THE WALL STREET TRANSCRIPT |
||
|
Questioning Market Leaders For Long Term Investors |
L. WILLIAM MCINTOSH - NEXELL THERAPEUTICS INC (NEXL) DOCUMENT # KAC629 L. WILLIAM MCINTOSH has served as President and Chief Operating Officer of Nexell Therapeutics since March 1, 1998. From May 1997 through February 1998, he served as Senior Vice President of Business Development and Finance and Chief Financial Officer of the c ompany. Prior to joining Nexell, Mr. McIntosh served as Senior Vice President of Business Development and Commercial Operations for Zynaxis Inc., a biotechnology company with both drug delivery and diagnostic technologies. Mr. McIntosh has served in senior management positions at SmithKline Beecham (as a full-time consultant), Boehringer Mannheim Pharmaceuticals Corporation, Medco Containment Services, Inc., and Merck and Co., Inc. He currently serves of the Board of Directors of VIRxSYS Corporation. Mr. McIntosh earned a BS in Business Administration and an MBA from Lehigh University. Sector: biotechnology TWST: Could you begin by giving our readers an overview of Nexell Therapeutics? Mr. McIntosh: Nexell Therapeutics is the leading developer and marketer of innovative ex vivo cell therapies and in vitro diagnostics for cancer, autoimmune, metabolic and genetic diseases. We're the only company marketing clinical stem cell technology in the US. We have a broad patent portfolio and limited direct competition worldwide. Indeed, our patent portfolio gives us a very strong position here in the United Sates. The Company was formed through two acquisitions that we made. The first was in late 1997, when we acquired the Immunotherapy Division of Baxter Healthcare, Incorporated. And then, roughly a year later, we acquired substantially all the assets of CellPro, Incorporated. So we are, essentially, the combination of those two companies and that's why we have the leading position in the world in the development of cellular therapies. TWST: What is stem cell technology and cell therapy? Mr. McIntosh: Stem cell technology and cell therapy, as we practice it, is the selection, manipulation, expansion and use of cells to achieve a particular therapeutic end. The major cell type that we concentrate on today is the hematopoietic stem cell, or, quite simply, the blood and immune system stem cell. It's known in shorthand as the CD34 stem cell. This cell is, essentially, the master cell that creates all the blood and immune system components in the body. Now what we do, at least in the initial application, is use our instrumentation, our plastic disposables, and our biological reagents to capture these stem cells from cancer patients before they undergo high dose chemotherapy. Those cells are then re-infused into the patient after they receive treatment to restore the blood and immune system, which were essentially destroyed by the high dose chemotherapy. The beauty of this process is that our technology not only captures the right cells to rebuild the immune system, but it also eliminates cancer cells that are in the transplant graft. So those cancer cells are not re-infused into the patient and, therefore, you've reduced the chances of re-seeding the cancer. So we do two things. We pull out those cells that are needed to rebuild the immune system following high dose chemotherapy, and we eliminate unwanted cells, particularly tumor cells, that are present in the transplant graft. TWST: Would this be a treatment for all types of cancer? Mr. McIntosh: There are a number of cancers that use high dose chemotherapy and, therefore, need these stem cell transplants that we've been talking about. The major ones are the leukemias, lymphomas, multiple myeloma, breast cancer, and the like. TWST: What direction would you want to take Nexell Therapeutics over the next few years? Mr. McIntosh: In the near term we're looking to expand the utilization of stem cell selection, our current revenue driver. We received approval for our major stem cell selection system, the Isolex' 300i, about the middle of last year, so we're really still in the launch phase, if you will, for this product. So we're looking for some solid revenue growth in that area. We continue to improve our selection platform and to pursue regulatory approvals in new markets. We have just received US approval on our latest enhancement for the Isolex', our version 2.5 upgrade for the positive selection system. And we've also just received regulatory approval in Australia. We've just announced a major distribution agreement with Takara Shuzo, covering Japan, China, Korea and Taiwan. So our cell therapy products will soon be available in many of the most important markets around the world. In terms of things moving forward in the research and development front, we're looking to significant advances in the treatment of important diseases beyond cancer over the next few years. For example, researchers in France recently showed that they could use some of our technology to create a gene therapy for the 'boy-in-the-bubble syndrome,ý properly called Severe Combined Immuno-deficiency syndrome (SCID). We expect to see some significant progress in the development of cell therapies for treating end-stage autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and systemic lupus, among others. We're also looking at some early programs that would involve the use of stem cells to help in the process of solid organ transplant. Researchers have discovered that if they transplant stem cells from the donor to the recipient, that it can improve both the take rate, if you will, of the organ and reduce or eliminate the need for immunosuppressive drugs following the transplant. So there are a large number of major