Nastech Pharmaceutical Q3 2007 Earnings Call Transcript

| About: Nastech Pharmaceutical (NSTK)
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Nastech Pharmaceutical Company,Inc. (NSTK) Q3 2007 Earnings Call October 30, 2007 4:30 PM ET

Executives

Ed Bell - IR

Steven Quay - Chairman,President, and CEO

Gordon Brandt - EVP, ClinicalResearch and Medical Affairs

Phil Ranker - CFO

Analysts

Mark Monane - Needham & Company

Bino - Thomas Wiesel Partners

Robert Uhl - FBR

Operator

Good day ladies and gentlemen,and welcome to the third quarter 2007 Nastech Pharmaceutical Earnings Call. Myname is Katina, and I will be your coordinator for today. At this time, allparticipants are in a listen-only mode. We will conduct a question-and-answersession towards the end of this conference. (Operator Instructions). As areminder, this conference is being recorded for replay purposes.

I would now like to turn thepresentation over to your host for today's call, Mr. Ed Bell, Director ofInvestors Relations. Please proceed.

Ed Bell

Good afternoon and thank you forjoining today's conference call to discuss Nastech's highlights and financialresults for the quarter ended September 30, 2007.

With us today are Dr. StevenQuay, Nastech's Chairman, President, and Chief Executive Officer; Dr. GordonBrandt, Nastech's Executive Vice President of Clinical Research and MedicalAffairs, and Phil Ranker, Chief Financial Officer.

At 4:00 pm Eastern Time today, wereleased financial results for the third quarter ended September 30, 2007.During today's call Dr. Quay will review recent corporate activities, Dr.Brandt will review the clinical and regulatory updates, and Mr. Ranker willdiscuss our third quarter financial results. Following our formal remarks, wewill open up the call to your questions.

Before we begin, I would like tonote that comments made during this call may include forward-looking statementsregarding future events or the future financial performance of the company.Such statements are predictions only, and actual events or results could differmaterially from those made in any forward-looking statements due to a number ofrisks and uncertainties, including assumptions about future events based oncurrent expectations; planned business development efforts; near and long-termobjectives; potential new business strategies or organizational changes;changing markets; future business performance; and outlook.

I refer you to our most recentfilings with the SEC including, without limitations, Forms 10-K, 10-Q and 8-K,which contain all material information about us including risk factors.

I will now turn the call over toDr. Quay.

Steven Quay

Thank you and good afternoon.During the third quarter of 2007, we continued to make significant progress onour programs with the initiation of two new Phase 2 trials; one with our PYYNasal Spray Program for obesity; and the second with our Insulin Nasal SprayProgram for diabetes.

We’ve also continued to workclosely with our partners to progress our programs, including helping P&GPharmaceuticals to evaluate available biomarker data and then determine theappropriate next steps in the clinical program for PTH Nasal Spray forosteoporosis, and performing significant development work with Novo Nordisk.

On the RNA front, we continue tobuild and develop our technology platform, and take steps to increaseshareholder value for the assets we have developed and acquired.

Let me welcome and tell you alittle about a new member to Nastech’s Executive Team. This month we announcedthat Rick Costantino was promoted to Chief Scientific Officer of Delivery. Rickhas been with Nastech in a senior management role since 2003.

Prior to joining Nastech, hespent about five years at Alkermes, Inc. working on research and development ofpolymer-based technologies or a sustained delivery of peptide and proteintherapeutics, and served as a key member in managing external collaborations.

Prior to that, he spent aboutthree years in Genentech, Inc. as a research scientist in their pharmaceuticalresearch and development group. Rick will lead our delivery programs, includingnasal peptide and protein delivery, as we further advance our currenttechnologies. Rick’s presence at Nastech and his prior leadership role willensure continuity in our research and development programs.

Now I'd like to turn the callover to Gordon for a discussion of current clinical and regulatory programs.

Gordon Brandt

Thanks Steve. Let me begin thediscussion with our PTH Nasal Spray Program. As previously mentioned, P&Gcontinues to work on the Phase 2 development program, and we are helping themto evaluate available biomarker data and then determine the appropriate nextsteps in the clinical program for PTH Nasal Spray for Osteoporosis.

