Accel Entertainment, Inc.
Q4 2007 Earnings Call Transcript

Published: 15 Oct 2007

[Operator:]

Greetings and welcome to the Alfacell quarterly updateconference call. (Operator Instructions) As a reminder, this conference isbeing recorded. It is now my pleasure to introduce your host, Larry Kenyon,Executive Vice President and Chief Financial Officer. Thank you, Mr. Kenyon.You may now begin.

[Lawrence A. Kenyon:]

Thank you. Welcome, everyone and thank you all forparticipating in the inaugural Alfacell Corporation quarterly update conferencecall for investors and analysts. As you know, my name is Larry Kenyon and I amAlfacell's Executive Vice President and Chief Financial Officer. With me todayis our Chairman of the Board and Chief Executive Officer, Tina Shogen. Before we begin, please allow me a moment to read our SafeHarbor statement. This presentation includes statements that may constituteforward-looking statements usually containing the words believe, estimate,project, expect, or similar expressions. Forward-looking statements involverisks and uncertainties that could cause actual results to differ materiallyfrom the forward-looking statements. Factors that would cause or contribute tosuch differences include the risks discussed in the company’s periodic filingswith the Securities and Exchange Commission. By making these forward-lookingstatements, the company undertakes no obligation to update these statements forrevisions or changes after the date of this release. Thank you for your patience. I will now ask Tina to reviewour fiscal 2007 accomplishments and our outlook for fiscal 2008.

[Tina Shogen:]

Thank you, Larry. Good morning, all. 2007 was a year ofgreat progress at Alfacell that has positioned us for a successful 2008. Mostimportantly, we began submissions of our ONCONASE rollingNDA in February and we expect to complete the rolling NDA submission withinfour months of reaching 316 evaluable events in our confirmatory Phase IIIbregistration trial of ONCONASE in undetectable malignant mesothelioma. We arecurrently at 295 evaluable events and continue to expect to reach 316 events bythe end of this December. Assuming that the clinical trial issuccessful, we expect to complete the NDA submission by April 30th of 2008. Wewill be able to confirm this date after we reach the 316th evaluable event. Our current plan also includes thepresentation of the data from our confirmatory trial at the Scientific Forum bythe end of -- by June, 2008. Additionally, we continued to make progress in 2007 in our Phase I/II clinical trial program for ONCONASE in solidtumors. While we await the completion of the dosing of the final few patientsin Phase I, we are finalizing our plans for the Phase II component of thestudy. We continue to expect to launch the beginning of the Phase II clinicaltrial program by the end of this December. Fiscal 2007 also saw us enter into ourfirst two commercial agreements for ONCONASE. We have now partnered withGENESIS Pharma in Greece and Southeast Europe, and U.S. Pharmacia in Poland andNortheast Europe. In both agreements, we are entitled to receive milestonepayment and double-digit royalties. Additionally, U.S. Pharmacia paid us $1.5million in an up-front fee and equity investment. Dialog continues with other potentialONCONASE partners and we are optimistic about completing additional agreementsin 2008. Our collaborators have been very busy in2007 as well. During the fiscal year, numerous publications were announced thatdescribe pre-clinical research of ONCONASE, as well as [inaudible]. Dr. Intae Leeof the University of Pennsylvania and Michael Carbone’s laboratory at theUniversity of Hawaii each presented ONCONASE data at the 2007 AACR annual meetingthat enlightened their work with ONCONASE in breast cancer and lung cancer, aswell as mesothelioma. We are also very pleased to see thatONCONASE was included in the latest edition of the Handbook of TherapeuticAntibodies as the ribonuclease of choice in therapeutic antibody research. Finally in July, we completed our moveto our new facility in Somerset, New Jersey. We believe that our corporateheadquarters are adequate for our needs as we advance to our next phase ofcorporate development. I will now ask Larry Kenyon to reviewthe fiscal 2007 financial results.

[Lawrence A. Kenyon:]

Thank you, Tina. As we announced in thismorning’s news release, our fiscal 2007 net loss was approximately $8.8million, or $0.19 per share, an increase of approximately $1 million comparedto fiscal 2006. R&D expenses increased by approximately $300,000 versusfiscal 2006, primarily as a result of increased compensation expense fromemployee stock option grants. Additionally, general and administrativeexpenses increased by approximately $1 million compared to fiscal 2006. Thisincrease was also primarily related to increased compensation expense fromemployee stock option grants, but also included increased investor relationsexpenses as the company began utilizing the services of an investor relationsfirm in fiscal 2007. These increased expenses were offset byincreased investment income of approximately $300,000 and increased proceedsfrom the sale of our state tax loss benefit of $200,000 in fiscal 2007. Cash and equivalents on July 31, 2007,were approximately $7 million, a decrease of only $4.5 million in cash andequivalents from July 31, 2006. Inaddition to proceeds from exercises of stock options and warrants, the July2007 cash and equivalents include the receipt of $1.5 million from U.S.Pharmacia, our new partner for ONCONASE in Poland and Eastern Europe. We estimate that our cash andequivalents should be sufficient to allow us to complete the submission of ourONCONASE NDA, assuming a positive outcome for the Phase IIIb clinical trial andassuming that our projected costs for the completion of the NDA are accurate. At this time, Tina and I would be happyto take your questions.

[Operator:]

(Operator Instructions) Our first question is coming from RaymondMyers of Emerging Growth Equities.

