UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the Month of September 2024
Commission File Number 001-35948
Kamada Ltd.
(Translation of registrant’s name into English)
2 Holzman Street
Science Park, P.O. Box 4081
Rehovot 7670402
Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒
Form 40-F ☐
This Form 6-K is being incorporated by reference
into the Registrant’s Form S-8 Registration Statements, File Nos. 333-192720,
333-207933, 333-215983,
333-222891, 333-233267
and 333-265866.
The following exhibit is attached:
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 23, 2024 |
KAMADA LTD. |
| |
|
| |
By: |
/s/ Nir Livneh |
| |
|
Nir Livneh
Vice President General Counsel and
Corporate Secretary |
EXHIBIT INDEX
3
Exhibit 99.1
Kamada Announces Expansion of Plasma Collection
Operations in Texas with the Opening of New Site in Houston
| ● | New Plasma Collection Center in Houston Now Open, with
Planned Annual Collection Capacity of Approximately 50,000 Liters and an Estimated Annual Revenue Contribution of $8 Million to $10 Million
at its Full Capacity |
| ● | Center Will Collect Normal Source Plasma and Specialty
Plasma, such as Anti-Rabies and Anti-D, and is Anticipated to be One of the Largest Sites for Specialty Plasma Collection in the U.S. |
| ● | The New Center Supports Kamada’s Strategy and Development
as a Leading Global Vertically-Integrated Specialty Plasma-Derived Company |
| ● | Kamada Expects to Open its Third Plasma Collection Center
in San Antonio, TX, During the First Half of 2025 |
REHOVOT, Israel, and HOBOKEN, NJ – September
23, 2024 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated
for rare and serious conditions and a leader in the specialty plasma-derived field, today announced the expansion of its plasma collection
operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada’s
wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately
50,000 liters annually.
“We are extremely pleased to announce the
opening of our new state-of-the-art plasma collection center in Houston,” said Amir London, Chief Executive Officer of Kamada. “The
opening of this center is an important milestone in Kamada’s development and vertical integration, expanding the collection capacity of
specialty plasma for our internal use beyond our existing site in Beaumont, TX. The new center in Houston is expected to be one of the
largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. We are
especially grateful for the skilled and experienced team of plasma collection experts we have hired to lead the development and operations
of our new center.”
Kamada intends to submit to the FDA a prior approval
supplement to Kamada Plasma’s existing Biologics License Application (BLA) for the approval of the Houston site, as well as a plasma master
file (PMF) to the European Medicines Agency (EMA), during the first half of 2025. The FDA and EMA’s regulatory process for obtaining
approval for plasma collection centers includes onsite inspection. During the review process, the company is authorized to collect plasma
donations at the center. Kamada currently anticipates approval decisions within 9-12 months of submissions.
In addition to the new Houston center, the company
has begun construction of its third plasma collection site in San Antonio, TX, which is expected to open during the first half of 2025.
Each collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its
full capacity.
About Kamada
Kamada Ltd. (the “Company”) is a global
biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty
plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline
targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant
commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s
commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®,
VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom
(ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors
in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin
America, Europe, the Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for
use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company
added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the
Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection
center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D),
KARAB and KEDRAB and recently opened a new plasma collection center in Houston, Texas in which it plans to collect normal source plasma
and specialty plasma, such as Anti-Rabies and Anti-D. In addition to the Company’s commercial operation, it invests in research
and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of
AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal
Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially
owning approximately 38% of the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements
within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements
regarding: 1) an estimated total annual collection capacity of approximately 50,000 liters and an estimated annual revenue contribution
of $8 to $10 million of the new plasma collection center in Houston from sales of normal source plasma at its full capacity; 2) the center
will collect normal source plasma to be sold to third parties and specialty plasma such as Anti-Rabies and Anti-D, and is expected to
be one of the largest sites for specialty plasma collection in the U.S; 3) Kamada expects to open its third plasma collection center in
San Antonio during the first half of 2025; 4) the new center is planned to support over 50 donor beds; 5) the company plans to submit
with the FDA a prior approval supplement to Kamada Plasma’s Biologics License Application (BLA) for the approval of the Houston site and
submit with the European Medicines Agency (EMA) a plasma master file (PMF) for its approval, during the first half of 2025 and currently
anticipates such approvals decision within 9-12 months of submission; and 6) each collection center is expected to contribute annual revenues
of $8 to $10 million from sales of normal source plasma at its full capacity. Forward-looking statements are based on Kamada’s current
knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.
Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result
of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts
in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry
and political conditions in Israel, the U.S. and globally, continuation of inbound and outbound international delivery routes, continued
demand for Kamada’s products, financial conditions of the Company’s customer, suppliers and services providers, Kamada’s
ability to integrate the new product portfolio into its current product portfolio, Kamada’s ability to grow the revenues of its
new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the acquisition
of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived
hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results
of clinical studies, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes,
regulatory delays, including the BLA and PMF approvals related to the plasma collection centers, prevailing market conditions and the
impact of general economic, industry or political conditions in the U.S., Israel or otherwise, and other risks detailed in Kamada’s
filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report
on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s
website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes
no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required
by law.
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com
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