美國安進 (AMGN) 2003 Q1 法說會逐字稿

Thank you for holding.

Welcome to Tularik's Q1 2003 financial results conference call.

At this time all participants are in a listen-only mode.

There will be a question and answer session to follow.

Please be advised that this call is being taped.

At this time, I would like to introduce your host for today's call, Traci McCarty, Investor Relations Actuary.

Please go ahead.

Thank you Operator.

Good afternoon and thank you for joining us to discuss our 2003 Q1 results.

Presenting highlights from the quarter today are Dave Goeddel, our Chief Executive Officer and Founder and Bill Rieflin, our Executive Vice President, Administration and interim Chief Financial Officer.

Andrew Perlman our Executive Vice President is also here to answer any questions that you may have during the q and a portion of the call.

Before we get started, let me remind you that some of the statements made today will be forward-looking and that our actual results may differ materially from those suggested.

Please refer to our most recent SEC filings for information concerning factors that could cause these differences.

Information in this conference call related to projections or other forward-looking statements may be relied upon subject to the previous safe harbor statement as of the date of this call, and we undertake no duty to update this information.

I will now turn the call over to our CEO.

Please go ahead Dave.

Thanks Traci and thank you all for joining us today.

During this first quarter, we made continued solid progress in the Clinic and with our Pre-Clinical Research programs.

In March we were pleased to announce the launch of our pivotal trial with T67 for the treatment of Hepathoid (ph) carcinoma or HCC.

We are currently enrolling patients in our US sites and plan to begin enrolling patients around the world, including Russia, Hong Kong, Thailand, Singapore, Taiwan, the UK, Brazil, South Africa, later this year.

This drug holds real hope with patients with HCC, a devastating disease for which there is no approved systemic therapy.

We are enrolling our registration trials as aggressively as possible and will provide enrolment update at the end of the year.

Also in the oncology therapeutic area, T607 continues to move forward in phase 2 studies looking at four tumor types, Apatocellular carcinoma, ovarian cancer, gastric cancer and esophageal cancer.

During the quarter we hold that the non-Hodgkinson lymphoma study for a variety of reasons including cost containment, low patient enrolment and a competitive landscape that limited our market opportunity.

By the end of this year we will provide an update on these trials and our plans for moving forward with these indications.

The immune disorders area, we initiated the multiple ascending dose Phase 1 study with T487, our novel drug candidates for the treatment of inflammatory diseases.

We are on track to complete that study as planned in the first half of the year and to begin Phase 2 studies in psoriasis and rheumatoid arthritis later in 2003.

To date we are very pleased with the PK data and the safety profile that we have seen with T487.

In the metabolic disease area, T131 is being developed for type 2 diabetes.

T131 is a novel and potent insulin sensitizer that has a superior profile in pre-clinical studies when compared to existing agents such as Actos and Abandia.

T131 is currently completing the single ascending dose phase 1 study.

We are pleased with the PK data and the safety profile seen today with this compound and expect to begin the multiple ascending phase 1 study in the second quarter and to initiate phase 2 studies by the end of the year.

Our research discovery efforts continue to be productive.

To give you one example, in our alka (ph)gene discovery program we published a discovery of a new gene that had expressed an abnormally high level in nearly 50% of breast cancer specimens we have examined.

The gene, KC and K9 encodes an attractive target for the development of novel cancer therapies against the most common forms of breast cancer.

Scott Powers, who heads our Genomics Division and other scientists, use Tularik’s proprietary RDA and other techniques to discover KC and K9.

This gene represents a good example of the potential implicit in many of the roughly 30 amplified archigenes that we have discovered in this program.

In addition to the progress of our research and clinical programs, we were also pleased to see Regeneron team up with Novartis to move their R01 trap drug forward.

Tularik provides with Regeneron a non-exclusive license for use in connection with their R01 trap program for which we are entitled to royalties based on net sales in this drug if and when it is approved for sale.

Before turning the call over to Bill, I would like to address a question raised by several investors during the quarter and that is the status of Tularik's shares owned by ZKB Pharma Vision.

At the request of Pharma Vision, we worked with the SEC to register these shares and they became freely tradable earlier this month.

We have received calls from a number of investors interested in these shares.

We have forwarded them the appropriate contact at ZKB.

I will now turn the call over to Bill Rieflin, our interim CFO, to review the quarterly financial results.

Thanks Dave.

In Q1 of 2003, total revenues were $6.7m compared to 2002 Q1 revenues of $6.2m.

Revenues in Q1 of 2003 were comprised of $5.1m from collaborate research and development and $1.6m from technology license fees.

Our 2003 collaborative research revenues were primarily derived from research payments from Japan Tobacco in the metabolic diseases area, [indecipherable] GPCRs and Medarex for cancer.

Decline in collaborative research revenues for Q1 of 2003 as compared with Q1 of 2002, was a result of the exploration of our collaboration with Roche in July of 2002 and was partially offset by revenues from the Sankio (ph) collaboration.

Revenues from technology licenses for Q1 of 2003 relate to our receipt of preferred stock in a private company in exchange for a license to certain technology and the assignment of certain patents.

