Kamada Reports Financial Results for the Fourth Quarter and Full-Year 2016
Total revenues for 2016 were $77.5 million, an 11% increase over 2015
Full year 2016 Proprietary Product revenues up over 30%
Reaffirms revenue guidance of $100 million for 2017
Conference Call Today at 8:30am Eastern Time
NESS ZIONA, Israel, Feb. 06, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (KMDA) (KMDA.TA), a plasma-derived protein therapeutics company focused on orphan indications, announced today financial results for the three and twelve months ended December 31, 2016.
“We are very pleased with our accomplishments in 2016,” said Amir London, Chief Executive Officer. “We met our revenue guidance for full year 2016, with over 30% growth in our Proprietary Products revenues compared with the previous year, and look forward to a higher rate of revenue growth in this segment in 2017. Moreover, the extension of our supply agreement with Shire for GLASSIA® through 2020 underscores Shire’s solid outlook for higher long-term demand for GLASSIA® in the U.S. This minimum revenue commitment by Shire - $237 million over four years - further strengthens our confidence in achieving our guidance of $100 million in total revenues in 2017 and represents further growth in the following years.”
“Additionally, we achieved a number of key development milestones during 2016, and look forward to multiple additional regulatory and clinical development-related value-creating milestones in 2017. We were pleased to announce last August that our U.S. Phase 2 study of inhaled Alpha-1 Antitrypsin (AAT) for the treatment of AAT Deficiency met its primary endpoint of a significant increase in endothelial lining fluid inhibitory capacity. We recently submitted this data to the European Medicines Agency (EMA) in support of our filed Inhaled AAT Marketing Authorization Application (MAA) as part of our response to the day 120 comments, and will also use it in our discussions with the FDA in order to identify a regulatory path for inhaled AAT in the U.S.,” added Mr. London.
Financial Highlights for the Twelve Months Ended December 31, 2016:
Total revenues for 2016 were $77.5 million, an 11% increase from $69.9 million in 2015.
Revenues from the Proprietary Products segment in 2016 were $56.0 million, a 30.3% increase from $43.0 million in 2015.
Gross profit for 2016 was $21.7 million, a 37.0% increase from the $15.8 million in 2015.
Gross margin increased to 27.9 percent from 22.6 percent in 2015.
Net loss was $6.7 million in 2016, or $0.18 per share, compared to a net loss of $11.3 million, or $0.31 per share in the same period of 2015.
Adjusted net loss was $5.6 million compared to adjusted net loss of $9.4 million in the same period of 2015.
Financial Highlights for the Three Months Ended December 31, 2016:
Total revenues were $24.3 million for the fourth quarter of 2016, a 5.5% decrease from $25.6 million in the fourth quarter of 2015.
Revenues from the Proprietary Products segment were $17.7 million, essentially flat as compared to the same period of 2015.
Gross profit was $5.0 million, a 38.3% decrease from the $8.0 million in the same period of 2015.
Gross margin decreased to 20.5 percent from 31.4 percent in the same period of 2015.
Net loss was $1.8 million, or $0.05 per share, compared to net income of $1.0 million, or $0.03 per share, in the same period of 2015.
Adjusted net loss was $1.8 million compared to adjusted net income of $1.4 million in the same period of 2015.
Recent Corporate Highlights:
Extended strategic partnership with Shire plc for supply and distribution of GLASSIA®. Minimum revenue for Kamada for the four-year period from 2017 to 2020 will reach approximately $237 million and may be expanded to $288 million during that period. This extension represents the fourth time the companies have extended the contract for manufacturing supply of GLASSIA® since the start of the strategic relationship in 2010.
Announced plans for a Phase 2/3 clinical trial of Alpha-1 Antitrypsin IV (G1-AAT IV) for the treatment of Graft-Versus-Host Disease (GvHD) in collaboration with Shire plc. This U.S. clinical trial will be a two-part, multi-center, prospective study to evaluate the safety and efficacy of G1-AAT IV as an add-on biopharmacotherapy to conventional steroid treatment in up to 168 patients with acute GvHD (aGvHD) with lower gastrointestinal involvement. G1-AAT IV previously received orphan drug designation from the FDA and EMA for the treatment of GvHD, and an Investigational New Drug Application was submitted to the FDA earlier this year.
Received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA around the Company’s development program in Europe for G1-AAT IV for the treatment of aGvHD with lower gastrointestinal involvement. The response from the CHMP included important guidance related to the design of Kamada’s planned Phase 2/3 European study and the regulatory pathway for approval based on conducting such a study.
Signed a collaboration agreement with Yissum Research Development Company of the Hebrew University of Jerusalem for the development of an efficient and robust eukaryotic expression system for recombinant human Alpha 1 Antitrypsin (rhAAT). The goal of this development work is to maximize protein yields and functionality.
“We are pleased with 2016’s strong financial performance, including meeting our revenue guidance, reducing our reported net losses and generating a positive cash flow in the fourth quarter and in the full year of 2016,” said Gil Efron, Deputy CEO and Chief Financial Officer. “Growth of 30% in revenues from our Proprietary Products drove our strong financial performance in 2016, resulting in a net loss of $6.7 million, a 40% year-over-year decrease.”
“As a consequence of our expected growth in total revenues in 2017 to $100 million, a projected increase of nearly 30% year-over-year, we project that Kamada will be profitable in 2017, even while continuing our R&D investment in support of our product pipeline,” added Mr. Efron.
Full Year 2016 versus 2015
Total revenues for 2016 were $77.5 million, up 11% as compared to $69.9 million for 2015. Revenues from the Proprietary Products segment for 2016 were $56.0 million, up 30% as compared to $43.0 million in 2015. Distributed Products revenue was $21.5 million for 2016, a decrease of 20% compared to $27.0 million in 2015.
Gross profit for 2016 grew 40% to $21.7 million, compared to $15.8 million during 2015. Gross margin increased to 27.9% for 2016 from 22.6% in 2015.
R&D expenses in 2016 were $16.2 million, a slight decrease compared to $16.5 million in 2015. Selling, general and administrative expenses of 2016 were $10.9 million, an increase of 2% compared to $10.7 million in 2015. For 2016, the Company reported an operating loss of $5.5 million, compared with an operating loss of $11.4 million in 2015. The net loss for 2016 was $6.7 million, or ($0.18) per diluted share, compared with a net loss of $11.3 million, or ($0.31) per diluted share, in the same period of 2015.
Negative Adjusted EBITDA for 2016 was $0.9 million, compared with negative Adjusted EBITDA of $6.3 million for 2015. Adjusted net loss was $5.6 million in 2016, compared with an adjusted net loss of $9.4 million in 2015.
Fourth Quarter 2016 Financial Results Compared to Fourth Quarter 2015 Financial Results