The market for PTH treatmentcontinues to expand. The injected form of PTH recorded annualized sales of $720million and a 21% increase year-over-year in the most recent fiscal quarter forLilly. A nasal spray form of PTH should be well received; for example, theviews of Dr. Robert Lindsey, osteoporosis expert at the Helen Hays Hospital, were expressed at our recentAnalyst Day.

He reviewed the efficacy andpotential future use of PTH in treating osteoporosis, and identified the dailyinjections required by the currently marketed product as one of the keybarriers to significantly expanding its use. He also confirmed the only bonegrowing or anabolic therapy is the PTH class of drugs.

Finally the safety concerns withdevelopment stage products that are administered through the lungs reduces theprobability of success for these earlier stage Inhaled PTH programs, making anintranasal PTH program that much more attractive.

In the second program to discusstoday, we continue to work closely with Novo Nordisk, as one could surmise fromthe fact that Novo contributed 48% of our contract research revenue thisquarter. We are pleased with the way this program is advancing throughdevelopment.

Moving onto our Insulin NasalSpray program, as we announced we've initiated a Phase 2 glucose tolerancestudy. The study will be a randomized cross-over study, evaluating insulinnasal spray versus a rapid-acting injectable insulin on post-meal glycemiccontrol in patients with type 2diabetes.

As many of know, hemoglobin A1cis a measure of glycemic control. The higher it is, the worst the glycemiccontrol, and thus more likely of diabetic complications, including renalfailure, heart attacks, blindness, and even premature death.

Diabetics typically start on oralmedicines and long-acting insulins. These medicines take care of averageglucose level, but tend not to work very well on the post-meal glucose excursions.Therefore diabetics run into a limit on how much their A1c can be reduced withcurrent therapy.

The goal of our nasal insulin isto decrease the glucose rise after a meal, thus helping diabetics reach theirA1c goal. The glucose tolerance study which is ongoing will compare the nasalspray insulin with a rapid-acting injectable insulin.

These types of studies were notlengthy, so we would expect it to be available from the study in the first halfof 2008. As most of you are aware, Pfizer announced in their third quarterreport that they will discontinue marketing Exubera, an inhaled form of insulinthat is delivered to the lungs.

I believe that some of the marketissues that contributed to Pfizer's decision were concerns over the long-termpulmonary safety, modest meal time efficacy, issues with the somewhatcumbersome device, and finally the price. We tested Exubera in a head-to-headstudy against our intranasal insulin, and confirmed Exubera's lowbioavailability and slow onset of action.

As a reminder, one of the keyparameters designed in to all nasal spray products is the demonstration of thelack of delivery to the lungs, thereby eliminating safety concern in the lungs.

So the issues about a decrease inpulmonary function or the requirement for periodic pulmonary function testingsimply don't apply to a nasal product. As you know our device is the size of alipstick applicator or a pack of gum, compared to the tennis ball can size ofthe Exubera device.

For all these reasons, we believethe discontinuation of Exubera further supports the intranasal route ofdelivery, and may bring in to question the likelihood of success for some otherinhaled program under development.

Although pulmonary delivery mightstill have application for certain therapies, such as short-term delivery oftherapeutics for pulmonary disease including influenza. We believe thatNastech's intranasal technology is well suited for systematic delivery ofpeptides.

With respect to PYY for obesity,we announced that we've initiated a multi-centered Phase 2 study. The studywill enroll approximately 500 obese patients at 29 centers around the countryin a six months randomized placebo-controlled dose ranging study, including anactive treatment arm with an approved oral medication, with weight loss as theprimary end point.

The Phase 2 study design willevaluate a 200, 400 and 600 microgram dose of PYY nasal spray. The study designwill enable patients to undergo an initial dose titration period to establishan optimal dose for each patient to continue over the duration of the trial.

