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NESS ZIONA, Israel (November 10, 2015) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces financial results for the three and nine months ended September 30, 2015.
Financial highlights of the 2015 third quarter included:
Other highlights of the 2015 third quarter and recent weeks included:
Upcoming value creating milestones over the coming months include:
“Throughout the third quarter we made meaningful progress with our commercial business as well as our clinical programs,” stated Amir London, Chief Executive Officer of Kamada. “We executed a third extension to our agreement with Baxalta, which provides an additional $50 million in minimum revenue commitments and extends our manufacturing supply through the end of 2018. This extension validates the growing market acceptance of Glassia in the U.S. and gives us better visibility into revenues for the coming years. Importantly, it strengthens our confidence in our ability to meet our 2017 revenue goal of $100 million, which includes approximately 75% growth in the Proprietary Products Segment.
“Our 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. As a result, we have a rich clinical development program including studies underway to support the expansion of intravenous Glassia to treat type 1 diabetes and graft-versus-host-disease (GVHD). Also, in collaboration with Baxalta we plan to initiate a Phase 2 clinical study of our AAT for the prevention of lung transplantation rejection in the first quarter of 2016. We continue to make progress with preparations to submit a MAA to the EMA for our inhaled AAT to treat AATD, and plan to submit the MAA in the first quarter of 2016. In addition, we expect to report results from the Phase 3 clinical trial of our Rabies IgG, performed in collaboration with Kedrion, our U.S. partner, by year-end and we plan to submit a BLA with the FDA in the first half of 2016.
“Our robust product pipeline is broadly distributed across several important disease states with significant unmet medical need, which diversifies our risk and offers multiple opportunities for partnerships and additional sources of revenue,” he added.
“We are delighted to welcome Dr. Berelowitz to our Board of Directors. His considerable industry experience and insight into successful commercialization and clinical strategies are already proving to be great assets to Kamada as we advance and expand our clinical development programs for our immunomodulatory plasma-derived protein therapeutics. His extensive knowledge of the diabetes landscape will be particularly valuable as we advance clinical plans of our AAT to treat recent onset type 1 diabetes.
“It has been an exciting time at Kamada as we continue to build on our core commercial business to grow revenue, while advancing a number of important clinical studies with the goal of bringing safe and effective therapies to patients in need,” concluded Mr. London.
Third Quarter Financial Results
Total revenues for the third quarter of 2015 of $16.1 million compared with $17.2 million for the third quarter of 2014. Revenue from the Proprietary Products Segment was $9.6 million compared with $9.1 million in the year-ago quarter. Revenue from the Distributed Product Segment was $6.5 million for the third quarter of 2015 compared with $8.0 million in the same quarter of 2014.
Gross profit for the third quarter of 2015 was $3.7 million compared with gross profit of $4.4 million for the third quarter of 2014. Gross margin decreased to 23% from 26% in the third quarter of 2014, due to a decrease in gross profit in the Proprietary Products segment as a result of product mix.
Research and development expenses in the third quarter of 2015 were $5.0 million, an increase from $4.2 million in the third quarter of 2014 as the company continued to support various clinical studies.
Selling, general and administrative expenses in the third quarter of 2015 of $2.7 million were unchanged from $2.7 million in the third quarter of 2014.
For the third quarter of 2015, the Company reported an operating loss of $4.0 million compared with an operating loss of $2.5 million for the third quarter of 2014. The Company recorded a net loss for the third quarter of 2015 of $4.6 million or $0.13 per share, compared with a net loss of $2.9 million or $0.09 per share for the same period in 2014. The adjusted net loss for the third quarter of 2015 was $4.1 million compared with an adjusted net loss of $1.9 million for the same period in 2014.
Adjusted EBITDA for the third quarter of 2015 was a loss of $2.7 million compared with a loss of $0.8 million for the third quarter of 2014.
Nine Month Financial Results
Total revenue for the first nine months of 2015 of $44.2 million compared with $46.1 million for the first nine months of 2014. Revenue in the Proprietary Products Segment was $25.4 million compared with $25.3 million for the same period in 2014, and revenue in the Distribution Segment was $18.8 million compared with $20.8 million in the prior-year period.
Gross profit year-to-date 2015 was $7.7 million compared with $7.6 million in the same period of 2014, and gross margin increased to 17% from 16% in the comparable prior-year period.
Operating loss for the first nine months of 2015 of $12.2 million compared with operating loss of $13.1 million for the first nine months of 2014. Net loss for the first nine months of 2015 was $12.3 million or $0.34 per share, compared with a net loss of $14.4 million or $0.41 per share for the same period in 2014.
Adjusted EBITDA for the first nine months of 2015 was a loss of $8.3 million compared with a loss of $8.0 million for the same period last year.
Balance Sheet Highlights
As of September 30, 2015, Kamada had cash, cash equivalents and short-term investments of $42.3 million, compared with $44.3 million as of June 30, 2015. During the third quarter of 2015, the Company used $0.9 million in cash to fund operations and $0.6 million for capital expenditures.
2015 Revenue Guidance
For the year ending December 31, 2015, Kamada expects total revenue to be between $70 million and $73 million, with revenue from its Distributed Product Segment projected to be between $26 million and $28 million and revenue from its Proprietary Products Segment projected to be between $45 million and $47 million. The Company notes that revenue projections for 2015 take into account an expected negative foreign exchange impact of approximately $2.0 million in relation to product sales in Israel and Russia, and presume that U.S. revenue from the agreement with Baxalta remains on track.
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 809-315-362 (toll-free from Israel) and entering the conference identification number: 75038084. 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 November 16, 2015 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: 75038084. 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 proteins. 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, Eastern Europe 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 prevention of 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.