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REHOVOT, Israel – May 14, 2019 — Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three months ended March 31, 2019.
“We are extremely pleased with our solid start to 2019,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues in the first quarter of 2019 were $26.8 million, representing a 54% increase as compared to the first quarter of 2018. These results were primarily driven by increased sales of GLASSIA® and KedRAB®, our anti-rabies IgG product. From a profitability standpoint, our gross profits, as well as operating and net income, improved substantially year-over-year in the first quarter of 2019. We generated $4.9 million in net income in the first quarter of 2019, an increase of over 292% as compared to net income of $1.3 million in the 2018 first quarter.”
“Based on our strong performance in the first quarter, and our positive outlook for the remainder of the year, we are reaffirming our full-year 2019 total revenue guidance of $125 million to $130 million, which, if achieved, would represent another strong year of double-digit percentage growth for Kamada over full-year 2018 total revenues,” continued Mr. London. “This guidance reflects continued growth of both of our core products, GLASSIA and KedRAB, in 2019. As a reminder, our GLASSIA supply agreement with Takeda, which extends through the end of 2020, will be followed by an expected flow of future royalty payments for 20 years, until 2040.”
“In addition to growing our commercial business, we are also advancing our clinical development pipeline. We announced recently the receipt of a letter from the U.S. Food and Drug Administration (FDA) stating that we have satisfactorily addressed the FDA’s prior concerns and questions regarding Kamada’s Inhaled AAT program. The FDA’s response followed the positive scientific advice that we received in July 2018 from the Committee for Medicinal Products for Human Use of the European Medicines Agency. We intend to conduct a unified global pivotal Phase 3 clinical trial in the U.S. under an Investigational New Drug application and in Europe under a Clinical Trial Authorization in order to submit marketing applications for regulatory approval in both regions. We expect to initiate the Phase 3 study during the second half of 2019, subject to the successful completion of the FDA required Human Factor Study, which was recently initiated.”
Financial Highlights for the Three Months Ended March 31, 2019
Balance Sheet Highlights
As of March 31, 2019, the Company had cash, cash equivalents, and short-term investments of $55.8 million, as compared to $50.6 million at December 31, 2018.
As of January 1, 2019, the Company adopted IFRS 16 (Leases), which resulted in an increase of property, plant and equipment, as well as bank loans and leases, in the amounts of $4.1 million and $4.7 million, respectively. Additional related information can be found in the Company’s audited financial statements for the year ended December 31, 2018, included in our recently filed Annual Report on Form 20-F.
Recent Corporate Highlights
Kamada management will host an investment community conference call on Tuesday, May 14 at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1 809 406 247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13689683. The call will also be webcast live on the Internet on the Company’s website at www.kamada.com.
The call will also be archived for 90 days on the Company’s website at www.kamada.com.
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other counties through local distributors. Kamada’s second leading product is KamRAB, a rabies immune globulin (Human) for Post-Exposure Prophylaxis against rabies infection. KamRAB is FDA approved and is being marketed in the U.S. under the brand name KEDRAB and through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, Kamada has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency, and in addition, its intravenous AAT is in development for other indications, such as GvHD, prevention of lung transplant rejection and type-1 diabetes. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.
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 Kamada’s continued revenue growth of our marketed proprietary products, including GLASSIA and KedRAB in the U.S., re-affirmation of the 2019 revenue guidance, our expectation for 20 years of royalties from Takeda post 2020, continued prospects in our development pipeline, including: the timing of the start of the unified global pivotal Phase 3 clinical trial in the second half of 2019 for the Inhaled AAT program and successful results from such a clinical trial, the successful completion of the Human Factor Study in the second quarter of 2019, which is a necessary component to start the clinical trial for the Inhaled AAT program, and our plans to submit marketing applications for regulatory approval in both the U.S. and Europe. 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, unexpected results of ongoing clinical studies, delays with the studies, additional competition in the markets that Kamada competes, including AAT, regulatory delays, prevailing market conditions, corporate events associated with our partners, including Takeda, and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. 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.
Chief Financial Officer
LifeSci Advisors, LLC