美國安進 (AMGN) 2004 Q1 法說會逐字稿

Good afternoon and welcome ladies and gentlemen to that Abgenix first quarter 2004 financial report and update conference call. (OPERATOR INSTRUCTIONS) I would now like to turn the call over to Dr. Ray Withy, President and CEO and Abgenix.

Sir, please go ahead.

Thank you.

Good afternoon everyone and thank you for joining us for our first quarter 2004 review call.

I am Ray Withy, President and CEO of Abgenix.

Also on this call are Gisela Schwab, our Chief Medical Officer, and Ami Knoefler, our Director of Corporate Communications and Investor Relations.

Before we begin I must remind you that during the course of this 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, which 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.

The Company undertakes no obligation to update any projections or forward-looking statements looking statements in the future.

Now, today we will review financial results for the first quarter of 2004, recent pipeline and corporate developments and key milestones for the rest of 2004.

In 2003 we made significant strides in our transformation into a product development company with seven XenoMouse derived product candidates currently in clinical trials and large numbers of pre-clinical candidates which may be advanced into the clinic by Abgenix or its partners.

Progress has continued into 2004, as reflected in several key developments during the first quarter.

Most notably our most advanced product candidate, panitumumab, formally known as ABX-EGF has made further progress towards commercialization with the launch by our partner Amgen of two pivotal trials in third line colorectal cancer patients.

Abgenix also launched the first clinical trial for ABX-PTH, our proprietary antibody for potential treatment of secondary hyperparathyroidism, and enrollment for this trial is currently underway.

Abgenix retains full commercialization rights for ABX-PTH and we do not intend to partner this product during this product candidates early stage development, if ever.

In our technology licensing collaborations we also saw important progress this quarter.

We received a milestone from Pfizer following the filing of their third IND resulting from our ongoing collaboration and we were very pleased to see positive interim data presented from Amgen's development program for its fully human antibody that was generated by our technology, a potential treatment for osteoporosis.

During the quarter seven abstracts were presented at the American Association for Cancer Research meeting regarding Abgenix derived antibodies, reflecting progress made both by Abgenix and its partners in our expanding oncology portfolio.

The abstracts included two abstracts from Abgenix regarding our EGFRvIII antibody program which continues to be evaluated in pre-clinical studies as a potential oncology treatment.

Abgenix and Curagen jointly published a report on in vitro studies with CR012, an antibody candidate for ovarian cancer.

One late breaker abstract was presented by Amgen and Abgenix scientists showing tumor penetration of panitumumab in the xenograft model.

Finally, several abstracts were also presented by Pfizer on their two most advanced fully human antibodies programs from our ongoing technology licensing collaborations.

Both programs are XenoMouse derived antibodies to oncology targets.

The targets are CTLA4 and IGF-1 Receptor.

Finally, during the first quarter we sought an S-3 universal shelf registration statement that when it is declared effective provides Abgenix with future financing and flexibility.

Now let me go into more detail regarding progress made on our growing antibody product portfolio.

Our co-development partner Amgen initiated a pivotal trial in United States in the first quarter evaluating panitumumab as of third line monotherapy in colorectal cancer patients.

A pivotal study has also been launched outside of the United States to support the product candidate's global development.

We believe that the US trial, which has received a special protocol assessment from the FDA, will form the basis of a regulatory submission as a monotherapy in advanced colorectal cancer patients who have been treated with prior chemotherapy.

Both trials are underway.

As we proceed with panitumumab scale-up for a potential BLA filing and commercial launch, Abgenix's primary role is to lead the clinical and commercial scale production.

Amgen is providing assistance with these activities.

We also continue to add resources in manufacturing and quality to support this initiative.

Turning to the overall clinical program for panitumumab, there are multiple Phase II studies ongoing to evaluate panitumumab as we continue to explore the potential of this promising class both in monotherapy and/or combination therapy in several tumor types.

Importantly, in the second quarter we will see data from two of the ongoing Phase II studies presented at the ASCO meeting in New Orleans, including a presentation of the full 150 patient data sets from our monotherapy studies in third line colorectal cancer patients.