So, for example if a patient israndomize into the 400 or 600 microgram dose group, they’ll first start to 200micrograms for one week, and then advance to 400, and then to 600. If thehigher doses are not tolerable for the individual, they will revert to thepreviously tolerated dose.

Biologically active peptides,particularly the GI peptides often require dose titration to enable the body toadjust to the medication, as is typically done, for example, for the marketedproducts Byetta or Symlin.

Therefore the goal of this doseoptimization period is to identify a dose that the patient can stay on for thefull length of the trial. Patient enrollment is going rapidly with over 250patient screened and over 50 having received drug as of this morning, pointingat the critical need for improved obesity treatments.

Next, let me discuss ourCarbetocin nasal spray for autism. We’ve now completed two Phase 1 clinicalstudies of Carbetocin for the treatment of the core symptoms of autism. Thepurpose of these trials is to test multiple formulations with tolerance andbioavailability as the endpoints.

We’re currently completing anIND-enabling toxicology program, so that we can begin to do trials in the US. There aretotal of 16 pre-clinical toxicology studies for that IND, and we’ve completed 10 of those studieswith no unusual or unexpected findings.

Next up our dose ranging studiesin healthy volunteers. At this time, we plan to conduct brain imaging studiesto evaluate the doses at which Carbetocin increases activity in areas of thebrain known to be important in autism.

We also plan to conductadditional neuropsychological studies, with rising dozes of Carbetocin, toevaluate the doze response for tasks such as correctly interpreting emotionalcontent of images or voices. The study design of these complex trials is beingassisted by working with experts in the field. We would expect to begin Phase 2trials in the first half of 2008.

Finally, with regard to ourgeneric calcitonin program, we've answered all issues and questions from theFDA. The ball is in their court, and we continue to wait for the outcome ofFDA's review of our abbreviated new drug application.

At this point I would like toturn the call back to Dr. Quay for an update on the RNA based programs.

Steven Quay

Thanks Gordon. Nastech is focusedon becoming a leader in the area of RNA based therapeutics, by developing aproprietary package to deliver this therapeutics to silence gene expressionsfor the treatment of both acute and chronic diseases.

Nastech has developed a secondgeneration technology platform for the three key components of RNA-basedtherapeutics. Namely; the building blocks, comprising rival thymidinemodifications which reduce toxicity, the therapeutic cargo, usingDicer-substrates to improve efficacy and also reduce toxicity, and finallydelivery, using covalent peptides and lipids for getting RNAs into tissues andorgans.

In therapeutic areas, we want todevelop and partner above RNA therapeutics initially in rheumatoid arthritisand influenza, and also MicroRNA therapeutics in cancer and heart disease. Andfinally, we want to participate in a collaborative fashion with the developmentof In-vitro Diagnostics based on disease-specific expression profiles ofmessenger RNA, MicroRNA, and other sequences to assist in both clinicaldevelopment and in market adoption of these new medicines.

We will continue to collaboratewith leading companies and academic and government laboratories. Our past andcurrent collaborators include the Hellenic Institute in Greece, the Mayo Clinic, Universityof Washington, Dharmacon in Colorado, City of Hope andISIS in Southern California, the Universities of Iowa and Michigan,the CDC in Atlanta, the Universite Laval in Quebec, MIT, Galenea and Alnylam in Cambridge Massachusetts,Cogenics, NIH, and finally the Carnegie Institute.

With our platform capabilities,we've demonstrated in pre-clinical models. One, efficient knock in the (inaudible)range of siRNAs. These are doses that are approximately one million times morepotent and currently used risk substrates, efficacy against the influenza virusincluding H5 and 1 Avian flu, and the ability to reduce TNF-alpha expressionand thus the inflammation associated with rheumatoid arthritis through systemicdelivery. These advances are important as we move towards the clinic with oursiRNA programs

MDRNA, Inc. is Nastech’swholly-owned subsidiary focused on developing RNA-based therapies. The Board ofDirectors has been provided with management's recommendation as to the processof increasing shareholder value for this set of assets, and they will be makingtheir decisions on next steps in due course. We will update you on our futureplans when their decisions is made

I'll now turn the call over toPhil for comments on the third quarter's financials.

