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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 has acquired a portfolio of four FDA-approved plasma-derived hyperimmune products from Saol Therapeutics for $95 million upfront and up to $50 million in sales milestones through 2034. The global revenue from the products is estimated between $40 million to $45 million, with 75% of sales from the U.S. and 20% from Canada. This acquisition positions Kamada to become a global leader in plasma-derived therapies, enhancing its commercial capabilities in the U.S. market while gaining access to eight additional international markets, mainly in the MENA region.
Kamada Ltd. (NASDAQ: KMDA) reported Q3 2021 revenues of $23.0 million, down from $35.3 million in Q3 2020. The company acquired a portfolio of four FDA-approved plasma-derived products from Saol Therapeutics, expected to generate annual revenues of $40 million to $45 million. The transition of GLASSIA® manufacturing to Takeda is complete, moving to a royalty phase in 2022. The company aims to expand its plasma collection capabilities in the U.S. while advancing the Phase 3 InnovAATe trial for Inhaled AAT. As of September 30, 2021, cash and equivalents stood at $99.8 million.
Kamada Ltd. (NASDAQ: KMDA), a plasma-derived biopharmaceutical company, will announce its financial results for the three and nine months ending September 30, 2021, on November 22, 2021. An investment community conference call is scheduled for the same day at 8:30 AM ET, allowing stakeholders to discuss results. Kamada is recognized for its products, GLASSIA and KEDRAB, supported by significant partnerships. The company aims to enhance its growth through commercial products and a robust development pipeline, including treatments for AAT deficiency and COVID-19.
Kamada Ltd. (NASDAQ: KMDA) reported second-quarter 2021 revenues of $24.2 million, down from $33.1 million in Q2 2020. Gross profit decreased to $9.1 million, yielding a gross margin of 37%. The company completed a workforce downsizing, anticipated to reduce annual labor costs by 10%. Net income fell to $0.9 million ($0.02 per share) from $3.5 million ($0.10 per share). Adjusted EBITDA was $2.4 million. Kamada is advancing its Phase 3 InnovAATe trial for inhaled AAT and plans to expand plasma collection centers.
Kamada Ltd. (NASDAQ: KMDA) will release its financial results for Q2 2021 on August 11, before U.S. markets open. A conference call to discuss these results will follow at 8:30 AM ET, available via telephone or a live webcast. The company's leading products include GLASSIA® and KEDRRAB®, with GLASSIA being the first FDA-approved liquid AAT product. Kamada is also advancing clinical trials for inhaled AAT and a hyperimmune IgG product for COVID-19. FIMI Opportunity Fund is the lead shareholder, owning approximately 21% of the company.
Kamada's KEDRAB® has received a significant label update from the FDA, making it the first and only human rabies immune globulin (HRIG) clinically studied in children. This new indication allows for KEDRAB's use in individuals of all ages, crucially addressing the fact that up to 40% of rabies exposures involve children under 15. The label update stems from a successful post-marketing pediatric trial, demonstrating both safety and effectiveness. Kamada anticipates this approval could increase its market share in the estimated $150 million annual U.S. HRIG market.
Kamada Ltd. (NASDAQ: KMDA) reported Q1 2021 revenues of $24.9 million, reflecting a 25% decline from Q1 2020. The net income was $2.7 million or $0.06 per share, down from $5.2 million or $0.12 per share last year. Adjusted EBITDA was $3.7 million, compared to $6.3 million in Q1 2020. Kamada plans to transfer the GLASSIA manufacturing license to Takeda by year-end, receiving $2 million. The company will also downsizes its workforce to cut costs by 10% annually. The Phase 3 InnovAATe trial for inhaled AAT continues, and Kamada remains focused on expanding plasma collection capabilities.
Kamada Ltd. (NASDAQ: KMDA) will announce its financial results for Q1 2021 on May 12, 2021, before the U.S. markets open. Management will hold a conference call at 8:30 AM ET the same day to discuss the results and address inquiries. Kamada's portfolio includes plasma-derived products such as GLASSIA and KEDRAB, with continued production agreements in place with Takeda Pharmaceuticals. The company is also advancing clinical trials for treatments related to COVID-19 and AAT deficiency. Kamada is focused on leveraging its manufacturing capabilities for profitable growth.
Kamada Ltd. (NASDAQ: KMDA) has announced a significant transition in its GLASSIA manufacturing process. Kamada will transfer the U.S. Biologics License Application (BLA) to Takeda by the end of 2021, receiving a $2 million payment for the transfer. Additionally, a final $5 million sales-based milestone payment from Takeda was accelerated. Despite this shift, Kamada will continue marketing GLASSIA outside Takeda's territories while investing in the development of an inhaled AAT product, currently in a Phase III clinical trial. Revenue forecasts include approximately $25 million from GLASSIA sales in 2021.
Kamada Ltd. (NASDAQ: KMDA) announced positive results from its Phase 1/2 clinical trial of its anti-SARS-CoV-2 plasma-derived hyperimmune globulin treatment for COVID-19. Out of 12 patients, 11 recovered, with 7 discharged by Day 5. The treatment showed no infusion-related reactions, and IgG levels increased significantly, enhancing virus neutralization. The company continues supplying its IgG product to the Israeli Ministry of Health for COVID-19 patients, anticipating $3.4 million in revenue from the initial order to treat 500 patients. Manufacturing is ramping up for potential international demand.
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