St Saviour's and St Olave's Church of England School

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

Retrieved on: 
Wednesday, May 24, 2023

“We are off to an excellent start to 2023, both financially and operationally,” said Amir London, Kamada’s Chief Executive Officer.

Key Points: 
  • “We are off to an excellent start to 2023, both financially and operationally,” said Amir London, Kamada’s Chief Executive Officer.
  • “As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million, which would represent profitability growth of over 30% as compared to 2022.
  • During the first quarter of 2023, Kamada conducted a planned workforce downsizing at its Israeli plant, optimizing staff level to its capacity needs.
  • Kamada continues to expect to generate fiscal year 2023 total revenues in the range of $138 million to $146 million.

Kamada Announces U.S. FDA Approval of its Application to Manufacture CYTOGAM® at the Company’s Facility in Israel

Retrieved on: 
Wednesday, May 3, 2023

The FDA approval represents the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring.

Key Points: 
  • The FDA approval represents the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring.
  • A similar technology transfer application was submitted to the Canadian health authorities in January 2023 and is currently under review.
  • “The U.S. FDA approval of this application to manufacture CYTOGAM, which was granted within our expected timeline, following a successful on-site inspection by the FDA, represents a significant accomplishment for Kamada.
  • We intend to initiate commercial manufacturing of CYTOGAM at our Israeli facility shortly, which will positively impact the facility’s utilization and efficiency.

Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer

Retrieved on: 
Thursday, March 16, 2023

The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.

Key Points: 
  • The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.
  • These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.
  • BRAF V600 mutations are present in 15-20% of pediatric LGGs and are associated with poor survival outcomes and less favorable response to chemotherapy4.
  • BRAF mutations have been identified as drivers of cancer growth across a wide range of solid tumors, and often have limited treatment options4,5.

Kamada Issues 2023 CEO Letter to Shareholders

Retrieved on: 
Wednesday, March 15, 2023

The recently completed 2022 year was a transformational period for Kamada as we embarked on a new and exciting chapter in the Company’s evolution.

Key Points: 
  • The recently completed 2022 year was a transformational period for Kamada as we embarked on a new and exciting chapter in the Company’s evolution.
  • Looking ahead, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further increased as compared to the past year.
  • I am pleased to report that we anticipate continued growth in the portfolio's revenues in 2023 and beyond.
  • Importantly, looking past 2023, based on our multiple catalysts, we continue to project annual double-digit growth in revenues and profits in the foreseeable years ahead.

Kamada Reports Strong Fiscal Year and Fourth Quarter 2022 Financial Results, and Provides 2023 Guidance Representing Significant Profitability Growth

Retrieved on: 
Wednesday, March 15, 2023

“Importantly, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced.

Key Points: 
  • “Importantly, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced.
  • As such, we are introducing full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million.
  • Total revenues during the fourth quarter of 2022 included strong sales from the portfolio of four acquired FDA-approved IgG products.
  • Adjusted EBITDA, as detailed in the tables below, was $7.2 million in the fourth quarter of 2022, as compared to ($1.3) million in the fourth quarter of 2021.