美國安進 (AMGN) 2004 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Good afternoon and welcome ladies and gentlemen to the Abgenix third quarter 2004 financial report and update conference call.

  • At this time I would like to inform you that all participants are in a listen-only mode.

  • At the request of the Company we will open up the conference for questions and answers after the presentation.

  • I would now like to turn the call over to Bill Ringo, President and CEO of Abgenix.

  • Please, go ahead.

  • - Pres, CEO, Director

  • Thank you.

  • Good afternoon everyone and welcome to Abgenix' third quarter 2004 review call.

  • I am Bill Ringo, the Company's President and CEO.

  • Before we begin, let me make a few obligatory comments reminding you that during the course of the conference call the Company may make projections or other forward-looking statements regarding future events or financial performance.

  • We caution you that such statements reflect only the Company's current expectations and that actual events or results may differ materially.

  • Please refer to the risk factors and cautionary language contained in the documents that the Company files with the Securities and Exchange Commission.

  • Including the Company's annual report on Form 10-K for the fiscal year ended December 31, 2003.

  • That report was filed on March 11, 2004.

  • For a description of the factors that may impact our results and the outcome of any forward-looking statements.

  • Thank you for joining us today.

  • And I'm delighted to be here as the new President and CEO of Abgenix.

  • Also on this call with me are;

  • Ward Wolff, our Chief Financial Officer, Dr. Gisela Schwab, our Chief Medical Officer, Dr. Jeff Davis, our Chief Scientific Officer, and Gayle Mills, Our Senior Vice President of Business Development, and Ami Knoefler, Senior Director of Corporate Communication and Investor Relations.

  • During the call we will review our third quarter 2004 performance and provide an overall business update.

  • In particular, we plan to cover 2 important areas in the call today: The progress that we're making to advance our product pipeline and our current approach to managing resources.

  • Let me begin with a summary of developments during the quarter.

  • One of my first actions as the Abgenix new CEO and President was to hire Ward Wolff as our Chief Financial Officer.

  • A critical position that had been vacant for some time.

  • Ward brings over 25 years of finance experience to the Company.

  • And we are extremely pleased to have him on board.

  • Since his arrival in mid September, Ward has been focused on the financial operations and strategic planning activities of the Company.

  • Also during the quarter, Abgenix and its partners have made progress with the 7 antibodies from our technology that are in clinical trials.

  • And we have also reported on several preclinical developments.

  • Importantly, from our proprietary pipeline we presented 2 posters describing early clinical data for ABX 10241.

  • An antibody to parathyroid hormone.

  • They were presented at the American Society For Bone-Mineral Research annual meeting in early October.

  • The preclinical and early clinical findings from this program for secondary hyperparathyroidism are encouraging.

  • They support advancing this product candidate into a Phase I multidose study, which we intend to initiate by the first quarter of 2005 if not sooner.

  • We also saw important progress by our technology licensing and target sourcing partners.

  • This progress includes: Amgen's advancement of their fully human antibody, AMG 162, into Phase III studies for bone loss.

  • We reported an associated milestone in the quarter.

  • And hope to see future royalties should this fully human antibody from our technology be successfully commercialized.

  • Additionally, CuraGen has indicated plans to move CR002, the most advanced antibody from that collaboration into a Phase I study before the end of this year.

  • CR002 is in development as a potential therapeutic for kidney inflammation.

  • CuraGen has also announced that a second XenoMouse antibody from the CuraGen collaboration CR011 for malignant melanoma is expected to enter the clinic in 2006.

  • We expect to receive milestones as these 2 candidates progress through clinical trials and development.

  • We will be entitled to royalties on both products if they are commercialized.

  • During the quarter we also reported progress in our oncology collaboration with AstraZeneca.

  • Now concluding its first year. 12 antibody programs have been accepted into the alliance, meeting our goal for 2004. 4 of these programs were selected from our preexisting preclinical portfolio of oncology candidates.

  • Including 2 programs currently at the in vivo stage of preclinical evaluation.

