J. Katzaroff) This is one of the critical issues the U.S. has been dealing over the last few years. HEU (highly enriched uranium) is banned in the US as it is essentially bomb material. However, not every county has made this decision. Russia is changing from HEU to LEU (low enriched uranium) sometime in the near future. One of the differences between HEU and LEU for radioisotope production is that the latter adds cost and time, which some of the countries may not be willing to sacrifice.
(CF) What do you need to accomplish before you can start selling this in U.S.?
(J. Katzaroff) ADMD will obtain samples from the Russian reactors soon for a 3 month testing process. The FDA will test three separate batches which can be done simultaneously. ADMD could possibly have three sets in in the next few weeks to begin processing. This initial testing and validation is required before these products can be sold in the U.S.
(CF) So far we have only focused on the isotope and generator business, what about other products that GSG and ADMD are collaborating on?
(J. Katzaroff) As I mentioned before, this is quite a far-reaching alliance between the two parties where we want to be able to leverage each other’s capabilities. That includes, but is not limited to, joint manufacturing facilities, irradiating medical devices, nuclear waste cleanup, and moving forward on intellectual property pursuits, including our patents on turning nuclear waste into medical isotopes.
(CF) Mr. Katzaroff, I certainly appreciate you taking time out of your busy schedule to answer some questions for shareholders. It appears that Advanced Medical Isotope Corporation is making wise decisions not only for its future profitability, but also for its investors’ interests. I look forward to seeing your company continue to grow and potentially help fill a very real market need for radioisotope production. With shares trading down at the current range of about $0.12, the upside could be promising...
The dollar amount expected to come from Mo-99 sales in Russia this year may be a little over $8 million, with that reactor working only at reduced capacity. As additional reactors in Russia are gearing up to Mo-99 production, redundancy and reliability is critical for global acceptance of Russian Mo-99. The sales are projected to grow 7x over the next two years. Of course, testing and approval for sales here in the U.S. are critical factors. What everybody wants is reliability.
(CF) Nordion Inc. (NYSE:NDZ) and Covidien (NYSE:COV) are generally considered to be the headliners as investment candidates in medical isotopes. Could you give us a projection on isotope sales in the short term and long term associated with ADMD’s GSG agreement?
(J. Katzaroff) Total market in world is 12,000 curies/week of Mo-99, and about half of that is used by the U.S. when it can be obtained. The current pricing of long term contracts appears to be $400-$600 per curie, and with shortages, spikes could be as high as $1700/curie. This translates into $350-$400 million annual revenue. A 10% share of the U.S. isotope market alone would be worth around $18-20 million per year. Not to be left out of the equation, investors should also note that China’s booming growth will likely increase its demand for medical isotopes, likely rivaling that of the U.S. demand in coming years. In all scenarios, a reliable source of isotope supply could easily obtain a significant part of this pie.
(CF) What about transporting from Russia to here with isotopes decaying so rapidly?
(J. Katzaroff) The half life of Mo-99 is about 6 days, which makes it transportable from or to anywhere in the world. This is typically a non-issue regarding source of production.
(CF) With nuclear proliferation being high on the international agenda, what about the potential ban on highly enriched uranium for any medical isotope production? How could that impact the supply?
This recent press release, combined with the company’s low market capitalization prompted me to contact CEO James Katzaroff about the company’s future and what its plans are for 2013 and beyond. He was gracious enough to answer some key questions pertaining to the new alliance that I thought the investment community could find useful when considering the company as an investment. Following are Mr. Katzaroff’s responses:
(CF) What is the value of the GSG alliance for ADMD and for its shareholders? Can you please describe what this agreement is about in a bit more detail?
(J. Katzaroff) Gamma Service Group (GSG) has been around for 20 years and is well known for making high quality equipment for Mo-99 isotope production. The company has access to generator equipment as well as many other items for use in the nuclear medicine field. GSG is also working on manufacturing the generators and Tc-99m disposable kits to go along with the equipment that the company already markets. It also specializes in building customized hot cells and irradiators. The company generates an impressive $45 million in revenue with nine affiliated companies, and ADMD has the right to sell this equipment and related kits in various geographies. We are in discussions with several of these units for major collaborative efforts.
ADMD has secured rights to distribute in China as well as North and South America for all technologies and products related to Mo-99. In addition, ADMD would be able to compete for distribution in the rest of the world. One of the big problems in the U.S. in the past few years have been an uncertain and sometimes diminished supply of Mo-99 which is critical for medical applications for medical diagnostics and therapeutic applications. GSG has outstanding relationships with Mo-99 producers throughout the world, particularly the reactors in Russia which are gearing up to be able to produce on a global scale.
I believe RadioGel is a pioneering technology in the brachytherapy sector because it holds marked clinical advantages over traditional implants. Specifically, RadioGel's list of clinical advantages include but are not limited to the following:
- Yttrium-90 has a half-life of only 2.7 days
- Yttrium-90 has considerably clinical evidence showing efficacy against inoperable liver tumors
- Ytrrium-90 has shown promise in reducing tumors in a variety of cancer types
- Yttrium- 90 is a beta-emitter, making it safer for clinicians and patients alike
- No metal casings to deal with
- Gel is biodegradable and can thus be easily reabsorbed by the body
- Gel forms a solid lattice that holds the Yttrium-90 in place and is thermally reversible
To put this into context, I believe that patients given a choice between a surgically implanted medical casing with a long-lived isotope such as iridium-192 or a gel that dissolves in a few days, the patient is going to choose RadioGel every time. Given that the clinical research thus far is painting a promising picture for yttrium-90 in a diverse array of cancers, I believe RadioGel has a strong chance to become the standard of care in brachytherapy procedures. Unfortunately, I wasn't able to get an estimate on the timeframe for FDA review of RadioGel, but instead was informed by the agency that they cannot currently comment on a device that is "under-review". Based on historical precedence, however, I think RadioGel could be approved before the end of 2013.
Sentiment: Strong Buy
I just wanted you to know of the company Advanced Medical Isotope corporation (ADMD)-- they have just initiated pre-review with the FDA for their product RADIOGEL. Please look into this company because I believe you will make good gains from it!
Sentiment: Strong Buy
Good news that the FDA is now involved in reviewing radio gel. this is the first step in where the company begins process to market and produce radio gel. bravo!
Sentiment: Strong Buy
Wonderfully analyzed and written. I am glad to see the expaned coverage on ADMD.
Sentiment: Strong Buy