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ARRY: Q2 FY09 Transcript, from Seekingalpha.com w/slight edits.

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ThomasS   Wednesday, 02/04/09 06:20:39 AM
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ARRY: Q2 FY09 Transcript, from Seekingalpha.com w/slight edits.
{IMO, there was little new info that hasn't already been mentioned here.}

Robert E. Conway

Over the past couple of months, we have concentrated our resources on advancing eight promising clinical programs through proof of concept. We anticipate having either proof of concept or Phase I clinical results on all eight of these programs in calendar 2009.

An important element of Array's strategy involves partnering our clinical program at proof of concept for late stage development and worldwide distribution while retaining some or all U.S. rights. In addition to our eight 100% owned Array drugs in clinical development, we disclosed three advanced discovery programs at the JPMorgan Conference in early January and are in partnering discussions around all three.

Partnering our development and discovery programs will be a major source of funding in 2009. We anticipate raising $80 million this year through partnering new programs and milestones from existing programs.

Earlier this month, we disclosed a series of actions to reduce net cash used in operating activities to approximately $20 million per quarter during 2009. This is before any new milestone or partner payments. We have sized Array's development capability for proof of concept studies on a finite number of programs and have scale back our discovery and early research activities to our three most advanced internal programs. With eight drugs in development before we advance any new programs from discovery into clinical development, we need to partner one or more of the existing drugs.

We made significant progress this quarter advancing our clinical pipeline. Kevin Koch, our Chief Scientific Officer will report in more detail on three specific programs in just a minute. Those are ARRY-403, our glucokinase activator, ARRY-543, our ErbB-2/EGFR inhibitor and ARRY-614, our p38/Tie-2 inhibitor.

Let me now report on the five other development programs.

ARRY-162, our MEK inhibitor for inflammatory disease continued a 200-patient, 12-week Phase 2 trial with 162 added to methotrexate in patients with rheumatoid arthritis. Over 100 patients had been enrolled by the end of last year and we anticipate completing enrollment this quarter. We plan to provide top line results on this trial in late summer 2009.

ARRY-797, a p38 inhibitor, initiated a worldwide 170-patient, 12-week Phase 2 clinical trial in patients with ankylosing spondylitis in December 2008. We also completed a dose escalation trial with ARRY-797 to test its tolerability up to 1200 milligrams daily in a sub-chronic setting for seven days. We are on track with recruitment of a 28-day Phase 1b trial of 797 in patients with stable rheumatoid arthritis taking methotrexate. We announced the achievement of both the primary and secondary endpoints from a 250-patient Phase 2 acute inflammatory dental pain study, evaluating the drug's analgesic effect at the 2008 AACR Meeting in San Francisco.

Dosing was initiated with ARRY-300, a targeted small molecule MEK inhibitor in a Phase 1 clinical trial. The Phase 1 trial is a single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers. We are in the process of initiating sites in a Phase 1b/2 trial of ARRY-520 a novel kinesin spindle protein inhibitor or KSP inhibitor in patients with multiple myeloma. The Phase 1 trial of ARRY-520 in patients with solid tumors and a Phase 1/b2 trial of 520 in patients with AML are both continuing.

Recruitment in a Phase 1 safety trial of ARRY-380, a selective, oral ErbB-2 inhibitor remains on track. This trial is expected to complete enrollment later this summer.

At the JPMorgan Healthcare Conference, Array disclosed three advanced discovery candidates: Chk-1 inhibitor which is a first-in-class selective oral inhibitor for the treatment of cancer; a Trk inhibitor, a first-in-class, selective, oral inhibitor for the treatment of pain and PDGFR inhibitor a best-in-class, selective, oral inhibitor for the treatment of fibrosis.

On the partnering front we received a million dollar milestone payment from VentiRx for VTX-2337, a toll-like receptor agonist, entering Phase 1 clinical development for the treatment of cancer. Array licensed its TLR program to Venti in VentiRx in 2007 and retains the option to acquire a 50% ownership position in all clinical oncology products developed under this agreement.

We pass it over to our Chief Financial Officer, Mike Carruthers to drill down on the financials. Mike?