You will recall that it interim results of this trial formed the basis for the pivotal trial launched by Amgen earlier this year.

Also at ASCO, a second poster will describe interim Phase II safety results of the first part of a study with panitumumab in combination with chemotherapy for the potential frontline treatment of patients with non-small cell lung cancer.

The randomized part two of this study has only recently completed enrollment.

For both studies we intend to respect ASCO's embargo and will not be commenting on the specific data (inaudible).

As mentioned, there are now seven XenoMouse derived product candidates in clinical trials compared with four at this time last year.

In addition to our co-development of panitumumab, we now have two products in the clinic that are being solely developed by Abgenix, ABX-MA1, and as mentioned earlier ABX-PTH.

ABX-MA1 is currently being studied in a Phase I single dose, dose rising study in malignant melanoma.

Astra Zeneca have the first right to evaluate this product opportunity on terms yet to be negotiated.

We expect to have data on this program late this year.

In addition to our proprietary products, four products from our technology licensing program are being developed by our licensees.

We continue to be encouraged by the progress made by Pfizer and Amgen, which highlight the important role the technology licensing program play as a component to our overall product portfolio.

During the quarter Amgen presented clinical data on an antibody they are developing that was generated using Abgenix's technology.

The product, AMG-162, a fully human antibody (indiscernible), has shown positive interim results as a potential product to treat osteoporosis.

We were particularly intrigued by the potential dosing regime of this product, which we believe points to the promise of antibodies and their potential advantages with therapeutics.

Late stage trials could be launched by Amgen later this year.

As I have indicated to you in the past several years, both the technology licensing program and now our AZ collaboration contribute to moving Abgenix toward a positive cash flow business.

Future milestones and royalties from our licensees support our future growth as a product company, and we look forward to additional INDs and progress with those antibodies currently in clinic.

In the interim AZ revenues could kick in as early as next year, dependent upon how quickly we can jointly advanced targets through the collaboration.

We are pleased with the efforts so far and look forward to providing updates later this year on the target selection phase of this collaboration.

On the financial front we ended the quarter with $307 million in cash, cash equivalents and marketable securities.

Net cash used in operating activities was $38.2 million, and importantly is expected to decrease later in 2004 as the $60 million credit facility from Amgen becomes available and we draw on it to fund Abgenix's share of the panitumumab research and development costs.

With these developments and the progress made in advancing our portfolio, we believe we're well along in transforming Abgenix into a product development company with a strategy designed to mitigate risk, while building a pipeline of promising product candidates that address a wide range of diseases in significant markets.

As the antibody space has come of age, we believe we're uniquely positioned to fully deliver on the promise of antibodies as the ultimate targeted therapy while we maintain our industry-leading position as the partner of choice in the field.

Thank you for your ongoing support, and we look forward to providing you with further updates as things continue to progress at this very exciting time.

I will now open up the call to your questions.

(OPERATOR INSTRUCTIONS) Meg Malloy, Goldman Sachs.

I know you can't comment on the details of your pivotal studies too much, but I'm wondering, Ray or maybe Gisela, if you could walk us through your thinking in terms of strategy for obtaining regulatory approval, particularly in light of the results that we've seen with Erbitux and now Tarceva and Avastin.

I think we're feeling in pretty good shape because the pivotal trial in third line colorectal is under a special protocol assessment from the FDA which could lead itself to accelerated approval.

I'd like to hand over to Gisela to add some color to that and perhaps a frame on our strategy.

The pivotal studies, as Ray mentioned, are being conducted in late stage colorectal cancer in patients who have failed prior chemotherapy.

And those studies are based on observations, as you are aware, that were published at the ASCO meeting last year indicating a robust activity in this setting with a 10 percent response rate in this patient population.

Now, this patient population obviously has an unmet medical need, and therefore could be -- or can be -- a patient population that could justify an accelerated approval pathway for registration, and so the pivotal study obviously is designed to potentially support that.

And obviously that will be data dependent if we can embark upon such a pathway.

But that is taken into consideration in the design.

If I could follow up on that, if you were to get a 10 percent response rate again do you think that would be sufficient in this patient population?

