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Kamada Ltd. (KMDA) is a leading biopharmaceutical company that specializes in plasma-derived protein therapeutics, targeting orphan indications. Utilizing its proprietary platform technology, Kamada excels in the extraction and purification of proteins from human plasma, producing highly-purified, liquid forms of alpha-1 antitrypsin (AAT) and other plasma-derived proteins. AAT is recognized for its immunomodulatory, anti-inflammatory, tissue-protective, and antimicrobial properties.
One of Kamada's flagship products is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration (FDA). Kamada markets Glassia in the U.S. through a strategic partnership with Baxter International. In addition to Glassia, Kamada offers a diverse product portfolio, including nine other pharmaceutical products distributed globally.
Kamada's robust late-stage product pipeline underscores its commitment to innovation in the specialty therapeutics market. The company operates through two primary segments: the Proprietary Products segment and the Distribution segment, with the majority of revenue derived from the Proprietary Products segment. Kamada's product categories encompass lung diseases, vaccines, hemophilia, immunoglobulins, critical care, and diagnostics.
Recently, Kamada announced a significant development in its strategic partnership with Kedrion Biopharma. The companies have executed a binding memorandum of understanding for an 8-year extension of the KEDRAB® US distribution agreement, starting January 2024. This agreement includes potential expansion of Kedrion's distribution of KEDRAB® beyond the U.S. and collaboration on expanding Kedrion products' distribution in Israel.
KEDRAB® is a Human Rabies Immune Globulin (HRIG) used for passive, transient post-exposure prophylaxis (PEP) of rabies infection, approved by the FDA in August 2017. The agreement signifies a significant milestone for Kamada, maximizing the future growth and value potential of this important product. Kamada continues to prioritize patient care and remains a pivotal player in the plasma-derived therapies sector.
Kamada Ltd. (Nasdaq: KMDA) announced on July 15, 2022, the signing of a new collective agreement with the Employees’ Union of its Beit Kama production facility and the Histadrut, effective until 2029. This agreement resulted in the resolution of a previously disclosed labor strike, allowing employees to return to work. Despite this, the company anticipates a negative impact on its second quarter financial results due to a one-time loss linked to the work stoppage, although it did not affect the availability of commercial products.
Kamada Ltd. (NASDAQ: KMDA) has secured an $11.4 million agreement to supply VARIZIG® to an undisclosed international organization focused on Latin America. The product supply is anticipated from the fourth quarter of 2022 to the first half of 2023. This agreement highlights Kamada’s expanding international presence and the commercial potential of their FDA-approved plasma-derived therapies. VARIZIG is crucial for post-exposure prophylaxis of chickenpox in high-risk patients, and is the only FDA-approved IgG product for this use.
Kamada Ltd. (NASDAQ: KMDA) has promoted Shavit Beladev to Vice President of Plasma Operations and Boris Gorelik to Vice President of Business Development. Ms. Beladev, with over 20 years at Kamada, will manage the U.S. plasma collection expansion, while Mr. Gorelik will focus on business development and strategic partnerships. CEO Amir London emphasized these promotions align with the company's strategy to enhance its U.S. presence in specialty plasma therapeutics. Kamada is known for its diverse portfolio of FDA-approved plasma-derived products and ongoing clinical trials.
STADA is launching Hukyndra®, a high-concentration, citrate-free biosimilar to adalimumab, in select European markets including France, Germany, Finland, and Sweden. This launch follows approval from the European Commission and represents the first product from STADA's partnership with Alvotech. Hukyndra® is designed to enhance patient comfort with reduced injection-site pain. The biosimilar is approved for treating various inflammatory conditions, supporting patient access to vital therapies in Europe.
Kamada Ltd. (NASDAQ: KMDA) announced a virtual meeting on June 7, 2022, to discuss growth catalysts. Presenters include CEO Amir London and CFO Chaime Orlev. The company projects 2022 revenue of $125M-$135M, a 20%-30% increase from 2021, with EBITDA margins of 12-15%. Key growth initiatives include expanding U.S. sales, entering the plasma collection market in Texas, and increasing royalties from GLASSIA®. Kamada also aims to distribute 11 biosimilars in Israel with anticipated peak sales of over $40M. The company is enrolling for a Phase 3 study of inhaled AAT for AAT deficiency.
Kamada Ltd. reported Q1 2022 revenues of $28.1 million, a 13% year-over-year increase. The company reiterated its full-year revenue guidance of $125 million to $135 million, projecting a 20% to 30% growth compared to 2021. Gross margins improved to 40%, up from 36% in Q1 2021. Kamada generated $5.5 million in operating cash flows, raising total available cash to $22 million. The company noted a net loss of $1.8 million in the quarter, mainly impacted by increased operating expenses due to R&D and sales efforts.
Kamada Ltd. (NASDAQ: KMDA) provided an update on its pivotal Phase 3 InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin (AAT) therapy, targeting Alpha-1 Antitrypsin Deficiency (AATD). The trial is expanding to new sites in Belgium, Finland, Sweden, the UK, Ireland, and the Netherlands, with patient enrollment underway. The Independent Data Safety Monitoring Board (DSMB) has recommended continuing the trial without modifications, reporting no serious adverse events. The trial aims to enroll up to 250 patients, assessing lung function and other parameters over two years.
Kamada Ltd. (NASDAQ: KMDA) will announce its financial results for Q1 2022 on May 17, before U.S. markets open. The company, known for its specialty plasma-derived therapeutics, will conduct a conference call at 8:30 AM ET on the same day to discuss the results. Interested parties can join the call or access it via a live webcast. Kamada’s portfolio includes FDA-approved products like GLASSIA® and KEDRAB®, along with recently acquired plasma-derived hyperimmune products. The company aims to leverage its development pipeline and manufacturing capabilities to drive growth.
Kamada Ltd. (NASDAQ: KMDA) reported a transformational year in 2021, completing the transition of Glassia® manufacturing to Takeda and acquiring four FDA-approved immunoglobulins. The company anticipates 2022 revenues between $125M and $135M, reflecting 20%-30% growth, with EBITDA margins projected at 12%-15%. Kamada has entered the U.S. plasma collection market and plans to expand its product portfolio. Key products include Cytogam® and KedRAB®, with expected sales growth. The company is optimistic about its clinical pipeline, particularly its inhaled AAT treatment for AAT deficiency, currently in a pivotal Phase 3 trial.
Kamada Ltd. (NASDAQ: KMDA) reported total revenues of $103.6 million for fiscal year 2021 and $31.5 million for Q4 2021. For fiscal year 2022, revenues are projected to be between $125 million and $135 million, reflecting a 20% to 30% increase over 2021. EBITDA margins are expected to be 12% to 15%. The company is integrating newly acquired FDA-approved products and expanding U.S. plasma collection operations. A key highlight includes the initiation of GLASSIA royalty payments from Takeda in Q2 2022.