R. Michael Carruthers

Thank you, Bob. Array's revenue for the second quarter of 7.7 million is above the consensus estimate due to the milestone payments we received on the toll-like receptor from our partner VentiRx who is progressing in a Phase 1 dose escalation trial in cancer patients.

Our loss per share for the quarter of $0.79 includes a $0.22 charge to adjust the book value of our auction rate securities to estimated fair market value. These auction rate securities now have a book value of 17 million and are included on our balance sheet in long-term marketable securities.

Our R&D spending for the quarter of 24 million was less than both the last two prior sequential quarters. This is the result of fine tuning the scope and number of the trials we are running. Recall, we reduced our employment level in early January by 2%. This reduction is not yet reflected in the spending level of the numbers we are now reporting.

As of December 31st, Array's cash equivalents and marketable securities totaled $100 million. We are comfortable with this cash position given we only used 25 million in the quarter just ended after removing the $4 million all employee bonus we paid in early October. Also recall that we used 23 million of cash during the prior sequential quarter. With our recent cost reductions, we expect to use approximately 20 million per quarter going forward.

We have not updated guidance since August last year. With the changes we've made to reduce spending, the due guidance for the fiscal year ending in June is as follows. These numbers are before inclusion of any new partnerships that could occur.

Revenue is projected to be $26 million and all of the following spending numbers include compensation expense from stock options: Cost of revenue will be approximately 19 million, R&D will be 95 million, G&A we are estimating at 17 million. The resulting loss per share for fiscal 2009 will in the range between $2.65 and $2.70.

And with that, I would like to turn it back over to Bob.

Robert E. Conway

Thanks Mike. Let me pass it over to Kevin Koch, Chief Scientific Officer to update you on three specific clinical programs. Kevin?

Kevin Koch, Ph.D.

Good morning. Bob has already discussed the status of several of our programs. I will provide you with some additional details on three of our development programs where key discussions or changes in strategy have occurred over the past quarter.

We disclosed last quarter a new program on a novel small molecule glucokinase activator, ARRY-403 for the treatment of Type II diabetes. According to the Centers for Disease Control, roughly 24 million patients... Americans have diseases... have diabetes. Currently, available therapies for this progressive disease are insufficient or inconvenient, creating a niche (ph) with the development of novel therapeutic approaches.

GKAs represent a promising class of drugs for Type 2 diabetes treatment because in preclinical studies, they are highly effective, have a good safety profile, are orally administered and potentially can be used as either a monotherapy or in combination with existing treatments. Glucokinase activators reduce glucose levels via a dual mechanism of action. Working in both the pancreas and the liver, glucokinase is an enzyme that senses glucose in the pancreatic beta cells, stimulating insulin release in a glucose-dependent manner. Glucokinase also regulates glucose uptake and glucose production in the liver. In diabetic patients, there is a reduction of glucokinase activity in the pancreas and the liver. The activation of glucokinase lowers glucose levels by enhancing the ability of pancreatic beta cells to sense glucose, in turn increasing the level of insulin that is produced by the pancreas.

Simultaneously, glucokinase activators also increase the uptake of glucose in the liver while reducing the amount of glucose produced by the liver. These combined actions of glucokinase activators result in improved beta cell function and increased insulin sensitivity in the liver.

Our data showed that in multiple, well established, in vivo models of Type 2 diabetes, ARRY-403 was highly efficacious in controlling both fastening and non-fastening glucose with a rapid onset of effect in maximal efficacy within five to eight days. In combination with existing standard of care drugs including metformin, PPP4 inhibitors and PPAR agonist, ARRY-403 provided additional glucose control with maximal steady state effects seen after five to seven days of once daily dosing. ARRY-403 showed no adverse increases in body weight, plasma triglycerides or total cholesterol, whether used as monotherapy or in combination.

Based on these and other results, Array plans to advance ARRY-403 into human clinical trial studies this quarter. In our initial trial, we are planning a single ascending dose study in diabetic patients followed by a defined meal challenge to allow us to measure both fasted and non-fasted glucose levels in patients whose glucose levels are not well controlled. This trial should be complete by the end of the second quarter of 2009, allowing us to move quickly into multiple dose studies.

