Kamada Reports 2017 First Quarter Financial Results
Reaffirms revenue guidance of $100 million for 2017
Proprietary Products segment for 2017 projected at $76-$78 million, up at least 36% compared to 2016
Conference call today at 8:30 am Eastern Time
NESS ZIONA, Israel, May 16, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (KMDA) (KMDA.TA), a plasma-derived protein therapeutics company focused on orphan indications, today announced financial results for the first quarter ended March 31, 2017.
“Our first quarter revenues were impacted by a delay in completing a periodic validation of our filling line which resulted in a delay of shipping product batches,” said Amir London, Kamada’s Chief Executive Officer. “Subsequent to the end of the first quarter, the validation was successfully achieved and the delayed shipments will be made. As a result, all delayed revenues from our Proprietary Products segment, worth approximately $11.5M in revenue, will be shifted from the first quarter and recorded in the second quarter of this year. We remain highly confident in our ability to attain our previously stated guidance of reaching $100 million in total revenue in 2017, out of which $76 to $78 million will come from our Proprietary Products segment representing at least 36% growth year-over-year compared to 2016.”
“This significant growth in Proprietary Products sales is mainly the result of our increasing market share for Glassia® in the US, for the treatment of Alpha-1 Antitrypsin Deficiency, sold by Shire as part of the strategic agreement between our companies. Although the first quarter results are below our expectations, it is important to note that our total revenue for the quarter including the delayed shipments represent a revenue rate supporting our total annual guidance of $100 million,” added Mr. London.
“The remainder of 2017 includes multiple potentially value-enhancing milestones for Kamada, as follows:
We look forward to a regulatory decision from the European Medicines Agency (EMA) in the second half of the year regarding our inhaled Alpha-1 Antitrypsin (AAT) for the treatment of Alpha-1 Antitrypsin Deficiency
We expect to agree on a regulatory path forward with the FDA for the inhaled AAT in the US.
In addition, for our G1-AAT IV product in acute Graft-versus-Host Disease (GvHD), we are encouraged by the initiation of the Phase 2/3 trial in the US and we plan on submitting a Clinical Trial Authorization application to the EMA this year in order to conduct a Phase 2/3 study also in Europe.
In regards to Kamada’s human anti-rabies immunoglobulin therapy in the U.S., we are looking forward to the PDUFA date of August 29, 2017, for the FDA’s completion of their review of the previously accepted Biologics License Application.
It is important to note that all those products are already in an advanced regulatory review or in a late-stage clinical development and they represent a market potential of over $2 billion,” concluded Mr. London.
Financial Highlights for the Three Months Ended March 31, 2017:
Total revenues were $11.6 million, a 21% decrease from the $14.8 million reported in the first quarter of 2016.
Revenues from the Proprietary Products segment were $6.6 million, a 40% decrease from the $11.1 million reported in the first quarter of 2016.
Revenues from the Distributed Products segment were $5.0 million, a 36% increase from, the $3.7 million reported in the first quarter of 2016.
Gross profit was $2.3 million, a 52% decrease from the $4.8 million in the first quarter of 2016.
Gross margin decreased to 20% from 32% in the first quarter of 2016.
Net loss was $4.0 million, or loss of $0.11 per share, compared to a net loss of $2.3 million, or loss of $0.06 per share, in the first quarter of 2016.
Adjusted net loss was $3.7 million compared to adjusted net loss of $1.9 million in the first quarter of 2016.
Recent Corporate Highlights:
Hosted an R&D Day for investors and analysts focused on GvHD. The event featured presentations by key opinion leaders Dr. H. Joachim Deeg, of the Fred Hutchinson Cancer Research Center, and Dr. David M. Gelmont, formerly of Shire/Baxalta, who discussed the current treatment landscape for GvHD in bone marrow transplant patients, and the unmet medical need for patients who develop acute GvHD. In addition, Kamada’s management team provided an overview of the Company’s ongoing clinical development work with our intravenous AAT to treat acute GvHD.
Signed a collaboration with Massachusetts General Hospital to conduct a proof-of-concept study evaluating the potential benefit of Kamada’s AAT on liver preservation. The purpose of the study is to evaluate the effect of Kamada’s AAT on graft quality and viability, as well as assess the graft for markers of Ischemia-Reperfusion Injury caused to the liver.
Appointed Gwen A. Melincoff to the Company’s Board of Directors. Ms. Melincoff has over 25 years of leadership experience in the biotechnology and pharmaceutical industries spanning venture financing, business development, licensing, mergers and acquisitions, research operations, marketing, product management, project management, and public and private company boards.
First Quarter 2017 Financial Results Compared to First Quarter 2016 Financial Results
Total revenues for the first quarter of 2017 of $11.6 million decreased by 21% as compared to $14.8 million in the first quarter of 2016. Revenues from the Proprietary Products segment declined to $6.6 million for the first quarter of 2017, from $11.1 million in the first quarter of 2016. Proprietary Products revenues in the first quarter of 2017 were impacted by a delay in the Company’s ability to ship product batches as it awaited validation of its filling process. Kamada has since received that validation and expects that all delayed revenues from the first quarter will be recorded in the second quarter of 2017 as shipments are made. Distributed Products revenue was $5.0 million, an increase of 36%, as compared with $3.7 million in the first quarter of 2016.
Gross profit for the first quarter of 2017 was $2.3 million, a 52% decrease from the $4.8 million recorded in the first quarter of 2016. The decrease in gross profit is primarily due to the decrease in revenues of Proprietary Products and the mix of sales of Proprietary versus Distributed products.
R&D expenses in the first quarter of 2017 were $3.2 million, a 23% decrease from the $4.1 million recorded in the first quarter of 2016. Selling, general and administrative expenses were $2.9 million, up 7% from the $2.6 million in the same period in 2016. Operating loss in the first quarter of 2017 was $3.7 million, compared to the $2.0 million operating loss recorded in the same period of 2016. Net loss for the first quarter of 2017 was $4.0 million, or loss of $0.11 per diluted share, compared to a net loss of $2.3 million, or loss of $0.06 per diluted share, in the same period of 2016.
Negative Adjusted EBITDA for the first quarter of 2017 was $2.6 million, compared with Negative Adjusted EBITDA for the first quarter of 2016 of $0.8 million. Adjusted net loss for the first quarter of 2017 was $3.7 million, compared with an adjusted net loss of $1.9 million in the first quarter of 2016.
