2021 due to COVID-19 uncertainties but indicated steady growth in the Israel Distribution business [50]
Kamada .(KMDA) - 2020 Q3 - Earnings Call Transcript
2020-11-11 19:51
Kamada Ltd. (NASDAQ:KMDA) Q3 2020 Results Earnings Conference Call November 11, 2020 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors Amir London - CEO Chaime Orlev - CFO Conference Call Participants Raj Denhoy - Jefferies Operator Greetings and welcome to the Kamada Limited Third Quarter 2020 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] As a reminder this conference is being re ...
Kamada .(KMDA) - 2020 Q2 - Earnings Call Transcript
2020-08-12 18:25
Kamada Ltd. (NASDAQ:KMDA) Q2 2020 Earnings Conference Call August 12, 2020 8:30 AM ET Company Participants Troy Williams – LifeSci Advisors Amir London – Chief Executive Officer Chaime Orlev – Chief Financial Officer Conference Call Participants Raj Denhoy – Jefferies Keay Nakae – Chardan Operator Welcome to the Kamada Limited Second Quarter 2020 Earnings Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will an oppor ...
Kamada .(KMDA) - 2020 Q1 - Earnings Call Transcript
2020-05-18 20:59
Kamada Ltd (NASDAQ:KMDA) Q1 2020 Results Conference Call May 18, 2020 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors Amir London - Chief Executive Officer Chaime Orlev - Chief Financial Officer Conference Call Participants Raj Denhoy - Jefferies Keay Nakae - Chardan Capital Markets Operator Greetings, welcome to the Kamada Limited First Quarter 2020 Earnings Conference Call. At this time, all participants will be in a listen-only mode. A brief question-and-answer session will follow the formal ...
Kamada .(KMDA) - 2019 Q4 - Annual Report
2020-02-26 14:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Kamada .(KMDA) - 2019 Q3 - Earnings Call Transcript
2019-11-14 03:01
Financial Data and Key Metrics Changes - Total revenues for Q3 2019 were $33.1 million, a significant increase from $15 million in Q3 2018 [30] - For the first nine months of 2019, total revenues reached $95.1 million, up 44% from $66.3 million in the same period of 2018 [34] - Gross profit for the nine months ended September 30, 2019, was $37.6 million, compared to $20.2 million in the prior year, with gross margins increasing to 40% from 31% [35][36] - Net income for the first nine months of 2019 was $16.9 million, compared to $4.6 million in the same period of 2018 [36] Business Line Data and Key Metrics Changes - Proprietary Products segment revenues in Q3 2019 were $24.9 million, up from $9.5 million in Q3 2018, driven by increased sales of GLASSIA and KEDRAB [31] - Distribution segment revenues were $8.2 million in Q3 2019, a 49% increase compared to Q3 2018 [32] Market Data and Key Metrics Changes - KEDRAB's US sales in its launch year (2018) were approximately $15.5 million, representing about a 10% market share [17] - The market for Inhaled AAT is currently valued at approximately $1 billion, with an annual growth rate of 6% to 8% [22] Company Strategy and Development Direction - The company extended its strategic supply agreement with Takeda for GLASSIA through 2021, projecting total revenue from sales of GLASSIA to Takeda between $155 million to $180 million from 2019 to 2021 [10][11] - Post-GLASSIA transition, the company aims to utilize its FDA-approved manufacturing plant for KEDRAB and other products in various markets [14] - The company is exploring opportunities to produce new plasma-derived products to maximize plant utilization [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong performance and positive outlook for the first quarter of the following year, reiterating full-year 2019 revenue guidance of $125 million to $130 million [10] - Management highlighted the importance of the Inhaled AAT program as a potential source of value creation for shareholders [60] Other Important Information - The company maintained a solid cash position of $66.8 million as of September 30, 2019, an increase from $50.6 million at the end of 2018 [38] - The company expects R&D spending to increase in the fourth quarter of 2019 and throughout 2020 due to the planned Phase III study for Inhaled AAT [37] Q&A Session Summary Question: Revenue contribution from GLASSIA and KEDRAB - Management does not provide detailed quarterly revenue breakdowns for GLASSIA and KEDRAB, only annual figures [43] Question: Any pull forward or stocking from Takeda? - Management indicated that there was nothing unusual regarding Takeda's inventory this year compared to previous years [44] Question: Transition preparations by Takeda - Takeda is working on completing its plants for FDA approval in 2021, and management will update the market on any changes [45] Question: Changes in transfer pricing or contribution margin on GLASSIA sales - There were no renegotiations of financial terms regarding GLASSIA sales to Takeda [46] Question: Business development plans post-GLASSIA transition - Management is confident in their ability to add new products and increase plant utilization after the transition [49] Question: Ease of manufacturing other plasma-based products post-transition - Management expressed strong confidence in their ability to manufacture additional products at their facility [52] Question: Growth prospects for GLASSIA outside the US - Management noted that gross profit for GLASSIA outside the US has been similar to that in the US, with a network of distributors in various regions [53] Question: Estimated total cost of the Phase III inhaled study - The total cost of the Phase III study is estimated to be between $30 million to $35 million [56]