In the oncology area, we have submitted over ten abstracts to the April AACR meeting being held at Denver this year. At that meeting, we plan on disclosing significant information on several compounds in our clinical and preclinical portfolio. In particular, ARRY-543, our ErbB family inhibitor is progressing well in several studies. We have nearly completed our enrollment of the 20-patient Phase 1b study in trastuzumab-resistant ErbB2-positive breast cancer patients and have completed enrollment of ErbB all-comers Phase 1b trial.

We believe the clinical data will show that ARRY-543 is a potent inhibitor of both EGFR and ErbB-2 driven tumors with competitive advantages over Tykerb and other agents currently in development. Given the activity of ARRY-543 against multiple ErbB family member, we believe that we have an opportunity to develop a first-in-class mechanism drug which would show enhanced activity against tumor types, which co-express ErbB family members.

Currently, we are evaluating ARRY-543 in combination studies with capecitabine and, in the future, gemcitabine to identify the optimal combination to test this novel hypothesis and provide a rapid path to approval.

In the area of Herceptin resistant ErbB-2 positive breast cancer, we believe that the Phase 1b data will support the potential of this agent in Herceptin resistant patients without running an expensive control trial in this patient population. Instead, we have initiated a Phase 1b combination study of ARRY-543 with docetaxel to position the product to be moved into a first line ErbB-2 positive breast cancer setting after the drug has been successfully partnered.

Finally, we have decided to position ARRY-614, our p38/Tie2 inhibitor into hematologic cancers indications with our first trial in MDS.

MDS or myelodysplastic syndromes are a heterogeneous group of disorders characterized by impaired blood cell production, accompanied by significant bone marrow abnormalities. With the ageing population and a growing awareness of the disease, the incidents of MDS has increased significantly over the past several years. Over two-thirds of the patients are considered low grade MDS patients with repetitive transfusions as a primary standard of care. Abnormal cytokine signaling, especially from IL-6 and TNF drives down regulation of hematopoiesis. Elevated levels of these inflammatory cytokines have also been observed in the plasma and bone marrow of MDS patients. Increased apoptosis in the bone marrow of low grade MDS patients correlates with upregulated phospho p38 and inhibitors of p38 can restore normal hematopoietic function ex-vivo from patient samples.

ARRY-614 is a potent p38/Tie-2 inhibitor that has demonstrated dose proportional linear pharmacokinetics and significant markdown of MDS relevant cytokines such as TNF IL-1 and IL-6 in ex-vivo pharmacodynamic studies in normal volunteers. ARRY-614 was well tolerated at doses up to 400 milligrams QD with 14 days of dosing and the maximum tolerated dose was not reached. We anticipate initiation of a dose escalation study in low grade MDS patients with ARRY-614 in the second quarter of 2009 with erythroid response and transfusion independence being the primary endpoints.

I'll now hand it back over to Bob to provide clinical milestones for calendar 2009.

Robert E. Conway

Thanks Kevin. Let me review with you on a study-by-study basis our clinical milestones for 2009. And there is a lot of information here.

ARRY-162, our MEK inhibitor for rheumatoid arthritis. In the first quarter of '09, we'll complete enrolment of the Phase 2 RA trial. In the third quarter of '09, we'll have top line results on that Phase 2 RA trial.

ARRY-797, our p38 inhibitor. In the first quarter of '09, we'll complete the high dose multiple ascending dose trial at 1200... providing 1200 milligrams of coverage.

In the third quarter of '09, we will have top line results on a 28-day RA trial in combination with methotrexate.

In the fourth quarter of '09, we'll complete enrolment of the Phase 2 ankylosing spondylitis trial in 170 patients. And in the following quarter, first quarter of '010, we should have top line results on that trial.

ARRY-403, our glucokinase activator for Type 2 diabetes. In the second quarter of '09, we'll complete the Phase 1 single ascending dose trail. In the fourth quarter of '09, we'll complete the Phase 1 multiple ascending dose trail.

ARRY-300, a second generation MEK inhibitor. In the second quarter of '09, we'll complete a Phase 1 single ascending dose trial in normal volunteers.