Phil Ranker

Thanks, Dr. Quay. We will startwith the Phase 2 studies for PYY and insulin, the efforts are underway todesign the Carbetocin Phase 2 program, and the further advancement of ourtechnologies for the delivery of biotherapeutics demonstrate that Nastech issuccessfully executing our business strategy by taking our products further indevelopment

We believe the investments we aremaking in these programs and to broaden our technology base, are important tocreate a long term shareholder value. We now review the results of the thirdquarter of 2007.

Revenue for the quarter endedSeptember 30, 2007 was $1.9 million compared to $5.5 million for the thirdquarter of 2006. The 2006 period included higher revenues primarily due to thedevelopment activities Nastech was conducting under the collaborative agreementat that time.

Revenue for the current quarteris associated primarily with reimbursement revenue from our partners andproduct manufacturing revenue for Nascobal. The net loss for the currentquarter was $16.5 million or $0.66 per share, compared to net loss of $7.8million or $0.36 per share for the prior year period.

The increase in our net lossresults from a combination of lower revenue due to the timing of reimbursedcollaboration activities, higher spending due to increased clinical activities,which included the Phase 2 trails of PYY and insulin, as well as headcount growthand expenses related to our other R&D projects.

Specifically, our total R&Dexpenses increased by $3.3 million to approximately $13.8 million for thecurrent quarter compared to the same period of 2006. Selling, general andadministrative expenses for the current quarter increased by $1.6 million fromQ3 of 2006, to approximately $5.1 million for Q3, 2007.

This increase is primarily due tothe patent and legal costs necessary to support our business model andcorporate structure, as well our growth. With respect to our current financialresources, we ended the third quarter of 2007 with approximately $58.1 millionin cash, cash equivalents and investments compared to approximately $51 millionat December 31, 2006.

This concludes my comments. Wewill now open today's call to your questions.

Question-and-Answer session

Operator

Thank you. (OperatorInstructions). Your first question comes from the line of Mark Monanerepresenting Needham & Company. Please proceed.

Mark Monane - Needham& Company

Hey, thank you. Good afternoonand thanks for taking my call. Congratulations on your progress so far.

Gordon Brandt

Thanks Mark.

Mark Monane - Needham& Company

With respect to progress, couldyou outline for us what’s the great learning step on the P&G program, thePTH. Is the biomarker data necessary for moving a trial forward, are thereother limitations there, and what would be the rate limits there for starting aPhase 3 trial here?

Gordon Brandt

Thanks Mark, this is GordonBrandt. I am sure you will appreciate that it's difficult for us to commentmore. We are obviously working closely with our partners Procter & Gamble,and they are really controlling the information flow on this program forcommercial and scientific reasons.

So as we said last year,biomarker studies are starting, then studies with an additional endpoint willfollow thereafter, and those would be expected to model the Phase 3 studies. Soit’s an ongoing process, and we’re actively working on it, but unfortunatelybeyond that I am afraid I can’t share too much additional.

Mark Monane - Needham& Company

That’s fair. And in terms of thedose response curve for PYY program. We’ve heard that the curve for satietygoes from hunger satiety, nausea and vomiting, where if you have too high dosesyou start to get side effects; whereas smaller dose might give you the satietywithout the nausea and the vomiting. For many of your earlier biomarkerstudies, is there any indication which dose might be the preferred dose at thispoint and how longer [guessing], of course this will influence how longer trialtakes?

Gordon Brandt

Sure. The collected informationthat we have on PYY so far suggests a couple of things. Number one; whetherit’s delivered IV or intranasal one gets the same kind of efficacy. Number two;each individual patient may have a different doze, which works best for them,and that’s why we have emphasized the doze optimization aspect of this study.

So again depending on what groupyou randomized to. If you get randomized to one of the higher doses of nasalPYY, you will be given a week at each of the lower doses to try to getaccustomed to it. So, we've seen differences at least in the pharmacokineticprofiles, the amount of drug in the blood from one patient to the next, given thesame dose, and so we want to give the patient an optimized dose for eachindividual person. I am not sure that that captures the answer to yourquestion. Did you have a more specific question in mind?