  • Most importantly, Abgenix expects to receive reimbursement payments from these programs as we initiate cell line development activities and IND-enabling studies.

  • Finally, several noteworthy preclinical publications about XenoMouse antibodies were published.

  • These include 2 preclinical abstracts about an Abgenix antibody targeting tumor necrosis factor, or TNF alpha.

  • The antibody known as 10131 has shown greater affinity and potency than certain currently available TNF alpha inhibiting antibodies.

  • These posters were presented in October.

  • And Gisela will describe later how this antibody fits in our overall preclinical portfolio.

  • Additionally, 3 preclinical abstracts related to panitumumab were presented at the NCI, EORTC AACR meeting in Geneva.

  • These abstracts further characterize the anti-tumor effect of EGFR targeting with panitumumab.

  • Now let me ask Gisela to give an update on our product portfolio and some of the recent developments in that area.

  • Then Ward will review our financial results for the quarter.

  • Gisela?

  • - Chief Medical Officer

  • Thank you, Bill.

  • Let me provide you with an update on both our clinical and preclinical portfolio progress starting with panitumumab.

  • Further, on the panitumumab front our co-development partner Amgen continues to accrue patients in the pivotal trials to support a third line monotherapy indication and potential VLA filing in the United States in the second half of 2005.

  • While accrual in the U.S. pivotal trial has slowed, we are encouraged by the pace of enrollment in the European pivotal trial.

  • This is a robust and controlled study which will provide relevant clinical experience with panitumumab.

  • Despite involvement challenges with the U.S. trial we believe that a second half 2005 VLA filing can be achieved.

  • And we are confident that Amgen is very focused on bringing this therapy with important potential advantages to cancer patients worldwide.

  • Third line monotherapy and colorectal cancer is the most advanced potential indication for panitumumab.

  • Since Bill's arrival we have had several discussions with Amgen about the longer term development strategy.

  • And we support our partner's strategy to expand panitumumab's use.

  • We also look forward to updating you on the ongoing Phase II studies including our ongoing trial in non-small cell lung cancer for which we hope to have results during 2005.

  • In the meantime, we anticipate the presentation of interim results at the ASMO conference later this week from our Phase II single arm study examining panitumumab with irinotecan based chemotherapy regimen, salts or sulfury.

  • That trial is fully enrolled and evaluates panitumumab administered with chemotherapy as a first line colorectal treatment.

  • At ASMO data will be presented on the first 19 patients who receive panitumumab in combination with the salts regimen.

  • We are encouraged by the findings to be shown at the ASMO meeting.

  • Keep in mind, however, that these data reflect the experience of panitumumab in a small number of patients given the salts regimen in the frontline setting.

  • Consistent with the evolving standard of care in this area, the second part of the study evaluates an additional 24 patients who have received panitumumab with sulfury chemotherapy.

  • We will look forward to presenting those findings at a future medical meeting.

  • Of course, Abgenix's product pipeline extends beyond panitumumab.

  • In our broader oncology portfolio we will be submitting the results of our Phase I single-dose, dose-rising study of ABX-MA1to AstraZeneca for review.

  • The study evaluates the safety and pharmacokinetics of ABX-MA1 in 19 patients with melanoma.

  • You will recall that we have included an option in our alliance with AstraZeneca for them to first review the data.

  • As we have indicated previously, the financial and other terms of any future development for ABX-MA1 have not yet been set.

  • We look forward to discussing the safety and pharmacokinetic data with AstraZeneca as they bring significant biological experience in this area.

  • You may anticipate an update on those discussions early in 2005.

  • Bill alluded earlier to our recent progress on the AstraZeneca collaboration.

  • Abgenix is conducting antibody generation, cell-line development and preclinical development activities for the 12 programs that have been accepted into the collaboration thus far.

  • We are particularly encouraged by acceptance of the 4 preclinical programs from our preexisting pre clinical portfolio which could help expedite the time lines to IND.

  • Beyond oncology, we expect to move ABX 10241, our fully human antibody to parathyroid hormone, into a multiple-dose study by the first quarter of 2005.