That would be part A. Part B, how do you complete with something like Avastin which has shown a mortality benefit?

Gisela, it seems like that is yours again.

I think a 10 percent response rate in a patient population in oncology, a patient population that has failed prior therapies with chemotherapeutic agents and has no standard of care available to them, is a robust activity signal, and so I think that is a very encouraging result.

Regarding competition, of course Avastin is targeting a different pathway in that it is an anti-angiogenic agent that has been studied and very encouraging data has been presented and lead to approval in the first line setting of colorectal cancer.

Now, our strategy is targeting late stage colorectal cancer patients in the current studies, third line therapy of colorectal cancer, so there is no direct competition.

Thanks.

(OPERATOR INSTRUCTIONS) David Witzke, SunTrust.

Thank you for taking my question.

This is for either Gisela or Ray.

My question is regarding the 150 patient Phase II monotherapy we will see at ASCO.

As I recall from the interim look at last ASCO, 4 or 5 of 44 patients had failed both oxali, as well as irinotecan, and since then you have enrolled another 50 that have failed both.

So the question -- out of the total 150 how many have failed both chemos?

Certainly a question for Gisela.

Just referring back to the data presented at the last ASCO meeting, 4 out of 44 patients had shown a partial response and at the time ophthalmic platin (ph) was not in the market as yet in United States, so none of these patients had received previous ophthalmic platin -- none of the responders -- and 10 or 11 percent of the total population had received ophthalmic platin of the 44.

Now obviously since ophthalmic platin has been approved in the United States, and a certain proportion of patients enrolled in the study will have seen ophthalmic platin exposure.

However, we cannot comment on the proportion at this time as we are intending to respect the ASCO embargo.

But is it accurate you did enrolled an additional 50 that had failed both oxali and irinotecan?

The study results that will be presented at ASCO are full data on the 150 patients, so having had data on 44 patients last year; an additional 106 patients have been accrued during that period.

I think with regards to add extra 50 patients, let me clarify that part.

The original study had been designed for 100 patients and when oxaliplatin was approved we decided that we would expand that trial from 100 to 150 with the goal of certainly increasing the proportion of oxaliplatin failures that would be in this overall patient population.

And so obviously one can potentially surmises the proportion of oxaliplatin failures will be increased, but we can't give you exact numbers again because of the ASCO embargo.

I understood, but that proportion should be more representative of what the Phase III looks like, so we look forward to seeing that data as a subset, I guess.

Just one final question, if I can.

The Phase II, the entry criteria -- two plus or three plus over expression of EGFR in I think 10 percent of tumor cells -- is this being incorporated as an entry criteria in the Phase III trial?

Gisela, I don't know if we're commenting on entry criteria, but please go ahead.

Generally, in the program for panitumumab we have pre-screened patients who were using (indiscernible) chemistry for EGFR expression, and that is going forward the case as well.

Final, if I, may.

On the manufacturing front are we still looking at a potential deal later this year on the contract side?

Certainly that is a corporate goal and we are working towards finding a partner or partners that could avail themselves of current excess capacity that we would have.

We are being rather cautious, however, in the timing of bringing on such a product.

It's very important for us to ensure that we have done everything that we need to do to advance panitumumab.

Obviously that has our first priority.

But yes, later on in the year there's going to be the potential for excess capacity that could be utilized.

And it's going to be a while before the organic growth of our portfolio will fully utilize the capacity in our plan, so there's an opportunity there to bring in potentially some revenue that could help defray the operating costs of the plan.

Thank you.

Anna Jolie Colaquar (ph), Argus Partners.

Could you just remind us of the clinical trial design of your Phase II non-small cell lung cancer -- the design of the Part 1 and the design of the Part 2?

And then can you just update us on your renal cell cancer?

And I believe, but I might be wrong, that you had another colorectal trial going on.

I think all of that is correct.

Gisela, why don't you summarize the current Phase II program for us, please?

We have a broad Phase II program ongoing, and as you state one study is conducted in non-small cell lung cancer where the safety and activity of panitumumab is evaluated in combination with chemotherapy that is carboplatin and paclitaxel.