Mark Monane - Needham& Company

Not really. I am interested inthe variability from person to person. What's the basis of that variability? Isthe PK difference or is it a PD difference to your knowledge?

Gordon Brandt

I think on this particularprogram, since the new molecule, the PK – PD pharmacokinetic, pharmacodynamicrelationship is still being determined. But what we find is that the effectfrom patient to patient seems to vary, and some we expect will do better on 200and some better on 400. So, again we want to give the patient the optimal chancehere.

Mark Monane - Needham& Company

Terrific. Thanks for the addedinformation.

Gordon Brandt

Sure.

Operator

(Operator Instructions).Representing Thomas Wiesel Partners, your next question will come from the lineof Bino. Please proceed.

Bino - Thomas Wiesel Partner

Hi, congrats on what progressyou've have made so far. And I have a couple of, two or three questions. Firstone about the RNA program, if I remember correctly you had planned to bring inadditional vectors to your RNA subsidiary. Is that plan still like that or doyou plan to continue with the subsidiary [under you] overtime?

Steven Quay

Yeah, Dr. Quay here. I want totell you that you are very, very faint, and so I will restate and capture theessence of your question. If you could speak up just slightly it would bebetter. I think you asked, do we intend to get additional investors in the RNAeffort going forward? And I think as I indicated today on the call, we areworking closely with our Board of Directors on a specific plan for thatprogram. At this point in time it would be pre-mature to talk about the optionsthat are being considered.

Bino - Thomas Wiesel Partner

Right. Hope I am more audible now

Steven Quay

Yes it’s much better, thank you

Bino - Thomas Wiesel Partner

Are you looking at pharmaceuticalpartners or investor partners towards that?

Steven Quay

Again that program will be likeNastech’s program in which there will be both investors who purchase equityperhaps in that, as well as having pharmaceutical partners down the line. Butit’s premature to indicate either of those

Bino - Thomas Wiesel Partner

Right – right – right. And areyou at a stage way can you give a very rough guidance as to when it mighthandle the clinics, the RNA or any of the early standard RNA program?

Steven Quay

No we are not prepared to that

Bino - Thomas Wiesel Partner

Okay, great. Let's say could be asecond question, just follow-up to Mark's question about PYY. I think I missed,what will be the time you would be taking in to titrate the best dose for eachpatient?

Gordon Brandt

Thanks, this is Gordon Brandt.When titration is appropriate, in other words when a patient is randomized tothe nasal PYY doses, it's a week at each of the dose. So you have a week to getused. And obviously because the patients don't know what they have beenrandomized to anybody who is on any of the nasal spray groups whether it'splacebo or 200, 400 or 600 will have the same four week titration period. So ina four week of time you would have the opportunity if you had been randomizedto the highest dose to go 200 for a week, 400 for a week, 600 for a week, andthen if you couldn't tolerate that drop back down to 400. So it's a four weekperiod for everyone in the study.

Bino - Thomas Wiesel Partner

Okay. And following that thenthey will monitored for six months?

Gordon Brandt

That's correct

Bino - Thomas Wiesel Partner

Okay. So roughly I can expect theresult to come out by end of next year?

Gordon Brandt

Yes, I think that would be appropriate.

Bino - Thomas Wiesel Partner

Great. Next question about theinsulin, can I get the exact end points of the [stricter insulin] study?

Gordon Brandt

I am sorry can you ask one moretime?

Bino - Thomas Wiesel Partner

Yeah. I am looking at exactlywhat the end points of the current Phase 2 insulin study is?

Gordon Brandt

Got it, okay the end points. Thegoal is glucose tolerance, and really what we are looking for is how well wecan control the rising glucose after a standardized meal? So each subject willget a standardized meal, and they would be titrated on to a dose of the rapidlyacting injectable insulin, the commercially available products to figure outexactly for this standardized meal what that appropriate dose is, and then wesee what happens after the meal, how high the glucose goes?

