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Kamada's revenues for 2013 are projected to be $74 MM, reflecting expected continued growth in the Proprietary Products segment to $54 MM
This year, the company will complete its phase 2/3 clinical trial in Europe to treat AAT deficiency, it will start a phase 2 clinical trial in the US with the same product, and it expects to start a Phase 2 or phase 2/3 clinical trial to treat newly diagnosed type-1 Diabetes
Adjustments made in the manufacturing process for the AAT product, when approved, are expected to allow the company to increase manufacturing capacity
Ness Ziona, Israel, April 2, 2013. Kamada, Ltd. (TASE: KMDA), an orphan drug focused, plasma-derived protein therapeutics company with an existing marketed product portfolio and a robust late-stage product pipeline, announced today that its forecast for 2013 revenue is to be approximately $74 million, compared to $73 million of revenue for 2012. Kamada expects continued growth in its Proprietary Products segment sales, which include sales of Glassia, which are expected to increase to $54 million in 2013, compared to $47 million in 2012. Profitability in the Proprietary Products segment is higher than in the Distribution segment (which is comprised of imported products), and this shift reflects the actions that Kamada has taken to implement its strategic plan to increase the portion of revenue from the Proprietary Products segment over revenue from the Distribution segment, which is expected to improve the overall profitability of the company during 2013.
With respect to product development, Kamada reinstates that by the end of 2013, it expects to complete the phase 2/3 clinical trial in Europe to treat Alpha-1 Antitrypsin deficiency (AATD) through inhalation and is planning to start a phase 2 trial in the US for the same product this year. The company believes this, together with the results of the European clinical trial, will enable it to apply for marketing authorization in the US. In addition, the company is preparing to start a phase 2 or phase 2/3 clinical trial this year to treat newly diagnosed type-1 Diabetes with its intravenous AAT product.
In the recent past, Kamada has undertaken certain activities to increase the production capacity of its manufacturing facility in Beit Kama in order to prepare for future increases in the demand for the AAT product in different indications, if and when approved. As part of these activities, Kamada updates that, in addition to the current manufacturing processes for Glassia, the intrevenous AAT product to treat AATD, the company designed and implemented adjustments to its manufacturing processes to improve significantly the manufacturing capacity of the AAT product, and that a request for approval of these adjustments from the FDA was filed. The FDA has since responded to this request by requesting additional data. Kamada intends to submit its answers to the FDA's additional data request during the second quarter of 2013 and will continue to use its existing production process in the interim and not distribute any inventory produced by the new process. Kamada estimates that as a result of the timing of Baxter's orders for Glassia and Kamada's expected timetable for receiving FDA approval to the manufacturing capacity growth (expected during the second half of 2013), revenue from Baxter will mainly be recognized during the second half of 2013. The company believes that there is a high probability of FDA approval of the improved manufacturing process, which is based on Kamada's unique technology and which has already been implemented with respect to the existing FDA-approved manufacturing process in the company's factory in Beit-Kama, although no assurances can be provided.
In addition, Kamada have conducted during the last couple of years, investments of millions of dollars to establish an additional logistics building as part of our preparation to meet with the demand for the AAT products.
Kamada emphasizes that its 2013 revenue forecast is not based upon an assumed approval of the improved manufacturing process in the US. If and when the process is approved, it is expected to contribute to increases in the company's gross margin and operational margin mainly beginning in the second half of 2013 and mainly from 2014 onwards. Until such approval, the company continues to produce based on the approved process.
David Tsur, Kamada CEO, noted that: “Kamada is expected to show continued sales growth in the Proprietary Products segment. We predict that the number of patients using Glassia will continue to grow in the next year and Kamada and Baxter are ready to support the market's needs. We are excited about the AAT's expanded potential applications in a variety of orphan diseases, including AAT inhaled to treat AATD and newly diagnosed type-1 diabetes. This year we start some exciting clinical studies that could serve as future growth drivers for Kamada.”
Kamada is committed to improving its profitability and in doing so we have conducted, during the last couple of years investments of millions of dollars to establish an additional logistics building as part of our preparation to meet with the demand for the AAT products. During the third quarter of 2013, we intend to kick off operations in the new building that will aid us in continuing to expand our storage space and sales capacity.”
We are an orphan drug focused, plasma-derived protein therapeutics company with an existing marketed product portfolio and a robust late-stage product pipeline. We develop and produce specialty plasma-derived protein therapeutics and currently market these products through strategic partners in the United States and directly, through local distributors, in several emerging markets. We use our proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (‘‘AAT'') in a high purity, 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 immuno-modulatory, anti-inflammatory, tissue protective and antimicrobial properties. Our flagship product, Glassia, is the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the United States Food and Drug Administration (the ‘‘FDA''). We market Glassia through a strategic partnership with Baxter International Inc. in the United States. Additionally, we have a product line consisting of nine other injectable pharmaceutical products which are marketed, in addition to Glassia, in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia. We currently have five plasma-derived protein products in our development pipeline, including an inhaled formulation of AAT for treatment of AAT deficiency that is in pivotal Phase II/III clinical trials in Europe and entering into Phase II clinical trials in the United States. In addition, we leverage our expertise and presence in the plasma-derived protein therapeutics market by distributing ten complementary products in Israel that are manufactured by third parties.
Additional information is available at www.kamada.com.
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Cautionary Note Regarding Forward-Looking Statements
This release contains forward-looking statements that involve risks, uncertainties and assumptions, such as statements regarding the US FDA approval of our new Glassia production processes, projections of our future operating results, timing of clinitcal trials, expected increases in production output due to new production processes, timing of expected revenues from Baxter, and the growth in the number of patients treated by Glassia. 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, delays or denial in the US FDA approval process, additional competition in the AATD market, further regulatory delays, delays in implementing our new production process, and failure to obtain the expected yields in our new production process. The forward-looking statements made herein speak only as of the date of this release and the Company undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.