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8-K - FORM 8-K - VION PHARMACEUTICALS INC | y02570e8vk.htm |
EX-99.1 - EX-99.1 - VION PHARMACEUTICALS INC | y02570exv99w1.htm |
Exhibit 99.2
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© 2009 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
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Final Transcript
Nov 12, 2009 / 01:30PM GMT, VION Q3 2009 Vion Pharmaceuticals Earnings Conference Call
CORPORATE PARTICIPANTS
Howard Johnson
Vion Pharmaceuticals, Inc. President, CFO
Vion Pharmaceuticals, Inc. President, CFO
Ann Cahill
Vion Pharmaceuticals, Inc. VP Clinical Development
Vion Pharmaceuticals, Inc. VP Clinical Development
Alan Kessman
Vion Pharmaceuticals, Inc. CEO
Vion Pharmaceuticals, Inc. CEO
CONFERENCE CALL PARTICIPANTS
Leah Hartman
CRT Capital Group Analyst
CRT Capital Group Analyst
PRESENTATION
Operator
Good day, ladies and gentlemen, and welcome to the third-quarter 2009 Vion Pharmaceuticals
conference call. My name is [Shaquana] and I will be your coordinator for today.
And this time, all participants are in a listen-only mode. We will facilitate a question-and-answer
session towards the end of this conference. (Operator Instructions)
I would now like to turn the presentation over to your host for todays call, Mr. Howard Johnson,
President and Chief Financial Officer. Please proceed, sir.
Howard Johnson Vion Pharmaceuticals, Inc. President, CFO
Thank you, operator. Good morning.
This conference call will contain forward-looking statements. Such statements are subject to
certain risk factors which may cause Vions plans to differ or results to vary from those expected,
including Vion being unsuccessful in achieving its strategic alternatives, including any
combination of a restructuring of the Company and its debt, a sale of the Company or its assets,
and raising new capital, in which case it may have to curtail or cease operations, liquidate its
assets, and/or file for bankruptcy; Vions potential inability to obtain regulatory approval for
its products, particularly Onrigin (laromustine) injection; delays in the regulatory approval
process, particularly for Onrigin; delays or unfavorable results of drug trials; the possibility
that favorable results of earlier preclinical studies, clinical trials or interim clinical trials
are not confirmed by safety and efficacy results in later or final clinical trials; the need for
additional research and testing, including the need for a new randomized trial of Onrigin prior to
regulatory approval in accordance with the recommendation of the Oncologic Drugs Advisory
Committee; the inability to manufacture product; the potential inability to secure external sources
of funding to continue operations; the inability to access capital and funding on favorable terms;
continued operating losses, and the inability to continue operations as a result; and a variety of
other risks set forth from time to time in Vions filings with the Securities and Exchange
Commission, including but not limited to the risks attendant to the forward-looking statements
included under Item 1A Risk Factors in Vions Form 10-K for the year ended December 31, 2008 and
Vions Form 10-Q for the quarter ended September 30, 2009.
Except in special circumstances in which a duty to update arises under law when prior disclosure
becomes materially misleading in light of subsequent events, Vion does not intend to update any of
these forward-looking statements to reflect events or circumstances after the date hereof, or to
reflect the occurrence of unanticipated events.
Now, Id like to turn the conference call over to Alan Kessman, Chief Executive Officer of Vion
Pharmaceuticals.
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Final Transcript
Nov 12, 2009 / 01:30PM GMT, VION Q3 2009 Vion Pharmaceuticals Earnings Conference Call
Alan Kessman Vion Pharmaceuticals, Inc. CEO
Thank you, Howard. Good morning, everyone. We thank you for joining us on this conference
call.
With me today is Howard Johnson, our President and CFO; Ann Cahill, our Vice President-Clinical
Affairs; Tanya Lewis, our Vice President-Regulatory Affairs; Bill Hahne, our Vice President
Medical; and Karen Schmedlin, our VP-Finance.
Before Howard takes you through the quarterly results, I wanted to update everyone on the Companys
activities during the third quarter.
As most of you know, in February of this year, we filed a New Drug Application for Onrigin with the
US Food and Drug Administration as a single-agent in elderly patients with de novo poor-risk acute
myeloid leukemia. In April, we announced that the NDA or the New Drug Application for Onrigin had
been accepted for standard review by the FDA with a user fee goal date of December 12, 2009 for a
decision on approval.