[Raymond A. Myers -Emerging Growth Equities:]

Thank you for taking the questions andcongratulations, Tina and Larry, for getting to this point. We are almost tothe un-blinding of our data. In September, there was an announcement of 390evaluable patients and now we’ve -- you’ve said that there’s -- sorry, 290 andnow there’s 295, so there’s five additional. Was that as of today, October15th?

[Lawrence A. Kenyon:]

Ray, that was as of our most recentcount, which is pretty much an ongoing count at this point.

[Raymond A. Myers -Emerging Growth Equities:]

Okay, so help me to understand how weare going to get to 21 more evaluable patients in the next roughly two months.

[Lawrence A. Kenyon:]

Sure. As we’ve discussed in the pastwith both, the number is variable from month to month. On any two- tothree-month period though, we’ve seen average monthly patients adds at a prettyconsistent level which has allowed us to project that 316th event should beexpected to occur by the end of December. If we hit another month and we are stillonly at five patients per month, we’ll have to reassess and see if there is achange in the trend that needs to be reflected, but at this point we’re notconcerned. We still think we can get to 316 events. Additionally, there a number of patientsat this point, once we got to 316 total events, we were able to determine thatsome patients had been technically lost to follow-up, meaning that they hadn’tbeen in contact with any of the particular sites where they were treated for anextended period of time. This is not a large number. It’s less than 10 but weare taking efforts right now and taking measures to track down those patientsand determine their status. So we expect that, given the length oftime that some of these patients have been alive, that it’s not unreasonable toassume that a number of them may have passed on at this point. So the numberthat we are giving, 295, is very conservative. There’s probably a couple morein there and we’ll have more clarity on that in the next month or so.

[Raymond A. Myers -Emerging Growth Equities:]

So it’s not an issue at all that theremay be some patients that are lost to follow-up? Is that an issue for the dataanalysis? What does that mean?

[Lawrence A. Kenyon:]

No, that’s not an issue at all. We’relooking for 316 evaluable events, period. And a few, a handful of patients thatare lost to follow-up is to be expected in any clinical trail.

[Raymond A. Myers -Emerging Growth Equities:]

And can you explain for everyone what itmeans to be non-evaluable? How does that happen and how many non-evaluablepatients have there been to date?

[Lawrence A. Kenyon:]

Well, I’ll answer your second questionfirst; obviously, when we first announced about a month ago that we were at 316total events and 290 evaluable, 26 patients were considered not evaluable andat this point, that number has not changed. Additionally, to be consideredevaluable, patients must meet all eligibility requirements in the study andhave received at least one dose of study drug on the Phase IIIb clinical trial.

[Raymond A. Myers -Emerging Growth Equities:]

And so -- and these 26 patients, whathappened with them?

[Lawrence A. Kenyon:]

You have a number -- you know, some ofthose patients were not -- did not meet all of the eligibility criteria. Acouple of key criteria that’s important to be measured in this study ispatients must be all in groups one through four using the CALGB ranking system,and they cannot ever be more than one prior chemotherapy regimen, and there’s ahost of others too. At this point, I would prefer not to go through a longlist. It’s kind of a laundry list but it can be read if you go toclinicaltrial.gov and look up the ONCONASE Phase IIIb clinical trial.

[Tina Shogen:]

Ray, I think what’s important also toconsider here is that when some of the patients were randomized under controlarm where [inaudible] alone was the drug, they opted not to be included in theprogram so they were never part of the program, although they were registeredto be entered into the program.

[Raymond A. Myers -Emerging Growth Equities:]

So they really -- they wanted the [ALKINASE].

[Tina Shogen:]

Right.

[Raymond A. Myers -Emerging Growth Equities:]

Yeah, well, that’s understandable. Sowhat can we read into it taking longer to reach the 316 events than we hadoriginally forecast? Are patients living longer than you had anticipated or wasthere any -- is it more related to the timing of recruitment or the number ofnon-evaluable patients? What can we read into this?

[Tina Shogen:]

I would suggest we shouldn’t be readinganything into anything until we know what is what. However, obviously we dohave some patients that have been on the study for a very long period of timeand that is a fact. So we will see what is once we have the event and oncestatistical analysis or databases are curried and locked, then we will knowexactly how each patient fairs.

[Raymond A. Myers -Emerging Growth Equities:]

Okay, great. And then one finalbookkeeping point; what is the fully diluted share count? If all the warrantedoptions, et cetera were converted to common shares, what is the fully dilutedshare count currently?

[Lawrence A. Kenyon:]

67 million shares, Ray.

[Raymond A. Myers -Emerging Growth Equities:]

Great. Thanks, Larry. I’ll let othersask questions.

[Operator:]

(Operator Instructions) There are nofurther questions at this time. I would like to hand the floor back over to Mr.Kenyon for any closing comments.

[Lawrence A. Kenyon:]

Thank you and thank you, everyone, onceagain for participating in this inaugural quarterly update conference call. Aswe mentioned before, we intend to conduct these calls in the future on aregular basis and we hope that you will find them useful. I will now turn thecall over to Tina for her final remarks.

[Tina Shogen:]

Thank you, Larry. Everyone at Alfacellis excited by the opportunity that awaits us in 2008. Key events over the next12 months include

[Operator:]

This concludes today’s teleconference.You may disconnect your lines at this time. Thank you for your participation.