ARRY-543, our ErbB-2/EGFR inhibitor, we'll, in the second quarter of '09, we'll report results on a 40 patient Phase 1b trail. Half of those patients are Herceptin failed HER2+ metastatic breast cancer patients and the other half are... is in all-comers on ErbB family expressing tumor types.

ARRY-520, our kinesin spindle protein for AML and multiple myeloma. In the second quarter of '09, we'll complete the Phase 1 expansion trial in solid tumors. In the third quarter of '09, we'll have top line results in the Phase 1b AML trial. And in the fourth quarter of '09, we'll complete enrollment on the Phase 1b multiple myeloma trial.

ARRY-380 or ErbB-2 selective inhibitor for metastatic breast cancer. In the third quarter of '09, we'll complete Phase 1 escalating dose trial.

ARRY-614, our p38/Tie2 inhibitor for MDS. In the second quarter of '09, we'll report the single and multiple ascending dose results for the Phase 1 study. And also in the second quarter of '09, we'll initiate a Phase 1b, Phase 2 study in MDS patients.

And finally, during 2009, we plan to raise $80 million through partnerships that would include both upfront payments from new partnerships and milestones from existing partnerships.

Corrine, let me send it back over to you see if there is any questions among the call-in participants this morning.

Question-and-Answer Session

Operator

Yes, certainly sir. (Operator Instructions). We'll take our first question from Cory Kasimov with JPMorgan.

Unidentified Analyst

Hi, good morning guys. This is Mona for Cory. Two questions. One, can you provide just a bit more clarity on the 80 million you're forecasting for calendar year '09? If so, can you break that down into what you expect to receive from existing relationships versus new partnerships?

Robert Conway

Sure, Mona. Dave Snitman's with us this morning. He will provide some more clarity.

Unidentified Analyst

Thanks.

David Snitman, Ph.D.

Yes, we are looking at that being broken down into a series of upfront payments for the licensing of clinical candidates plus upfront payments from licensing of preclinical candidates. And then we are also looking at a little bit of that coming from some head count reimbursement for programs that would support backup programs for some of these as well as milestones from existing collaborations.

Robert Conway

Yeah. And I think we've said at the JPMorgan Conference that around 15 to 17 million of that would be existing programs and the rest would come from a development program and a discovery program.

Unidentified Analyst

Okay, that very helpful. And then just on the new partnerships. I can't remember if you reviewed this, but does this depend at all on the generation of clinical data that's yet to come?

David Snitman, Ph.D.

No, we are in active discussions now with several companies on different programs.

Unidentified Analyst

Okay. And then just another question for you Dave on the glucokinase activator program. Just wondering if you have seen anything... any change either positive or negative since the FDA updated its clinical trail guidance for diabetes drugs. Any effect on the partnership discussions?

David Snitman, Ph.D.

Right. No, I think that does have an impact on the risk factor in any new diabetes program. I think we are aware of that. I think the partners we are talking to are aware of that. And I think that places a premium on a quality drug in this area that doesn't have cardiovascular risk. We think that ARRY-403 fits into that category and we are also getting feedback from our partners that this is also something of interest to them. So I think that's just the world that we live in today and so I don't really see it change.

Unidentified Analyst

Okay. Thanks very much.

Robert Conway

Okay. Thanks Mona.

Operator

We'll take our next question from Edward Tenthoff with Piper Jaffray. Mr. Tenthoff, your line is open. Sir, we are unable to hear you. (Operator Instructions). Hearing no response, we'll move on to John Sonnier with William Blair.

Tim Lugo - William Blair & Company

Good morning. This is actually Tim Lugo for John. I had a quick follow-on question for the 80 million in funds through this new partnership. Is this going to cover one compound, four compounds? Can you give us a range there?

David Snitman, Ph.D.

Seeing that we don't have deals completely signed yet, we think that this will be spread over two, possibly three programs.

Tim Lugo - William Blair & Company

Okay, that's fine. Thank you.

Operator

And we'll move on to Simos Simeonidis with Rodman & Renshaw.

Simos Simeonidis - Rodman & Renshaw

Hi, thanks. My questions have been answered.

Robert Conway

Okay.

Simos Simeonidis - Rodman & Renshaw

Thanks.

Operator

(Operator Instructions). And we'll take a question from Edward Tenthoff with Piper Jaffray.

