BIOM AGM Transcript, Part 1 of 2:
A lousy day today. So though I'd vowed to stay away from all things electronic....well....here I am. Heh! Anyway, DC_Campbell over on Yahoo did a great stenographers job of creating a transcript for future reference. I thought it'd be a good idea to include it here as well:
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Mr. Baker: Dr. Alex McPherson, our President and Chief Executive Officer will now speak to the meeting and describe Biomira's progress and achievements over the past year.
Dr. McPherson: It's kind of tough for a guy who's used to chalk. Good afternoon ladies and gentlemen, thank you very much for coming to Biomira's annual general meeting here in Toronto. We usually start by mentioning that that's Black Baker, after our chairman Eric Baker and then remind everybody that's also Edmonton and that's the only day of the year when the fountain is actually working. This cautionary statement needs to be taken seriously as it always does, of course, because we are being web cast, as we speak, and therefore the accounting of today's presentation is being widely disseminated and widely disclosed. And today's presentations will contain forward looking documents or statements and for a complete account of our official corporate documents you are encouraged to review document files with the securities regulators.
2000-2001 was an outstanding year for Biomira.
We accomplished an enormous amount and although each little piece might not seem like an enormous amount, when you take it in totality it really has been an exceptional year for us. We've been able to establish fast track status with the FDA for Theratope vaccine, which essentially means that the product, if it fulfills its statistical requirements, is recognized as for life threatening conditions and unmet medical needs, and could lead to a priority review in relationship to its approval process.
We've secured additional financing for the company up to US $100 million, as of February 2000. We've had three successful Data Safety Monitoring Board reviews, at the 300 patient, the 600 and the 800 patient date, and these have been very successful. We've completed enrollment for Theratope, our vaccine phase III trial, in March of 2001. We've initiated our phase IIb clinical trial in non-small cell lung cancer, the smoker's cancer, with BLP25 vaccine, our follow-on vaccine. We've enormously strengthened our patent position and I'll go into that. We've completed enrollment in our phase II BLP25 and liposomal IL-2 trial. And for the rest of the presentation, BLP stands for Biomira Liposomal Peptide 25 and L-IL-2 stands for Liposomal IL-2. And we established an exciting corporate alliance with Merck KGaA.
This program, this collaboration, this co-promotion for Theratope and Biomira's Liposomal Peptide is unquestionably one of the largest in the world. It really needs to be seen in perspective and I'm going to try to take you through this agreement to the extent that it's possible, given the constraints that we're under, in relationship to the collaboration agreement.
It totaled, in relationship to upfront payments, and I'll talk about what I'm including here, represents in excess of US $150 million, in terms of Theratope vaccine and the BLP25 vaccine. And that's excluding, that's excluding, it's critical that you understand that, shared development costs, the net present value of future royalties, the new present value of the US co-promotion, royalty payments and sales milestones.
So there's an awful lot that we are looking at which is probably at least a trebling of the total value of this deal even looking at it conservatively in relationship to what is excluded and what is included. Now, what is included? What is included is an upfront and equity investment totaling approximately $33.7 million Canadian or $22 million US. That is the equivalent of about 75% of our 2000 burn rate. That is a very significant upfront contribution from Merck KGaA to the program in relationship to us moving those two product candidates forward.
In addition, milestone payments related to BLP25 and Theratope for first and second cancer indications, upon BLA submissions and regulatory approvals and finally sales milestones are included in the $150 million plus deal that we're talking about with Merck KGaA.
Now, what is this deal? Merck KGaA is the founding company of Merck & Co. of the United States. It is an enormously well recognized pharmaceutical, chemical entity in the United States. It probably places about 21st in the listing of pharmaceutical companies in the world. It was required to abandon its association with Merck & Co. following the second World War and it has a co-promotion with EMD, which stands for E. Merck Darmstadt Pharmaceuticals and this co-promotion that we will have, which is a sharing of revenues in the United States with EMD will have an independent Biomira sales force. And the proceeds from the US and Canadian sales are on an equal share basis, not only are they on an equal share basis but they allow Biomira to participate in sales, manufacture, marketing and distribution, so that we can forward integrate as a bio-pharmaceutical company based here in Canada.
In addition, Merck KGaA will equally share development costs, retroactive to January 1st, 2001 related to Theratope and BLP25. Merck will provide us with rest of world royalties, double digit, industrial norm, solid royalties. They will be responsible for rest of world clinical trial costs and they will be responsible for development and marketing outside of the United States, with the exception of Israel and the Palestinian Autonomy Area. They will provide, as I said, upfront cash and equity payments as well as milestone payments. We will be responsible for Canadian marketing, Merck will be responsible for paying us, in relationship to that Canadian marketing and they in turn will receive an equal share of sales. We will be responsible overall for manufacturing worldwide and will receive appropriate transfer pricing reimbursement. And that's a critically important component to the overall deal.
End of Part I. |