research and development opportunities that we see for our technology over the next three to five years. TWST: You referred to the take rate ' do you mean the acceptance of the organ? Mr. McIntosh: Yes, exactly. Generally, the acceptance of the organ is very high now, but that is simply because organ transplant patients are given fairly massive doses of immunosuppressive drugs to prevent organ transplant rejection. Of course the problem with immunosuppressive drugs, other than the fact that they're expensive, is that the patient is then, for the rest of their life, exquisitely sensitive to infections of any kind. So they are constantly battling the balance between having enough immunosuppressive drugs on board to keep the organ from being rejected, and risking life-threatening infections. What has been discovered in the laboratory and now in the clinic, is that if you transplant stem cells along with the organ, you can virtually eliminate the use of immunosuppressive drugs, and at the same time, have a successful transplant. But again, this is just one of the many, many exciting areas that we're seeing unfolding over the next three to five years. TWST: Would that involve heart transplants, liver, kidney? Mr. McIntosh: Right. Any sort of organ transplant, in theory, could use this approach. TWST: What about bone marrow? Mr. McIntosh: Bone marrow transplant is sort of the old way of doing things. In the early days of high dose chemotherapy, they used bone marrow to transplant stem cells because that's where you found stem cells. The new way of doing it is to use a mobilization drug, usually G- CSF, which drives the stem cells out of the bone marrow into the peripheral blood where they can be collected more easily. Because of mobilization, we can collect stem cells in an outpatient procedure called apheresis that is not unlike blood donation in a typical Red Cross setting. TWST: What do you see as the biggest opportunity for Nexell? Would that be the development of the 2.5 Isolex'? Mr. McIntosh: Certainly, we view the Isolex 300i 2.5CE, which actually was launched last fall in Europe, as the next evolution of our technology. It allows for extremely high purities and yields of cell products and, in the version available in Europe, also allows for both positive and negative selection in one single run. Positive selection is when we take out cells that we want to use in a patient, such as the stem cells. Negative selection is when we actively target and purge cells that we don't want, such as the cancer cells. With our new 2.5CE system, we can do positive-negative selection in a single run. There's no other instrument in the world that can do that. TWST: As far as the business aspects of Nexell, will acquisitions or mergers play a role in the company's future? Mr. McIntosh: We think mergers and acquisitions are an important way to continue to add to our technology base, our patent position, and expand our footprint in the world of cell therapies. While we do have the broadest commercial offering of any company out there, including a full line of products for tumor cell detection, cell selection, expansion and manipulation, and storage, we believe there are other important technologies that are being invented and discovered. For us to continue to broaden our base, we probably will seek to do some strategic mergers and acquisitions. TWST: What do you see as the rate of gain in sales and earnings over the next few years? Mr. McIntosh: It is a little difficult to predict because quite frankly, this is a brand new market. It's not one of those markets that is already established and therefore, easily predicted. We're certainly looking for double-digit growth in our sales over the next two years and to the extent that we see some of these new applications that we've talked about coming into more routine medical practice, we would expect to benefit from those developments also. TWST: What would you say about your research team and your management team? Would you say that you have a pretty sound management team and research team? Mr. McIntosh: No question about it. Since we made the initial acquisition back in late 1997, we've been working to build our management team. We have added a number of new members to that team quite recently, including a VP of Marketing, Lew Chapman, who has extensive experience in pharmaceutical, biological and medical device marketing, and a new VP for Business Development, Michel Bergh, PhD. Dr. Bergh also has extensive experience in both pharmaceutical and biotechnology worlds, including former positions at Genzyme, Schering, and several West Coast biotech companies. Both of these gentlemen make great additions to what has turned out to be a first-class team that we've built over the last two years. TWST: As President and COO, where do you spend more of your time within the company? Mr. McIntosh: Speaking of the team, I've spent a lot of my personal time over the last two years building this team. In addition, the two most important activities for me are fundraising and strategic planning. We did have a successful effort late last year and raised $63 million for the company. We've also worked hard to lay out the strategic vision for the company and drive the company to that strategic vision. TWST: Raising $63 million is certainly no small accomplishment. Mr. McIntosh: I agree, and we did it, quite frankly, before the biotechnology market came into vogue late last year and early this year. I'm really quite proud of that financing because we brought in four of the biggest names in the world of insurance, led by John Hancock, to invest in Nexell Therapeutics. I think their investment helped validate our business to many