We did the same thing for thenasal spray, the insulin nasal spray dose, and the goal is to see thesuppression of glucose after the meal, so that you don’t get a very high rise.For example, a type II diabetic may have a rise of 100 or 150 or 200 milligramsper deciliter after a meal and the goal is to keep it at less than 60milligrams per deciliter.

Bino - Thomas Wiesel Partner

Okay. How long is the durationfor which each patient will be in that study?

Gordon Brandt

Really it’s a randomized study,so it’s essentially one meal at each dose. However, it takes many test mealsgetting to that one meal, before you know the exact dose that needs to betested. So it’s essentially one day study, a one meal study. Once you finallyoptimized the doses.

Bino - Thomas Wiesel Partner

Okay. So there is no point inlooking at long-term things like HbA1c etcetera, right?

Gordon Brandt

That’s correct. This is not astudy with A1c as an endpoint. The duration of treatment is too short

Bino - Thomas Wiesel Partner

Right, right. And on the PTHprogram, I am just wondering what kind of biomarkers are involved. Is it likesome proprietary biomarkers which you have found out or are they just thepublicly known biomarkers for bond formation which is being studied against thedrug?

Gordon Brandt

We haven’t specifically said whatthe biomarkers are, but if you look at the literature for osteoporosis, as yousay, there are a large number of well understood and well accepted biomarkers.And so it would be reasonable to assume that that’s the area of study.

Bino - Thomas Wiesel Partner

Okay. And then do you expect awith the second Phase 2 study to start within this year, within the end of thisyear?

Gordon Brandt

I regret that I cannot give youclarity on timing. That kind of information will have to come from Procter& Gamble.

Bino - Thomas Wiesel Partner

Right. Any new updates on theExenatide program?

Gordon Brandt

I do not have an update Exenatideprogram at this time. The last available information again controlled by theAmylin Corporation was that they were in the clinic as of about last year thistime with Exenatide.

Bino - Thomas Wiesel Partner

Great. That’s it. Thank you verymuch for taking my questions.

Gordon Brandt

Thank you for your questions.

Operator

(Operator Instructions). Yournext question comes from the line of Robert Uhl, representing FBR, pleaseproceed.

Robert Uhl - FBR

Thank you. So is there anyclinical trial ongoing now with PTH or you finished up the biomarker and youare analyzing it and you are kind of just waiting for the next one to begin?

Gordon Brandt

Robert, I wish I could give youbetter clarity. But again the advantage and the disadvantage of having a greatpartnered program is that I have to differ to my partner for information flow.

Robert Uhl - FBR

Okay, but when you do startanother one you are supposed to get a milestone payment aren’t you?

Gordon Brandt

As we described last year when westart an additional Phase 2 study, yes a milestone payment is expected to becoming.

Robert Uhl - FBR

Okay. And you have not made thatannouncement?

Gordon Brandt

That announcement has not beenmade.

Robert Uhl - FBR

Okay. In that revenue mix, areyou getting revenues from the Exenatide program of any significance at themoment?

Phil Ranker

Robert this is Phil Ranker. Wedisclosed our product revenue in the Q.

Robert Uhl - FBR

Yeah.

Phil Ranker

With the table. I don’t believethat the Exenatide revenues are sufficient enough to be a separate line item atthis point. Otherwise it would have been broken out.

Robert Uhl - FBR

Okay, alright. Thank you.

Operator

This concludes the time we havefor the question-and-answer session. I would now like to turn the call back toDr. Quay for closing remarks.

Steven Quay

Thank you for you questions andattention. Nastech has developed a strong clinical stage pipeline using ourproprietary drug delivery platform with three products in Phase 2 developmentand a fourth program which may enter Phase 2 in the first half of next year.

We also have multiple productsand technology partnerships that are important in driving our business to thenext level. We appreciate your support and thank you for joining us on the calltoday. Good afternoon

Operator

Ladies and Gentlemen, thank youfor your participation in today's conference. This concludes your presentation.You may now disconnect and have a great day.

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