We made a presentation to the Oncologic Drugs Advisory Committee, commonly referred to as ODAC, of
the FDA on September 1. At that meeting, the ODAC voted to require that a randomized study defining
the efficacy and safety of Onrigin be completed prior to a regulatory approval of Onrigin.
We are working on submitting a Special Protocol Assessment, commonly referred to as an SPA, to the
FDA in 2009 for a randomized trial of Onrigin. We expect to hear from the FDA about the status of
our NDA before our end user fee date of December 12, 2009, but at this time, we have received no
formal communication.
We continue to support four ongoing, investigator-initiated clinical trials of Onrigin, three in
AML. Our Phase III trial with the Dutch cooperative group HOVON has now accrued over 100 patients.
This trial is evaluating Onrigin plus the standard AML regimen of ara-C, an anthracycline, or 7+3,
in front-line adult AML patients.
We also have a Phase I/II trial of Onrigin in combination with 7+3 in adult patients with
unfavorable cytogenetics, and a Phase I trial of Onrigin plus ara-C in elderly AML patients.
Initial data from these trials were presented at ASCO in June. The conclusions from the poster
presentation were that Onrigin could be combined with ara-C in this patient population in doses up
to 500 mg per meter squared with evidence of efficacy and tolerability. Our final ongoing Phase
I/II trial of Onrigin is in a solid tumor application for adult brain tumors at Northwestern.
Onrigin is being combined with temozolomide in this setting.
In October, we announced that we had hired an investment bank to assist in evaluating our strategic
alternatives. These alternatives include any combination of a restructuring of the Company and its
debt and/or a sale of the Company and/or its assets. We may also consider financing options.
We expect our strategic review to be completed in the fourth quarter of 2009. The outcome of our
strategic review will determine whether we continue operations or whether we curtail or cease
operations, liquidate our assets and/or file for bankruptcy.
We ended the third quarter of 2009 to with cash and cash equivalents totaling $18.9 million. Our
review of our strategic alternatives will determine our future operations, if any, and levels of
cash expenditures and employee staffing. It is likely that, without additional financing, our cash
and cash equivalents will not be adequate to fund our operations for the next 12 months.
Because of our financial status and the ongoing strategic review, we can offer no assurances at
this time about our ability to raise additional capital to fund a new randomized trial of Onrigin.
We will report back to you as to our direction when the strategic review is completed this quarter.
Now, I will ask Howard to present the financial results to you.
Howard Johnson Vion Pharmaceuticals, Inc. President, CFO
Thank you, Alan.
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Final Transcript
Nov 12, 2009 / 01:30PM GMT, VION Q3 2009 Vion Pharmaceuticals Earnings Conference Call
In the third quarter of 2009, we reported a net loss of $6.2 million, or $0.78 per share, based on
8 million weighted shares outstanding. This compares to a net loss of $6.8 million in the third
quarter of 2008, or $0.92 per share, based on 7.4 million weighted average shares outstanding.
In the quarter, operating expenses declined by $1 million, compared to last year, from $5.5 million
last year to $4.5 million this year. The decline in operating expenses included a decrease in
clinical trials expense of $528,000, offset by an increase of $284,000 in other Research and
Development expense.
Our clinical trials expense declined due to reduced expense in Onrigin clinical trials sponsored by
us, offset by the additional expense of our HOVON trial. Other Research and Development expense
increased as we prepared for the ODAC meeting and continued to interact with the FDA on our NDA
filing.
Lower stock-based compensation and incentive compensation expense were also contributing factors to
the change in clinical and other R&D expense.
Marketing G&A expense declined by $793,000, due primarily to lower stock-based compensation and
incentive compensation expense.
As a whole, non-cash stock-based compensation expense was $12,000 in the quarter, compared to
$326,000 last year.
Interest expense for our convertible senior notes was $1.7 million in the third quarter of 2009 as
compared to $1.5 million for the same 2008 quarter. Interest income declined by $223,000 in 2009,
based on lower interest rates and lower invested balances.
For the nine-month period in 2009, we reported a net loss of $17.1 million, or $2.15 per share,
based on 8 million weighted average shares outstanding. This compared to a net loss of $22.9
million in the same period last year, or $3.12 per share, based on 7.4 million weighted average
shares outstanding.