Edward Tenthoff - Piper Jaffray

Great. Thanks. Sorry, I missed out earlier, toggling between calls. So obviously a lot going on at AACR this year. Kevin, I think you mentioned, how many abstracts do you have total submitted?

Kevin Koch, Ph.D.

Well, we've submitted more than 10.

Edward Tenthoff - Piper Jaffray

More than 10. Great.

Kevin Koch, Ph.D.

We don't have any acceptances. We don't know what the acceptance rate will be. We anticipate quite a few programs will have other posters. We know we'll be having a presentation on 520, educational session on Saturday.

Edward Tenthoff - Piper Jaffray

That will be for AML probably?

Kevin Koch, Ph.D.

Well, it will probably be more preclinical and some early clinical data. But we're still discussing what would be the best timing for a disclosure of the clinical data and around 520 and whether a meeting more like ASH would be more appropriate for the discussion, although, we... I think we... that's still in discussions with the primary investigator.

Edward Tenthoff - Piper Jaffray

Now would you guys have an event or something to kind of recap everything?

Robert Conway

We haven't decided on that yet, Ted. It's under evaluation. Unfortunately, it's here in Denver, so it's very convenient for us.

Edward Tenthoff - Piper Jaffray

Yes, I think it would be a good opportunity, especially to kind of give a review of what's at AACR and then kind of touch on the programs more broadly. Tell me a little bit more about ARRY-300. Obviously, a MEK inhibitor that you're taking into Phase 1s now. What are kind of your longer term plans here just as it fits into the overall MEK portfolio both on the cancer side and on 162 for inflamm?

Robert Conway

Well, this is a second generation MEK inhibitor that we have right now. We are testing in a single ascending dose trial to establish its tolerability, its pharmacokinetics and its pharmacodynamics. And then once we get those results, we can look at a variety of different options for taking the drug forward. And there is, as you know, Ted, as you know, there is a tremendous number of diseases that this drug could be tested in. And we're in an evaluation process right now as to where to take it without any final decisions having been made.

Kevin Koch, Ph.D.

And we would... and Ted, we would anticipate... this is Kevin... we would anticipate being able to, again, as we did with the AstraZeneca collaboration, perhaps with indications of... and having two MEK inhibitors that we own 100% gives us the maximum optionality. As you saw I think probably three, four weeks ago, there was a company who licensed a RAF inhibitor to Roche-Plexxikon for a polycystic kidney disease. We've also run studies in that area in animal model and show knock down of ERC in the kidneys of those animals. So I think that there is a lot of opportunities for MEK inhibitors and we are leaving all options on the table.

Edward Tenthoff - Piper Jaffray

Great, excellent. Just lastly, if I may, on 543, I was listening and caught most of what the larger plan was there. So can you refresh, which studies are ongoing right now? What is the current status of those? And then explain to me a little bit more about this front line strategy with docetaxel?

Kevin Koch, Ph.D.

Okay. So it is a little bit complicated. And to some extent it's being driven be the cost and difficulty of working in the Herceptin resistant HER2+ breast cancer patient population. So how we've thought of this is that we have the 1b data coming out hopefully at AACR and HER2+ in Herceptin resistant breast cancer patients. We believe that that data will show that we differentiate from other compounds in the field and have activity that would allow one to develop the drug in that therapeutic area. So we've made an investment there and we think it's positive enough that people will look at the data and say yes, there is a potential path in that area.

At the same time, we've also seen activity in EGFR+ patients. And, how we think of this is that when we look to differentiate the product that we are really the only agent that inhibits EGFR and ErbB-2 simultaneously at levels we think will be efficacious. And we've shown that in preclinical studies. I think we have some clinical data to perhaps support that.

So how we think about the product is that we are going to look at the optimal combination, so we have... the capecitabine study is ongoing with 543, a gemcitabine combination study will be initiated shortly and a docetaxel combination trial with 543 has been initiated and we are actively enrolling.

