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Conference call begins today at 8:30 a.m. Eastern time
NESS ZIONA, Israel (February 2, 2016) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, reports financial results for the three and 12 months ended December 31, 2015.
Financial highlights of the 2015 fourth quarter and full year 2015 included:
Other highlights of the 2015 fourth quarter and recent weeks included:
Expected milestones over the coming months include:
“We made considerable progress throughout 2015 and are particularly pleased with the number of important commercial and clinical milestones achieved during the fourth quarter,” stated Amir London, Chief Executive Officer of Kamada. “The latest extension to our agreement with Baxalta increases their minimum purchase commitment through 2018 by $50 million and underscores Glassia's growing market acceptance in the U.S. as well as its importance to Baxalta's AATD franchise. Importantly, this third extension also extends our manufacturing supply through the end of 2018 and gives us confidence in our ability to achieve growth in the Proprietary Products segment and to attain our 2017 revenue goal of $100 million based on this commitment, as well as the increasing number of patients treated with Glassia, which is not yet reflected in our 2015 revenues but continues to grow by double-digit percentage year over year. We are also encouraged with the improved gross margin in our Proprietary Products segment, which increased to 40% this quarter.
“Our clinical development activities are broadly distributed across a number of disease states and include programs in various stages of development. We are excited to be just months away from two significant regulatory submissions, including the MAA for our inhaled AAT to treat AATD in Europe and a BLA for our Rabies IgG as a prophylactic treatment for rabies exposure in the U.S. Each indication offers significant market opportunity and we look forward to working with our commercial partners for these products to realize their potential.
“We are encouraged by the positive interim data recently reported from the ongoing U.S. Phase 1/2 clinical trial with our IV AAT to treat steroid-resistant GvHD. We look forward to the final results of this study and to developing plans for further development in this indication. In addition, we will be initiating a Phase 1/2 clinical trial with our IV AAT to prevent lung transplantation rejection. Both programs, which add up to over a billion dollar market potential, are being conducted in collaboration with Baxalta.
“The progress we made in 2015 positions us well to continue executing our growth strategy, while advancing our clinical development programs across several important orphan indications of unmet medical need. We look forward to achieving a number of notable, value-creating milestones in the coming months,” concluded Mr. London.
Fourth Quarter Financial Results
Total revenues for the fourth quarter of 2015 were $25.9 million compared with $24.9 million for the fourth quarter of 2014. Revenues from the Proprietary Product segment were $17.7 million compared with $19.1 million in the year-ago fourth quarter, primarily due to ordering patterns from Baxalta during the year. Revenues from the Distributed Product segment were $8.1 million for the fourth quarter of 2015 compared with $5.8 million in the same quarter of 2014.
Gross profit for the fourth quarter of 2015 was $8.3 million compared with $7.5 million for the fourth quarter of 2014. Gross margin increased to 32% from 30% in the fourth quarter of 2014. Gross margin in the Proprietary Products segment was 40% in the fourth quarter, a two-year record high, and compared with gross margin of 36% in the 2014 fourth quarter.
Research and development expenses in the fourth quarter of 2015 were $4.4 million, an increase from $3.4 million in the fourth quarter of 2014, as the Company continued to support various clinical trials and to allocate facility capacity for research and development in preparation for regulatory submissions in 2016.
Selling, general and administrative expenses in the fourth quarter of 2015 of $3.0 million increased from $2.4 million in the fourth quarter of 2014.
For the fourth quarter of 2015, the Company reported operating income of $0.8 million compared with operating income of $1.6 million for the fourth quarter of 2014. The Company recorded net income for the fourth quarter of 2015 of $1.0 million or $0.03 per diluted share, compared with net income of $1.2 million or $0.03 per diluted share for the same period in 2014. Adjusted net income for the fourth quarter of 2015 was $1.4 million compared with adjusted net income of $1.8 million for the same period in 2014.
Adjusted EBITDA for the fourth quarter of 2015 was an income of $2.0 million compared with income of $2.8 million for the fourth quarter of 2014.
Full Year Financial Results
Total revenues for 2015 were $70.1 million compared with $71.1 million for 2014. Revenues in the Proprietary Product segment were $43.2 million compared with $44.4 million for 2014, and revenues in the Distributed Product segment were $27.0 million compared with $26.7 million in 2014. These results met the lower range of the Company's projection for the year 2015, which was $70 million to $73 million.
Gross profit for 2015 was $16.0 million compared with $15.0 million for 2014, and 2015 gross margin increased to 23% from 21% in 2014.
Operating loss for 2015 of $11.4 million compared with an operating loss of $11.5 million for 2014. Net loss for 2015 was $11.3 million or $0.31 per share, compared with a net loss of $13.2 million or $0.37 per share for 2014. The adjusted net loss for 2015 was $9.4 million compared with an adjusted net loss of $9.5 million for 2014.
Adjusted EBITDA for 2015 was a loss of $6.3 million compared with a loss of $4.9 million for 2014.
Balance Sheet Highlights
As of December 31, 2015, Kamada had cash, cash equivalents and short-term investments of $28.3 million, compared with $51.9 million as of December 31, 2014. During 2015, the Company used $13.9 million in cash to fund operations, $2.8 million for capital expenditures and $7.8 million for repayment of convertible debt.
Kamada management will host an investment community conference call today beginning at 8:30 a.m. Eastern time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 888-803-5993 (from within the U.S.), 706-634-5454 (from outside the U.S.) or 1-809-315-362 (toll-free from Israel) and entering the conference identification number: 38830870. The call will also be webcast live on the internet on the Company's website at www.kamada.com.
A replay of the call will be accessible two hours after its completion through February 8, 2016 by dialing 855-859-2056 (from within the U.S.) or 404-537-3406 (from outside the U.S.) and entering the conference identification number: 38830870. 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 robust 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 and only 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 Baxalta. In addition to Glassia, Kamada has a product line of nine other injectable pharmaceutical products 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 five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that completed pivotal Phase 2/3 clinical trials in Europe and is in Phase 2 clinical trials in the U.S. and its intravenous AAT to treat type-1 diabetes, GvHD and to prevent lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing 10 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 27A of the U.S. Securities Act of 1933, as amended, 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, such as statements regarding assumptions and results related to financial results forecast, commercial results, timing and results of clinical trials and EMA and U.S. FDA authorizations. 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 clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays. 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.
Gil Efron Anne Marie Fields
-Financial Tables to Follow-