So the first part of that study is to analyze the safety of the combination of panitumumab and chemotherapy.

The second part of the study is a randomized part where patients have been randomized to either receive chemotherapy alone or chemotherapy plus panitumumab, and accrual to that second part has recently been complete.

Regarding the renal cell cancer indication, we had published data on panitumumab single agent therapy at ASCO 2002 in patients who had received prior therapy with biological agents for renal cell cancer.

And in these results we have seen a number of responses that led us to further expand that study into a Part 2 that analyzes the effect of single agent panitumumab in patients who are either naive to prior systemic therapy or have received just one prior biotherapy and that study is currently ongoing.

And then lastly, in the colorectal cancer first line setting the study is designed to evaluate safety of panitumumab with first line chemotherapy for colorectal cancer consisting of 5-FU, leucovorin (ph) and irinotecan.

And also that study is currently ongoing.

When will we have the results for the Part 2 of the renal trial?

These studies are currently ongoing, either still accruing or treatment is ongoing.

So we cannot project exact timing at this point in time, but we will as soon as we have data, obviously published that data at the relevant meeting.

And what about -- maybe that was an answer to all three, but what about for non-small cell lung cancer and the colorectal trial?

Same thing?

Yes, that applies to those as well.

Thanks very much.

Brian Rye, Janney Montgomery.

I just wanted to ask a quick housekeeping question on the financials.

And I know you had given a little bit of guidance at the end of 2003 providing cash burn and capital expenditures for 2004;

I just wanted to make sure that those expectations were still intact.

Yes they are.

Let me reiterate what we said at our last conference call.

We are giving guidance this year on the net cash used in operating activities, and we project that that will come in at somewhere between 110 and $125 million.

The net cash used in operating activities for this first quarter was $38.2 million.

I'd like to caution you that it's very difficult to assume, therefore, that you can take that number and multiply by four and you'll get the answer.

There's sufficient variability both in revenue expectations and expenses from quarter-to-quarter.

But we're still very confident that our guidance remains intact.

With regards to capital spending, you can see that we spent a very little amount on capital this year.

Our guidance is up to $25 million.

Again, that is intact.

And I think we're feeling pretty much on track.

Sounds great.

Thanks.

(OPERATOR INSTRUCTIONS) Paul Jakes (ph), Bloomberg Capital.

It's Paul DeSitenlar (ph) of Bloomberg.

I just want to ask you a quick question on the Phase II that you'll be presenting at ASCO.

What exactly is the end point?

Obviously you've got a lot more patients now than you had at the interim look, so you might be able to see things you didn't see with a much smaller number of patients.

And I have another question after that.

Gisela, could you comment on that, please?

The primary end point for this study is to evaluate the activity of panitumumab in this setting as measured by the response rate observed in this patient population.

In addition, obviously we will be analyzing end points that are traditionally analyzed in such oncology studies, such as time to tumor progression and also the safety, of course, of panitumumab in this setting.

And in the Phase III you are using EGFR as a stratifier?

In the Phase III we haven't really commented on the design of the Phase III to that level of detail.

And you might have already mentioned this, and I apologize if you have.

What are we expecting in terms of the timing for the completion of the Phase III?

The pivotal studies are currently ongoing, and Amgen has launched those studies earlier this year.

And we cannot really comment at this point in time on accrual, but suffice it to say that Amgen had expressed confidence at their R&D presentations a little while ago with respect to that accrual of patients.

So obviously as the completion will depend upon accrual of patients.

Thank you very much.

Ladies and gentlemen, this concludes the question and answer portion of today's call.

I will now turn the presentation back to Dr. Dr. Withy for his closing remarks.

Thank you very much.

Thank you all for attending this conference call.

You can see progress is being made.

We remain very excited about panitumumab.

And we are also, of course, working very hard to expand the portfolio.

We're working at moving pre-clinical candidates, both prioritizing them and moving them along, for future clinical developments.

So hopefully more updates on that in the months and years ahead.

Once again, thank you very much for attending this call.

Ladies and gentlemen, this concludes your presentation for today and you may now disconnect.

Have a great day.