  • We remain focused on this program not only because of the targeted action of our antibody and encouraging Phase I data presented recently at the ASBMR conference but also due to the market potential.

  • Secondary hypoparathyroidism occurs in 65% of hemodialysis patients.

  • A population expected toe grow exponentially in the coming years.

  • As an antibody we believe this product candidate may have several commercial advantages, such as dosing, convenience and safety.

  • Given its potential we are actively pursuing the development of this proprietary product candidate.

  • Regarding our earliest stage programs we currently have 15 access proprietary programs at the antibody generation and preclinical phase.

  • By proprietary we mean those programs for which Abgenix retains at least 50% of the commercialization rights.

  • This includes several programs resulting from our co-development partnerships with Chugai, [Sosai], [Dendrean] and U3.

  • Our goal in the coming months will be to prioritize and advance those programs so that we expand our clinical pipeline.

  • The most advanced preclinical programs which are in the in vivo preclinical phase target primarily inflammatory diseases and oncology.

  • Earlier in the call, Bill referenced our recent publication around a high affinity antibody to TNF Alpha.

  • This exemplifies one of those proprietary programs that we would choose to partner for later development and commercialization given the high cost of reaching the physician/customer base.

  • Other programs provide opportunities for Abgenix and its co-development partners to advance product candidates against novel targets such as in the oncology space.

  • In summary, we estimate that 3 to 5 of the most advanced proprietary programs are potential IND candidates within the next 24 months.

  • We look forward to giving you more insight into our operating plans and internal product development goals in early 2005.

  • I will now turn over the discussion to Ward who review our financial results.

  • - CFO, Sr. VP-Fin.

  • Thank you Gisela and thank you everyone for joining our call today.

  • It's a pleasure for me to join the management team here at Abgenix and I look forward to interacting with you as we move forward and continue to build our product portfolio.

  • Following the close of the market today we released our operating results for the third quarter ended September 30, 2004.

  • You should all have a copy of that release.

  • Let me first review our statements of operations and then provide some comments on the balance sheet.

  • Revenues for the third quarter of 2004 were 3.4 million compared to 2 million for the same period in 2003.

  • For the 9 months ended September 30, 2004, revenues were 11.8 million compared to 10.5 million for the prior year period.

  • Contract revenues for the third quarter 2004 included a milestone payment from Amgen for advancing AMG-162, a XenoMouse derived antibody into pivotal clinical trials for bone loss.

  • Operating expenses were 45.4 million for the third quarter of 2004, compared with 45.million for the same period of 2003.

  • The majority of the third quarter 2004 research and development expenses related to the Company's proprietary clinical products, including panitumumab and ABX 10241.

  • The fluctuation in R&D and manufacturing start-up costs between quarters is primarily a function of clinical development programs and product runs applicable to a particular quarter.

  • The resulting net loss for the quarter ended September 30, 2004, was 42.4 million, or 48 cents per share compared to a net loss of 43.6 million or 50 cents per share for the second quarter of 2003.

  • With respect to the balance sheet we ended the third quarter with just over 230 million in cash, cash equivalents and marketable securities.

  • Net cash used in operating activities was 36.5 million for the third quarter and 112.1 million for the 9 months ended September 30.

  • Capital expenditures for the first 9 months of 2004 was 6.9 million compared to 27.6 million during the same period in 2003.

  • We expect our total use of cash in operations and capital expenditures to be approximately 140 to 145 million for the full year.

  • Which is within our previously stated guidance for operating use of cash and capital expenditures of 130 to 150 million.

  • Keep in mind that we expect our use of cash to decrease in the fourth quarter as we make additional draws on our $60 million credit facility from Amgen.

  • Our outstanding borrowings on the Amgen facility were 6.4 million at September 30, 2004.

  • On the financing front: we have intensified our long-term financial planning in conjunction with preparing our 2005 operating plan.

  • We have an active shelf registration that provides us with flexibility.