So what does this do for us? It allows us to take the drug in a first line setting as a true dual inhibitor in dual expressing tumors probably in combination with either cape or gemcitabine at the same time showing tolerability and efficacy with docetaxel in first... in all-comers and then ultimately in breast cancer patients allows us to go directly to a first line setting in Herceptin resistant HER2+ patients or first line ErbB2+ patients. So one of the problems is the cost of doing the ErbB2+ breast cancer is very high right now. And when we'll have to... we start doing a non-inferiority trial which will be very large and will take a very long time.

The way we are actually running the program is by running these three combinations and then running a very well defined Phase 2 study in a tumor type where there either is no standard of care or the standard of care is very poor, in particular some of the GI tumors like gastric, esophageal, pancreatic or bilarate (ph), we should be able to have a faster development path and also have the upside of having activity in the breast cancer patient population. So that's a long winded answer.

Edward Tenthoff - Piper Jaffray

No, that's very helpful.

Kevin Koch, Ph.D.

A very complicated development strategy, but I think from talking to our partners and our collaborators and our thought leaders, this is the right path for the compound.

Edward Tenthoff - Piper Jaffray

That's very helpful. Thank you.

Operator

And there are no further questions at this time. (Operator Instructions) And we'll take another follow-up question from Edward Tenthoff.

Edward Tenthoff - Piper Jaffray

Well since I have got the mike, I figure we can talk about this stuff all day long, right? Just picking up maybe where we left on, Kevin, on 543, that's helpful, and David maybe you chime in on this. How do these studies kind of change or position 543 as a partnerable asset? Do you think the 1b data is enough or would you prefer to take them through these studies you have ongoing? Again, it's sounds like a relatively cost effective approach to get a potential kick up in value of that drug.

David Snitman, Ph.D.

Yeah, Ted, let me answer that. So I think that the data that we will present at AACR will clearly define 543 as a drug that, as Kevin says, has dual activity. I think that's a very attractive profile and we are in discussions with companies on 543. I think moving it forward in first line in non-metastatic breast cancer setting where we can clearly show that we are a drug that works in tumors that really have no treatment would add a great deal of value. That's our path, that's what we're going to be proceeding. And if we find the right value for 543 along the way, we will do a deal there.

Edward Tenthoff - Piper Jaffray

So maybe to discuss a little bit more on the deal side, as you lay out this pipeline, what are the one... what are the assets that to you make the most sense to partner at this point either due to expertise, due to potential interest from partners or just due to... this is something that we'd really like to partner?

David Snitman, Ph.D.

So we're looking to partner programs that can best benefit by increasing the breadth of the clinical development program and as well as once where a large commercial presence would make sense. For example, ARRY-403, our glucokinase activator is a prefect example where we think a partnership here makes a lot of sense in terms of the regulatory issues, the breadth of the clinical program that has to be run and the commercial potential where, to be successful in diabetes, you have to probably be over $1 billion dollar in sales, so. Then thirdly, giving our expertise in clinical development is on inflammation and oncology adding a third clinical expertise to Array doesn't really make sense at this time. So that's a perfect example of how we think we're matching a partnership with a program and looking to... we are in at active discussions with several companies on that program.

Edward Tenthoff - Piper Jaffray

Perfect. Good, I think that's helpful. Thank you.

Robert Conway

Thanks Ted.

Operator

And we'll take another question from John Sonnier with William Blair.

Tim Lugo - William Blair & Company

This is Tim again. Thanks for taking the follow up. Not to continue the 543, talked too long. But are you still looking at it as a competitor to Tykerb, or are you now looking at the pertuzumab and DM1 datasets as possible comparisons? And how will those influence your development?

Kevin Koch, Ph.D.

Yes, those compounds have significant activity. And that's part of the complicated and heavy competition in the field. Now do we believe that we can outcompete those products? I think we can. The problem is and what we've decided entirely is that investments, multiple investments north of $10 million, even in 14, 14 million for this particular trial as well as a very competitive landscape does not fully take advantage of the attributes of this compound. And we really stepped back and said, what really clearly differentiates this product?

What differentiates the products is that it hits two targets simultaneously with enough potency to actually make us believe that we can work in dual expressing tumors. So we believe we can compete in the breast cancer area. However, we think that we have a faster approval path in other tumors where there is a much more significant unmet medical need and really no competition. And we can do it for a third of the price.

Tim Lugo - William Blair & Company

That's very helpful. Thank you.


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