Total R&D expenses for Q1 2003 increased to $28.3m from $25.2m for the same period in 2002 due to increased development costs related to our clinical programs, increased researched spending at Cumbre, our majority-owned subsidiary and increased research headcount.

General and administration expenses for Q1 of 2003 increased to $3m from $2.7m for the same period last year due to higher legal and accounting expenses.

Interest income in [indecipherable]decreased to $800,000 for Q1 of 2003 from $1.6m for Q1 last year.

This decrease was due to lower cash and investment balances as well as lower yields on our investment portfolio.

Our net loss was $24.2m in Q1 of 2003 or $0.44 per share, compared to a net loss of approximately $20.6m or $0.41 per share for Q1 of 2002.

We ended the quarter with approximately $156.3m cash in marketable securities and this includes $17.7m in cash at Cumbre.

This does not include $4.3m of restricted investments and $3.6m of investments in private companies.

We will now open the call to your questions.

Thank you.

At this time we will take any questions you may have.

If you have a question, please press the '' followed by the '1' on your touchtone phone.

You will be put into a queue.

If you would like to cancel your question, please press the '' followed by the '2'.

Again, if you have a question, please press '1'.

To cancel, please press '2'.

If you are on a speaker phone, please pick up your handset to ask the question.

The first question comes from the line of Han Li).

Please go ahead with your question.

Yes, this Han Li with David Witzke.

We have two quick questions.

The first one is, are you on track for one or two more INDs for this year, and in what therapeutic areas?

And the second one we have, is can you give us an update on your CFO?

Thank you.

Hi, this is Dave.

The first question, the INDs.

Yes, it is our stated and continued goal to file one to two new INDs or equivalents each year.

We have obviously filed two last year and it is still our expectation for 2003.

As far as therapeutic areas, we have not disclosed that, but we have six candidates that we are actively pursuing and they fall across each of our three therapeutic areas, metabolic disease, immune and cancer.

So the ones that will actually get to that stage this year have not been disclosed.

Okay.

And I think the next question was the progress towards a CFO?

Yes.

So we have been actively interviewing and hope to be able to be in a position to make an offer reasonably soon.

Please stand by one moment ladies and gentlemen.

Just as a reminder, if you do have a question, please press '1' on your touchtone phone.

Our next question comes from the line of Lucy Lu.

Please go ahead with your question.

Hi, this is Lucy Lu, calling from [indecipherable].

Just a quick question.

One of the reasons you decided for halting T607 in non-Hodgkinson lymphoma was limited market opportunity.

I was wondering if you could talk a little bit about that.

Why is that really a reason for you to halt of the trial in this indication?

Thanks.

Hello.

This is Andrew Perlman.

The limited market opportunity was one of a number of reasons that we decided to halt the T607 non-Hodgkinson lymphoma arm.

You will recall however that there are still four studies ongoing with T607 and we are hoping to see good results in each of those studies obviously.

But addressing your question about the reason for halting this specific arm and the market opportunity.

On the first hand we felt that there was a great deal of competition for these patients, in part because the existing agents do seem to work well in those categories that non-Hodgkinson lymphoma that would be most likely to respond to therapy.

As a result of that, our enrolment rate was extremely slow.

That in combination with our attempts to be mindful of our expenditures, caused us to eliminate this so we could put these resources on to other more promising areas of clinical research.

Can I just ask a follow up question.

So in non-Hodgkinson lymphoma were you trying to use it in first line or second line, where you use salvage therapy.

Well, part and parcel of the landscape in the treatment of non-Hodgkins lymphoma is the fact that it would be almost impossible to recruit first line patients for the most common types of non-Hodgkins lymphoma in the context of this phase 2 study.

So the patients we were looking at for the most part, had received other forms of therapy.

Okay.

Thank you.

Our next question comes from the line of Ansley Callhapter (ph).

Please go ahead with your question.

Hi.

I am just wondering, have you given guidance for your burn rate for 2003 and also can you talk about some of the products that you might be looking for partners for?

Thanks.

Well, I will take the first part of that question.

We have previously given guidance for the burn rate for 2003 will be $100m.

This is Dave.

On the second part the question had to do with partnering for 2003, is that correct?

Yes.

We have a number of discussions underway, some at the pre-term sheet, some at the term sheet stage with good companies across a number of our programs, so it is a very active year in the business development side and we put an increased emphasis on partnering this year with bringing in Jack Anthony during the last year and we are in a large number of discussions at the moment, across all of our programs.

Okay.

Is it more geographical partnering, or invitation?

I would say there is both kinds and they range also from research stage programs to individual compound-type discussions.

Okay.

Thank you.

Thank you.

If there are any additional questions, please press the '' followed by the '1' at this time.

Dr Goeddel, there are no further questions at this time.

Please continue.

Thanks very much for joining us today and we will speak with you again next quarter.

Ladies and gentlemen a replay of today's conference will be available from 3pm Central on April 24 2003 until midnight Central April 26 2003.

Ladies and gentlemen, that does conclude our conference for today.

Thank you for participating.