  • But we do not have immediate plans to issue common stock under it.

  • We are looking at a number of potential financing vehicles as part of our planning for managing liquidity going forward.

  • In parallel with evaluating our financing opportunities we remain focused on internal expense control and monitoring.

  • While we continue to actively seek appropriate manufacturing contracts for our plant; we think it is unlikely for a significant deal to be signed in the immediate future.

  • And we are planning accordingly.

  • In summary, we are committed to advancing our product portfolio while preserving a strong cash position.

  • We expect to summarize our 2005 plan and provide financial guidance during our next quarterly update call.

  • At which time we will report fourth quarter and full year results for 2004.

  • Bill, let me turn it back to you.

  • - Pres, CEO, Director

  • Thanks, Ward.

  • Before I open the call to your questions, let me make a few summary points.

  • As a management team, we're intensely focused on our budgeting process and planning process for 2005.

  • We are equally focused on making sure we execute against our 2004 goals, including the advancement of panitumumab and meeting our responsibilities in the Amgen collaboration.

  • I've had an opportunity to meet with the senior management of Amgen.

  • I'm excited about our partnership.

  • I'm excited about the plans they have in place, both commercially and clinically, to make sure that together we bring this important product to patients.

  • Another key priority is moving the ABX PTH program forward.

  • And at the same time advancing our preclinical candidates further in the pipeline.

  • And we must improve our overall operational efficiency as a Company.

  • We are in the process of taking a look at our corporate strategy and putting in place a strategic plan which will take us the next few months to do.

  • Once we have that in place we will be ready to share it with you at the time that it's completed.

  • We look forward to reporting back to you on our progress against our goals for this year during our February call and sharing with you at that time our '05 operating plan and goals.

  • Now Mia, I will turn the call back to you for questions from our audience.

  • Thank you.

  • Operator

  • [Caller instructions.] Your first question comes from Meg Malloy of Goldman Sachs.

  • Please proceed.

  • - Analyst

  • I was wondering, Gisela, could you elaborate a little bit more on the enrollment in the U.S. for panitumumab?

  • I know you said it's slow, which I guess is not new information.

  • But how does it compare to what your expectation would be at this point in time?

  • And how much wiggle room is there for a potential VLA submission in the second half of next year?

  • - Pres, CEO, Director

  • Meg this is Bill Ringo, your call was pretty soft but let me repeat the question, see if we've got it correct.

  • Whether we can comment further about the enrollment around the panitumumab trial?

  • And was there any additional information we could provide on that?

  • And I think maybe the statement of what wiggle room is there?

  • - Analyst

  • Yes.

  • - Pres, CEO, Director

  • In the submission?

  • Is that correct?

  • - Analyst

  • Yes, thanks.

  • - Pres, CEO, Director

  • Okay.

  • Let me just make a couple of high level comments and then ask Gisela to comment further, Meg to your question.

  • Clearly we have said ourselves, our partner Amgen had mentioned the slowness in the enrollment in the U.S.

  • But the fact that our European trial is pretty well on track we feel confident that we can still make our VLA submission, as Gisela outlined in her presentation.

  • I think, as you know, we have not given specific patient data in either one of the trials in terms of enrollment.

  • And would not be prepared to do so at this time but let me ask Gisela if she'd like to add anything to those comments.

  • - Chief Medical Officer

  • Bill, as you stated and as was stated before, the U.S. trial accrual has slowed.

  • However, the European pivotal trial is moving forward as planned and is on track.

  • And this is a robust randomized study that will provide important information.

  • We have at this point still - - we are maintaining our expectation and are very focused to prepare a VLA filing in the second half of '05.

  • So that is obviously indicating that we are thinking that the trial can be completed satisfactorily.

  • - Analyst

  • If I could just follow up on that.

  • Would you be prepared to file a VLA based on European data only?

  • - Chief Medical Officer

  • Meg, we cannot obviously comment on regulatory strategy at this point.

  • But I think it's important to understand that the European study is a robust randomized controlled study.