other investors. They looked at this company very, very closely and decided to invest based on the fundamentals and where they see this company going. TWST: What are the primary factors that affect your operating margins? Mr. McIntosh: The largest cost for us is research and development. We spend, in round numbers, close to $20 million a year, if you look at all our research, development, clinical trials, regulatory affairs, and so forth. But this is the engine that's going to drive new products and drive the future of the company. So we think it is well spent. The second largest cost or line item for the company is marketing and sales. We originally had an agreement where Baxter was doing our end market selling. That was changed last year, and so late last year and early this year we're essentially building our own sales and marketing team here, both in the US and Europe. And, of course, that represents a fairly substantial cost item for us. But we think, again, that's a well- placed expense because we now have control of our entire business from the research and development laboratory to the end user customer. TWST: What two or three reasons would you give potential long-term investors for investing in Nexell Therapeutics? Mr. McIntosh: I think the first reason is that cell therapies represent a whole new medical paradigm. If you look at some of the important major advances in the field of medicine, such as antibiotics or monoclonal antibodies, these represent revolutionary developments in the use of science and technology to advance medicine. This is what cell therapies have the potential to do. The use of living cells as therapeutics is a major medical advance. So we're operating on the leading edge of what we view as an important change in the way this technology will be used. Secondly, I would say that we are the most important player in this field. As I mentioned, we have acquired a number of companies, a large asset base, an extremely broad patent portfolio, and we have a full line of products from cell selection devices, to storage devices, to manipulation devices, to in vitro diagnostics. So we have a position in each of the important segments of this market. Quite frankly, we have the largest position of anyone in the market. Thirdly, we're not just a typical biotechnology company that sort of is spending, spending, spending on research and development with the hope that something will happen in the future. We have revenues today. We expect to see our revenues grow over the next few years, so we can look forward to a day when this company can stand on its own from a P&L standpoint. Last, but not least, I think we have an opportunity to do some important mergers and acquisitions, to bring in and enlarge our portfolio of technologies, giving us an even more dominant position in this emerging field. TWST: So there is some competition in the field, but it's still a relatively new and you are ahead of the pack? Mr. McIntosh: We're clearly the leader in the field. There is limited competition. As I said, because of our patent portfolio, we are very competitive with our most important product lines here in the US. And we only have one, small, private company that's a direct competitor in Europe. There are a number of other companies that are sort of peripheral to our space, but we really have a dominant position in the marketplace around the world. TWST: Is there anything we may have missed or overlooked that you might want to discuss before we conclude the interview? Mr. McIntosh: I might point to some important milestones that our investors can look forward to in 2000 and beyond. We should mention that we made a proposal to our shareholders to rationalize our capital structure with a reverse split. This is an important activity for us and, of course, unusual because this isn't done very often. But we're trying to reduce the total number of shares outstanding to try to reduce some of the volatility in our share price ' and attract long-term investors to the company. Again, we'll be looking for revenue growth over the next few years. We're continuing to actively pursue win-win partnerships with large pharmaceutical and other biotechnology companies, so people should watch for announcements in those areas. Of course, we continue to either acquire, or through our own research and development, invent innovative technologies that add to our intellectual property estate and product offerings. TWST: Thank you. L. WILLIAM MCINTOSH President & COO Nexell Therapeutics, Inc. 9 Parker Irvine, CA 92618 (949) 470-9011 (949) 586-2420 ' FAX Each Executive who is the featured subject of a TWST Interview is offered the opportunity to include an Investors Brief or other highlight material to be provided and sponsored by and for the company. This interview with L. William McIntosh, President & COO, of Nexell Therapeutics, Inc., is accompanied by an Investors Brief containing corporate information. Copyright 2000 The Wall Street Transcript Corporation All Rights Reserved The Wall Street Transcript (TWST) interviews are published verbatim, and TWST does not in any way endorse or guarantee the accuracy of any information or opinions expressed herein and all opinions are subject to change without notice. Nothing herein constitutes a solicitation to buy or sell any securities. TWST interviews with CEOs may include include "forward-looking statements", which are based on factors that involve risks and uncertainties. Actual results may differ materially from those expressed or implied. TWST shall have no liability whatsoever for any trading losses arising out of use of this information. Copyright 1999 Wall Street Transcript Corporation. All Rights Reserved. |