David Green
Analyst · R.W. Pressprich
Thank you, Chane, and good morning, everyone. We're very pleased to report the success of the regenerated trachea transplant in the 2.5 year old girl, Hannah Warren, at Children's Hospital of Illinois announced on Tuesday this week. This procedure saves her from certain death and gives her a chance at a relatively normal life. This was the world's first pediatric transplant of a regenerated trachea using a synthetic scaffold. It was also the first in the U.S. and, hence, the first approved by the U.S. FDA. For us, it was also the first use of a scaffold made by us. The news of this transplant was reported in most major media outlets in the U.S., including on the Today Show, on NBC, the ABC and CBS Evening News and on the front page of The New York Times. NBC has told us that they plan to air an extensive documentary hosted by Meredith Vieira covering the entire story of the transplant later in the year. Because of the surgery has to be approved by the USFDA, we compiled extensive documentation of the scaffold and bioreactor system and submitted this data via Dr. Holterman, the principal investigator for Hannah's surgery, to the FDA. The FDA approved the use of our products under investigational new drug application. We intend to build on this successful FDA review of our products by approaching both the FDA and the European regulatory authorities within the next few months to agree a clinical trial plan aimed at obtaining approval to sell the products and enable many more patients to be treated using regenerated tracheas. In addition to this significant clinical milestone, I'm also pleased to report on the progress of the other patients treated with regenerated tracheas. The very first patient, Claudia Castillo, is now approaching her 5-year anniversary. Mr. Beyene is approaching his second anniversary, and the 2 Russian patients are approaching their one-year anniversaries. This is very encouraging data that will help support our submissions to the regulatory agencies. In addition, we expect further surgeries using our InBreath scaffold and bioreactor system, all under compassionate-use rules, to take place this year. At this point, the technique is still experimental and can only be used on humans when investigational device regulations have been followed. Last evening, we announced our plans to move forward with the separation of HART from HBIO. We believe that separating the HART business from the Harvard Bioscience business via a spinoff of shares will maximize value for Harvard Bioscience shareholders for the following reasons: We believe the Harvard Bioscience shareholders will benefit from owning shares in the 2 separate companies by having the continued earnings and cash flow generation of our core Life Science Research Tools business reflected in one security, the common stock of Harvard Bioscience, and the longer-term future potential of the regenerative medicine business reflected in another, the common stock of HART. The $15 million contribution to HART from Harvard Bioscience will provide funding for HART to advance the trachea transplant product into clinical trials. The immediate listing of 100% of the shares of HART will create significant liquidity in the HART stock. The spinoff will remove the HART operating losses, which were approximately $6.3 million in 2012, from the Harvard Bioscience income statement making the profits of the Harvard Bioscience business much more visible. The spinoff will give Harvard Bioscience greater borrowing capacity and will allow Harvard Bioscience to focus more aggressively on our core business's acquisition strategy after the spinoff. Our recently expanded credit facility will give Harvard Bioscience the ability to fund this acquisition strategy. And finally, Harvard Bioscience will retain the tax loss carry forwards generated by the historical investment of approximately $12 million in HART, which will reduce the income tax payments in a few years after the separation, which will improve Harvard Bioscience's cash flow even more than just removing the HART operating losses. This revised spinoff process requires the SEC to declare our Form 10 registration effective, and we anticipate this process, together with the NASDAQ listing process and updates to the IRS private letter ruling, could take up to approximately 4 months. We'll now open up the call to any questions.