  • - Analyst

  • Great.

  • Thank you.

  • And if I could follow up one more with Ward.

  • Your use of cash, 140 to 145 million, does that include or exclude the Amgen cash drawdown?

  • - CFO, Sr. VP-Fin.

  • It's net of the Amgen cash drawdown.

  • As we've indicated in earlier calls and releases, that's the way it would be measured.

  • - Analyst

  • I thought so but just wanted to check.

  • Thanks a lot.

  • - CFO, Sr. VP-Fin.

  • Thanks, Meg.

  • Operator

  • Your next question comes from David Witzke of SunTrust Robinson Humphrey.

  • Please proceed.

  • - Analyst

  • Thank you for taking my call.

  • Question regarding the non-small cell long randomized Phase II, I believe 175 patients, should we think of time line for ASCO '05 as the most appropriate forum to disclose that data?

  • - Pres, CEO, Director

  • Gisela, go ahead.

  • - Chief Medical Officer

  • Sure.

  • We have not at this point settled on a medical meeting.

  • I think it's fair to assume in that 2005 results are expected.

  • But we haven't settled ultimately on the medical meeting at which the data will presented.

  • - Analyst

  • Given enrollment when it was completed could it be sooner?

  • Is there an opportunity sooner than ASCO?

  • - Chief Medical Officer

  • The enrollment accrual was completed about mid-year this year around ASCO time this year.

  • And the follow-up has to be taken into account so I think the guidance is towards results in '05.

  • - Analyst

  • And regarding the current activity at the manufacturing plant, does this make you view this asset - - the strategic use of this asset differently?

  • - Pres, CEO, Director

  • David, this is Bill Ringo.

  • I think if we look at that asset, I mentioned to you that we were beginning to undertake a look strategically across our Company in making any modifications in the strategic direction or strategic plan.

  • Obviously all of the assets that we have we're going to take a look at evaluating.

  • Clearly the manufacturing piece of that will be part of our evaluation.

  • But we're not prepared at this point in time, nor have we done or completed our analysis to make any comments beyond.

  • - Analyst

  • Understood.

  • And finally, if I may, regarding the AstraZeneca alliance; at what point do we believe the preclinical manufacturing and development activities at Abgenix will pick up such that revenues become, you know, more meaningful in the income statement?

  • And how do we think about time line to an IND in this collaboration?

  • - Pres, CEO, Director

  • Let me, David, ask Gayle Mills, our Senior Vice President Business Development, to respond to your question, please.

  • - Senior VP Business Development

  • This is Gayle.

  • And as you heard earlier, we're very pleased with the progress of the collaboration thus far.

  • And we have multiple early programs moving through the collaboration.

  • And particularly with AstraZeneca, including some of our preexisting preclinical programs, we expect this program to move along quite well.

  • We would expect that over the next year we would initiate activities.

  • Some of these activities including cell line development which would start to bring in modest revenues.

  • Of course, with this deal, the ultimate revenue achievement is going to be based on the number of targets that move through the collaboration and their progress through development.

  • So over time we would hope that these revenues would significantly increase.

  • - Analyst

  • And time line for --?

  • - Senior VP Business Development

  • I'm sorry, the IND time line?

  • Well as I've mentioned, we have some programs that are in the in vivo stage now.

  • So although we don't have an exact estimate we would hope that in the 2006, 2007 time frame we may have an IND filing, best case.

  • - Analyst

  • Thank you.

  • - Pres, CEO, Director

  • Thanks, David.

  • Operator

  • Your next question comes from Elise Wang of Smith Barney.

  • Please proceed.

  • - Analyst

  • Thank you.

  • Thanks for taking my question.

  • Gisela, could you describe in more detail the upcoming presentation at ASMO for the ABX CGF product?

  • Could you again remind us the design of that study and what type of data will presented on the first 19 patients?

  • - Chief Medical Officer

  • This is data emerging from the single line study in first-line colorectal cancer panitumumab was combined with irinotecan containing chemotherapy regimens.

