Kamada Ltd. (TASE: KMDA) swung to profit on double-digit revenue growth in 2012.
Revenue rose 22% to $72.7 million in 2012 from $59.5 million in 2011, and the company posted a net profit of $260,000 compared with a net loss of $3.7 million the year before. The company swung from an operating loss of $2.5 million in 2011 to an operating profit of $4.2 million in 2012.
"We will publish our guidance for 2013 in April," CEO David Tsur told "Globes", and sounded optimistic about them. "I don’t know many companies with such revenue two years after obtaining US Food and Drug Administration (FDA) approval."
64% of Kamada's revenue came from proprietary products, including its lead product, Glassia, an intravenous treatment for Alpha-1 Antitrypsin Deficiency (AAT) protein deficiency in congenital emphysema, had $24 million sales in 2012. 36% of revenue came from the distribution of other companies' products, mostly in the Israeli market. Over time, this ratio is swinging in favor of proprietary product sales.
Kamada CFO Gil Efron said, "Although we will commence large clinical trials for diabetes in the coming years, we will complete the large trial for inhalable AAT, so we do not anticipate a major change in R&D expenditures.
One of Kamada's most important milestones in 2013 is obtaining the results of its Phase II/III clinical trial in Europe for inhalable AAT, due in December. The company already has a European distributor for the products, Chiesi Pharmaceuticals SpA and it hopes for a market launch in late 2014 or early 2015. "We're ready to produce inhalable AAT. It does not require any major changes compared with injectable AAT," said Tsur.
Kamada will commence a Phase II clinical trial of inhalable AAT in the US in mid-2013.
Kamada is pinning its biggest hopes on its treatment for Type 1 diabetes. Tsur said that the product can change the face of the company, because the diabetes market is huge compared with the niche markets of its current drugs. "We hope that the product can go directly to a Phase III clinical trial, because it is already registered for marketing for several indications, and this is only a new one," he said. "The product is registered for treating AAT deficiency in the US, Brazil, Argentina, and Israel, and we believe that at least in some of these markets, we can go directly to advanced studies and concentrate our resources there."
The AAT protein already has FDA orphan drug status, which will facilitate registration of the drug, but the FDA's procedures are also stricter than elsewhere, and Kamada may not first launch in the US. Kamada's distribution agreement with Baxter International Inc. (NYSE: BAX) for Glassia can be expanded to the AAT protein for diabetes. If Baxter exercises its option to market the drug in the US, it will assume most of the cost of a US clinical trial.
Kamada also asked its general shareholders meeting permission to publish its financials in English, apparently ahead of a Nasdaq listing. Although the company has been preparing for a listing in recent months, no date has been set. "We don’t need to raise capital at the moment to complete our main clinical program," said Efron. The company had $34 million in cash at the end of 2012.
Tsur's salary was $858,000 in 2012, half of it in shares. He is eligible for a 2% bonus of any public offering, up to a cap of $1 million.
Earlier this year, Kamada announced that its employees had unionized, making it the first TASE-listed life sciences company to do so. "We received the request, and we're in talks with the workers committee," said Efron. "We don’t think that this will have a material effect on our financial statements."
Published by Globes [online], Israel business news - www.globes-online.com - on March 11, 2013
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