In the nine-month period, operating expenses declined by $5.3 million, compared to last year, from
$19.4 million last year to $14 million this year. The expense decline was a result of lower
clinical trials expense of $3.7 million as well as lower other Research and Development expense of
$472,000. Our clinical trials expense declined due to reduced expense in Onrigin clinical trials
sponsored by us, offset by the additional expense of our HOVON trial. Other R&D expense decreased
primarily due to lower stock-based compensation expense and lower incentive compensation, offset by
increased regulatory expenses as we prepare for the ODAC meeting and continue to interact with the
FDA on our NDA filing.
Lower stock-based compensation expense and lower incentive compensation were also factors in the
decline of clinical expense.
Marketing, General and Administrative expenses declined by $1.132 million, also due to lower
incentive comp expense and stock-based comp expense.
As a whole, our non-cash stock-based compensation expenses were $122,000 in the nine-month period
in 2009, compared to $2 million last year.
Interest expense for our convertible senior notes was $5.7 million in the nine-month period,
compared to $4.5 million in the same 2008 period. Interest expense in 2009 included $807,000 of
additional non-cash amortization expense recorded in the first quarter to reflect the cumulative
amortization of an embedded derivative in our senior notes that was disclosed in the first quarter
of the year.
Interest income declined by $980,000 based on lower interest rates and lower invested balances. The
nine-month numbers also include other income of $2.6 million to reflect the change in the fair
value of the embedded derivative just mentioned.
We ended the quarter with $18.9 million in cash. As Alan mentioned, this cash position is not
likely to fund the Companys operations for the next 12 months and does not include funding for a
randomized trial of Onrigin. Therefore, as we have disclosed, we have hired an investment bank to
assist us in evaluating our strategic options. The outcome of this strategic review will determine
whether we continue operations or whether we curtail or cease operations, liquidate our assets,
and/or file for bankruptcy.
Thank you for listening today. We are now ready to take your questions.
QUESTION AND ANSWER
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Final Transcript
Nov 12, 2009 / 01:30PM GMT, VION Q3 2009 Vion Pharmaceuticals Earnings Conference Call
Operator
(Operator Instructions). Leah Hartman, CRT Capital.
Leah Hartman CRT Capital Group Analyst
Good morning, gentlemen, and hi, Ann.
I just wanted to I guess two questions. One is an update on Triapine, and two is any commentary,
if you can, with respect to monthly cash burn over this quarter and into the first quarter of next
year.
Alan Kessman Vion Pharmaceuticals, Inc. CEO
Ann, do you want to take Triapine?
Ann Cahill Vion Pharmaceuticals, Inc. VP Clinical Development
Sure. I will start with the Triapine question. Good morning.
Triapine has been largely developed through the NCI agreement trials. Those trials continue to come
forward through publication planning, mostly in the Phase I and Phase II setting, without a clear
solid tumor development path at this point and is not really the focus of our clinical development
plan right now.
I have also fielded a number of investigator requests and interest in looking at Triapine in
hematologic malignancies, but we have not gone forward with those at this point.
Leah Hartman CRT Capital Group Analyst
Okay, I was just looking for if there continued to be outside interest in the program
(multiple speakers).
Ann Cahill Vion Pharmaceuticals, Inc. VP Clinical Development
Absolutely.
Leah Hartman CRT Capital Group Analyst
Yes, okay. Thank you, Ann.
Alan Kessman Vion Pharmaceuticals, Inc. CEO
As far as the cash burn goes, Leah, we have not disclosed publicly any specifics but I can
tell you that we are looking at all of the alternatives that we possibly can to reduce cash burn. I
dont expect that there will be significant cash reduction in the burn in Q4 of this year, but we
are looking at what could be potentially more meaningful reductions as we head into 2010 as some of
the things we put into place in Q4 take effect in the first quarter of 2010.
Leah Hartman CRT Capital Group Analyst
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Final Transcript
Nov 12, 2009 / 01:30PM GMT, VION Q3 2009 Vion Pharmaceuticals Earnings Conference Call
Okay. Well, good luck to all of you during the review.
Alan Kessman Vion Pharmaceuticals, Inc. CEO
Thank you.
Operator
(Operator Instructions). At this time, there are no further audio questions.
Alan Kessman Vion Pharmaceuticals, Inc. CEO
Thank you, operator. We thank you for listening today. We assure you that, as areas develop
and we have information that needs to be made public, we will give it to you as soon as we possibly
can. Thank you. Good-bye.
Operator
Thank you for your participation in todays conference. This concludes the presentation. You
may now disconnect, and have a great day.
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