  • The first part consists of panitumumab plus salts, irinotecan containing regimen, given via the salts regimen.

  • The second part of the study, which will not be presented at ASMO, is assisting panitumumab given in conjunction with sulfury.

  • So at the ASMO Conference, we will see data on the first part, panitumumab, given in conjunction with the salts regimen and the obvious end points are going to be presented, including safety and measures of efficacy including response rates.

  • - Analyst

  • Okay.

  • Then how many patients were enrolled in total in this study?

  • - Chief Medical Officer

  • The first part enrolled 19 patients and the second part 24 patients.

  • - Analyst

  • Okay.

  • And the dose regimen for the dose level and regimen for ABX EGF was?

  • - Chief Medical Officer

  • That was the same in all the Phase II studies presented thus far, which was 2.5 milligrams per kilogram per week.

  • - Analyst

  • Okay.

  • In terms of, I think you've always told us that you would all give us an update in regards to the pivotal studies as to when you have reached the conclusion of patient enrollment.

  • And if I recall, originally the target was going to be the end of this year.

  • Clearly that's not been pushed out.

  • But can you remind us, is that true about the European study as well?

  • Was the target the end of this year?

  • - Chief Medical Officer

  • Well, we haven't really provided any specific guidance as to the exacts timing of conclusion of accrual.

  • But I think guidance with respect to a expected VLA filing in the second half of '05 presupposes that the trials would be supporting this filing would be concluded.

  • - Analyst

  • Okay.

  • Thank you very much.

  • Operator

  • And your next question comes from Eric End with Merrill Lynch.

  • Please proceed.

  • - Analyst

  • Just wanted to follow up on a question relating to the manufacturing plant, because I thought your answer was somewhat interesting.

  • It sounds like all things are kind of on the table going forward.

  • I'm trying to get a sense as to really what the costs are associated with operating the manufacturing plant, number one.

  • Number two, what the market value could be of that manufacturing plant?

  • And then, number three, if that manufacturing plant were to be sold, how would that affect your partnership with Amgen given that that is your responsibility with ABX EGF?

  • - Pres, CEO, Director

  • A lot of questions there, Eric.

  • And I thought I prefaced it correctly by saying;

  • I think in any good strategic review, strategic plan, you're going to look at a number of assets you have.

  • And make sure that those assets are being deployed and helping you accomplish long-term strategic goals.

  • And we're not in any way, shape, or form far along with our strategic plan after my first just less than 2 months on the job so far being able to address the kinds of questions that you raise.

  • But I can assure you that when we are ready to we'll be prepared to share that appropriately.

  • - Analyst

  • Well, can you guys at least answer the question related to the costs associated with operating that plant?

  • - Pres, CEO, Director

  • Sure.

  • I'll let Ward take a shot at that.

  • - CFO, Sr. VP-Fin.

  • We provide - - Eric, we provide detail in our SEC filings as to how we break up research and development and product development and in research and in end licensing.

  • We don't specifically indicate the total costs associated with manufacturing.

  • But I think if you look at the pre-manufacturing, or the manufacturing start-up costs and a pretty good portion of that, of the total employees base devoted to manufacturing, I think you can derive some - - a pretty good estimation of that total cost.

  • - Analyst

  • Okay.

  • Thanks.

  • - Pres, CEO, Director

  • I know we didn't address all your questions, Eric.

  • Did we address the last one?

  • - Analyst

  • I'm not sure if you're saying that I should just go dig it out myself, or if - - because it's there.

  • Or, you know, it would just be helpful if you can kind of give us a sense.

  • I could dig it out myself, if you want me to.

  • But I was just asking the question just to get to the more directly.

  • - CFO, Sr. VP-Fin.

  • Let me give that a little bit of thought, Eric and make sure I cover it before the call is complete.

  • - Analyst

  • All right.

  • Great.

  • Operator

  • And your next question comes from Kim Lee with Jefferies & Company.

  • Please proceed.

  • - Analyst

  • Thanks for taking my call.

  • - Pres, CEO, Director

  • Hi, Kim.

  • - Analyst

  • This question is for Gisela.

  • Could you remind of us the trial design for the Phase I multidose ABX PTH trial?

  • - Chief Medical Officer

  • Yes, we are planning a multidose study with ABX PTH.

  • We haven't as yet revealed or discussed the design of such a study.

  • And I'm not in a position to do so today.

  • But obviously the study would be - - is based on observations, encouraging observations made in the single dose Phase I study where we've seen a dose dependent reduction in pre-parathyroid hormone levels in response to administration of ABX PTH.

  • And we've also seen a reduction of calcium and the calcium phosphorus product into the range of - - provided by the [K-Delco] guidelines, after a single-dose administration of ABX PTH.

  • So we're building on the experience gained in the single-dose Phase I study to design the multiple dose study.

  • And we'll be happy to discuss in that more detail in a future call.

  • - Analyst

  • Okay.

  • Do you know as of right now what doses you're looking at?

  • - Chief Medical Officer

  • That is a little premature to say at this point.

  • - Analyst

  • Okay.

  • Thanks.

  • - Pres, CEO, Director

  • Thanks, Kim.

  • Operator

  • Your next question comes from Bonnie Feldman of CCL Partners.

  • Please proceed.

  • - Analyst

  • Thanks for taking my question.

  • It was about the data that's going to be presented in the coming in the upcoming ASMO.

  • While I have you one the phone, do you have any other plans to present data at other meetings that you would like to let us know about now?

  • - Chief Medical Officer

  • Well, we haven't decided on the medical meetings at which other data will be presented as we stated earlier on.

  • But we anticipate data and results of the non small-cell lung cancer study to be available in 2005.

  • Potentially as well on the renal cell cancer Part 2 study.

  • And possibly on the second part of the study in colorectal cancer first-line therapy that I referred to.

  • We are also hoping that on the basis of the Phase I single-dose study then the multiple dose study can roll out for ABX PTH in 2005.

  • And data will become available towards the end of 2005 beginning 2006.

  • In the immediate future, we are - - besides the ASMO presentation also planning on presenting the information on the single-dose study with ABX PTH at the upcoming ASN meeting as well.

  • - Analyst

  • Thank you very much.

  • - Pres, CEO, Director

  • Thank you, Bonnie.

  • Operator

  • And your next question comes from Gill Aram of Infineon.

  • Please proceed.

  • - Analyst

  • I was wondering whether - - I don't know if you can comment about that but with respect to the pivotal trial of panitumumab is it fair to assume that the end points in the European trial are different than the U.S. trial?

  • - Pres, CEO, Director

  • Let me ask Gisela to comment on that, Gill.

  • - Chief Medical Officer

  • So the end points - - we haven't really discussed the end points and specifics of the trial design of either study.

  • But I think what we have stated is that the European study is a randomized controlled study.

  • And those studies lend themselves better than single arm studies to assessing end points such as time to progression and survival time.

  • - Analyst

  • And I was wondering whether we're going to see any time soon a trial in the chemo refractory population in the second line setting for colorectal cancer with panitumumab?

  • - Chief Medical Officer

  • Well, the trials that are currently ongoing are assessing the chemotherapy refractory, if you will, patient population, which is the patient population with the unmet medical need, and those are patient who have failed three prior chemotherapy regimens, including fluorouracil, irinotecan and oxaliplatin.

  • So this is the patient population in the pivotal program.

  • - Analyst

  • Right.

  • I'm sorry, I apologize.

  • I mean in combination with chemo.

  • Panitumumab in combination with chemo and the refractory population.

  • - Chief Medical Officer

  • I see.

  • There is a broad effort ongoing to design a broad development plan for panitumumab.

  • And Amgen is obviously leading this effort, leading the development of the compound.

  • And this effort includes indications such as first and second line colorectal cancer but there are also other indications as well.

  • - Analyst

  • Okay.

  • I know Mr. Ringo, if I can try and get some of your insights from your experience.

  • Maybe if you can give us a sense as to your view of the competitive nature of the market.

  • And how you see panitumumab being positioned.

  • And if you feel that Abgenix should take an active role in the marketing of it down the line, I guess?

  • - Pres, CEO, Director

  • Well, let me first, Gill, it's obviously early in Amgen's preparation for the commercialization strategy.

  • I've had a chance to sit through one session.

  • Clearly looking at that time way in which they will conduct a variety of clinical trials that will help move the molecule beyond monotherapy for stage 3 or 4 colorectal cancer.

  • The other piece of that is the opportunity to look at targeted therapies, Gill, and where does panitumumab fit in that mix.

  • And then we have not had any discussions in terms of their commercial strategy as it relates to the overall size, structure of the sales organization.

  • We do have an opportunity, as you know to co promote turned agreement, and that's part of the overall look that we're taking in terms of our strategic direction as a Company, to really try and evaluate when that makes sense for us, whether it's the best thing to do for the molecule.

  • And we'll make those decisions as we get closer to looking at the launch of the product.

  • - Analyst

  • Thank you very much.

  • Operator

  • [Caller Instructions.]

  • - Pres, CEO, Director

  • I'd like, Mia, if we could, from our end, I think Eric had had a question that we didn't completely answer in terms of manufacturing.

  • We'd like to go back and try and address that, if we could.

  • And I'm assuming that Eric is still on the call.

  • Ward, you want to go ahead?

  • - CFO, Sr. VP-Fin.

  • Sure.

  • Eric, are you still there?

  • Operator

  • Eric's line is closed.

  • I can open it if you'd like.

  • - Pres, CEO, Director

  • Okay.

  • Please.

  • - CFO, Sr. VP-Fin.

  • Let me just give an overview on the manufacturing facility.

  • Again, let me preface this by saying just for competitive reasons, obviously, we don't provide all the analysis here.

  • But certainly a significant portion of our property and equipment on the balance sheet is tied up in the plant facility.

  • And if you look at the number of employees and the manufacturing start-up costs, et cetera, on the income statement, I think it's fair to say that our plant related expenses are in the range of 25% to 35% of the R&D and start-up manufacturing costs.

  • At any particular quarter.

  • In terms of the market value for the plant, as Bill indicated, this is very early and so we're, you know, there obviously comparables out there, but that's very early in our process at this point.

  • - Analyst

  • Thanks.

  • That's very helpful.

  • Operator

  • You have no further questions at this time.

  • - Pres, CEO, Director

  • Okay.

  • Let's - - why don't I go ahead and wrap up with that.

  • I'd like to come back to summarize, if I could.

  • In terms of our third quarter results, Ward went through those in detail.

  • Keep in mind we're working towards the accomplishment of our 2004 goals.

  • The top of that list is making sure we do everything we need to do in our partnership.

  • Preparing for the submission of panitumumab and our responsibility from a CM&C perspective, that we continue to provide our insight to our partners as it relates to the commercial strategy and also the ongoing clinical and regulatory strategy.

  • We're working on our corporate strategic look and would expect to take the next 3 to 4 months to complete that.

  • At the same time we want to take our product portfolio, particularly when we look at PTH and make sure we get it into a multidose Phase I trial.

  • Certainly before the end of the first quarter of '05, if not sooner.

  • And at the same time, look at all of the antibodies that are in a preclinical position to provide the right commercial insight into that.

  • And make sure that we move those antibodies with the greatest potential.

  • Whether it relates to one of our collaborations or ones that we own on our own, into an IND and into the clinic.

  • And at the same time, we're working very hard as a senior management group.

  • And you've got that group sitting at the table today trying to make sure we look at every way to improve our efficiencies as a Company.

  • And make sure that we are diligently looking at our operating expenses going forward.

  • And then lastly, we are looking at alternatives to continue to raise money for the Company.

  • And we'll be making some decisions very shortly on those.

  • Thank you very much for your attention today.

  • We appreciate your interest in Abgenix.

  • Thank you, Mia.