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8-K - FORM 8-K - ALBIREO PHARMA, INC. | y88254e8vk.htm |
Exhibit 99.1
Biodel Reports Fourth Quarter and Fiscal Year 2010 Financial Results
Conference Call Today at 4:30 PM EDT
DANBURY, Conn., Dec 9, 2010 Biodel Inc. (Nasdaq: BIOD) today reported financial results for the
fourth quarter and fiscal year ended September 30, 2010.
Fourth Quarter and Fiscal Year 2010 Financial Results
Biodel reported a net loss for the quarter ended September 30, 2010 of $8.1 million, or $0.31 per
share, compared to a net loss of $10.5 million, or $0.44 per share, for the quarter ended September
30, 2009.
Net loss applicable to common stockholders for the fiscal year ended September 30, 2010 was $38.3
million, or $1.58 per share, compared to $43.3 million, or $1.82 per share, for the fiscal year
ended September 30, 2009.
Research and development expenses were $4.5 million for the quarter ended September 30, 2010,
compared to $7.9 million for the same period in the prior year. For the fiscal year ended
September 30, 2010, research and development expenses were $26.2 million, compared to $32.3 million
for the fiscal year ended September 30, 2009. The decrease in research and development expenses
was primarily due to reductions in clinical, manufacturing, device development and personnel
expenses and was partially offset by increases in regulatory expenses associated with the
submission of the new drug application (NDA) for Linjeta.
General and administrative expenses totaled $2.4 million for the quarter ended September 30, 2010,
compared to $2.6 million for the same period in the prior year. General and administrative expenses
totaled $11.0 million for the year ended September 30, 2010, compared to $11.0 million for the
fiscal year ended September 30, 2009.
Expenses for the fiscal year ended September 30, 2010 and 2009 include $5.6 and $5.1 million in
stock-based compensation expense related to options granted to employees and non-employees.
Biodel did not recognize any revenue during the fiscal years ended September 30, 2010 or 2009.
At September 30, 2010, Biodel had cash, cash equivalents, restricted cash and marketable securities
of $29.1 million and 26.4 million shares of common stock outstanding.
Business Review
Since receiving a complete response letter from the U.S. Food and Drug Administration (FDA) in
October regarding the NDA for Linjeta, Biodel has requested a meeting with FDA staff to review the
agencys request for new information about the drug. Biodel plans to meet with the FDA to discuss
the agencys comments in the letter and to determine how to satisfy its requests for additional
information regarding the efficacy, safety and manufacture of Linjeta.
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Biodel does not anticipate commencing new pivotal Phase 3 clinical trials with its current
formulation of Linjeta prior to determining whether one of its other proprietary rapid-acting
insulin or insulin analog formulations should be advanced in its place. These alternate
formulations generally use the same or similar excipients as Linjeta, but may present improvements
with regard to injection site discomfort. In fiscal year 2011, Biodel intends to conduct
preclinical studies and Phase 1 clinical trials to determine whether one or more of its newer
insulin formulations is likely to offer a combination of pharmacokinetic, stability and
tolerability characteristics that is preferable to Linjeta. Following its meeting with the FDA
regarding Linjeta and based on its analysis of the preclinical and Phase 1 clinical data for its
alternate formulations, Biodel will determine the number, type and duration of additional trials it
will conduct prior to initiating Phase 3 clinical trials with a proprietary rapid-acting insulin.
In November at the Diabetes Technology Meeting in Bethesda, Maryland, the company reported results
of a study comparing the pharmacokinetic characteristics and toleration of Linjeta to two modified
formulations of the drug that were associated with improved injection site tolerability. At the
same conference, Biodel also reported results from the extended release insulin glargine,
glucose-sensing basal insulin and stabilized glucagon development programs in which new
formulations of these compounds demonstrated improved target-product profiles compared to their
unmodified forms. At this time, Biodel plans to focus its resources on developing new formulations
of Linjeta or other proprietary rapid-acting insulin formulations, while conducting limited
preclinical testing on its other product candidates.
Biodel will present a corporate update to investors in January 2011 at the 29th Annual
J.P. Morgan Healthcare Conference in San Francisco. Details regarding that presentation will be
announced prior to the event.
Conference Call and Webcast Information
Biodels senior management will host a conference call on December 9, 2010, beginning at 4:30 pm
Eastern Standard Time, to discuss these results and provide a company update. Live audio of the
conference call will be available to investors, members of the news media and the general public by
dialing 1-877-303-8028 (United States) or 1-760-536-5167 (international). To access the call by
live audio webcast, please log on to the investor section of the companys website at
www.biodel.com. An archived version of the audio webcast will be available at Biodels website.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and
commercialization of innovative treatments for diabetes that may be safer, more effective and more
convenient for patients. We develop our product candidates by applying our proprietary formulation
technologies to existing drugs in order to improve their therapeutic profiles. For further
information regarding Biodel, please visit the companys website at www.biodel.com.
Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements include statements about future
activities related to the complete response letter regarding the companys new drug application for
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Linjeta; the companys response to the complete response letter; the importance of the complete
response letter; and the companys focus, goals, strategy, research and development programs, and
ability to develop and commercialize product candidates. Forward-looking statements represent our
managements judgment regarding future events. All statements, other than statements of historical
facts, including statements regarding our strategy, future operations, future clinical trial
results, future financial position, future revenues, projected costs, prospects, plans and
objectives of management are forward-looking statements. The words anticipates, believes,
could, estimates, expects, intends, may, plans, potential, predicts, projects,
should, will, would and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words. The
companys forward-looking statements are subject to a number of known and unknown risks and
uncertainties that could cause actual results, performance or achievements to differ materially
from those described or implied in the forward-looking statements, including, but not limited to,
our ability to respond to the complete response letter regarding our new drug application for
Linjeta in a timely manner and the possibility that information we provide in response to the
letter may not be sufficient for the approval of Linjeta or another rapid-acting insulin or
insulin analog by the FDA; our ability to secure FDA approval for Linjeta and our other product
candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, and the degree to
which we are able to clarify with the FDA related regulatory requirements; our ability to conduct
the additional pivotal clinical trials the FDA requested in the complete response letter or other
tests or analyses required by the FDA to secure approval to commercialize Linjeta; our ability to
develop and commercialize formulations of Linjeta or other rapid-acting insulin or insulin analog
formulations that may be associated with less injection site discomfort than the formulation that
is the subject of the complete response letter we received from the FDA; the progress, timing or
success of our product candidates, particularly Linjeta, and that of our research, development and
clinical programs, including any resulting data analyses; our ability to enter into collaboration
arrangements for the commercialization of our product candidates and the success or failure of any
such collaborations into which we enter, or our ability to commercialize our product candidates
ourselves; our ability to enforce our patent for Linjeta and our ability to secure additional
patents for Linjeta and for our other product candidates; our ability to protect our intellectual
property and operate our business without infringing upon the intellectual property rights of
others and the degree of clinical utility of our products; the ability of our major suppliers,
including suppliers of insulin, to produce our product or products in our final dosage form; our
commercialization, marketing and manufacturing capabilities and strategies; our ability to
accurately estimate anticipated operating losses, future revenues, capital requirements and our
needs for additional financing; and other factors identified in our most recent quarterly report on
Form 10-Q for the quarter ended June 30, 2010. The company disclaims any obligation to update any
forward-looking statements as a result of events occurring after the date of this press release.
BIOD-G
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Biodel Inc.
(A Development Stage Company)
(A Development Stage Company)
Balance Sheets
(In thousands, except share and per share amounts)
(In thousands, except share and per share amounts)
September 30, | ||||||||
2009 | 2010 | |||||||
ASSETS |
||||||||
Current: |
||||||||
Cash and cash equivalents |
$ | 54,640 | $ | 22,922 | ||||
Restricted cash |
| 150 | ||||||
Marketable securities, available for sale |
| 6,001 | ||||||
Taxes receivable |
752 | 116 | ||||||
Other receivable |
| 11 | ||||||
Prepaid and other assets |
482 | 365 | ||||||
Total current assets |
55,874 | 29,565 | ||||||
Property and equipment, net |
3,695 | 2,998 | ||||||
Intellectual property, net |
56 | 53 | ||||||
Total assets |
$ | 59,625 | $ | 32,616 | ||||
Current: |
||||||||
Accounts payable |
$ | 1,007 | $ | 1,989 | ||||
Accrued expenses: |
||||||||
Clinical trial expenses |
5,647 | 1,362 | ||||||
Payroll and related |
1,117 | 357 | ||||||
Accounting and legal fees |
325 | 300 | ||||||
Severance |
183 | | ||||||
Other |
643 | 334 | ||||||
Income taxes payable |
165 | 45 | ||||||
Total current liabilities |
9,087 | 4,387 | ||||||
Common stock warrant liability |
| 4,169 | ||||||
Total long term liabilities |
| 4,169 | ||||||
Commitments |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value; 50,000,000 shares authorized, none outstanding |
| | ||||||
Common stock, $.01 par value; 100,000,000 shares authorized; 23,803,672 and
26,399,764 issued and outstanding |
238 | 264 | ||||||
Additional paid-in capital |
176,764 | 188,549 | ||||||
Accumulated other comprehensive loss |
| 1 | ||||||
Deficit accumulated during the development stage |
(126,464 | ) | (164,754 | ) | ||||
Total stockholders equity |
50,538 | 24,060 | ||||||
Total liabilities and stockholders equity |
$ | 59,625 | $ | 32,616 | ||||
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Biodel Inc.
(A Development Stage Company)
(A Development Stage Company)
Statements of Operations
(In thousands, except share and per share amounts)
(In thousands, except share and per share amounts)
December 3, | ||||||||||||||||
2003 | ||||||||||||||||
(Inception) to | ||||||||||||||||
Year Ended September 30, | September 30, | |||||||||||||||
2008 | 2009 | 2010 | 2010 | |||||||||||||
Revenue |
$ | | $ | | $ | | $ | | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
32,554 | 32,325 | 26,177 | 116,228 | ||||||||||||
General and administrative |
14,800 | 10,994 | 10,980 | 47,625 | ||||||||||||
Total operating expenses |
47,354 | 43,319 | 37,157 | 163,853 | ||||||||||||
Other (income) and expense: |
||||||||||||||||
Interest and other income |
(3,010 | ) | (386 | ) | (17 | ) | (5,506 | ) | ||||||||
Interest expense |
| | | 78 | ||||||||||||
Adjustments to fair value of common stock
warrant liability |
| | 1,254 | 1,254 | ||||||||||||
Loss on settlement of debt |
| | | 627 | ||||||||||||
Operating loss before tax provision (benefit) |
(44,344 | ) | (42,933 | ) | (38,394 | ) | (160,306 | ) | ||||||||
Tax provision (benefit) |
(983 | ) | 337 | (104 | ) | (612 | ) | |||||||||
Net loss |
(43,361 | ) | (43,270 | ) | (38,290 | ) | (159,694 | ) | ||||||||
Charge for accretion of beneficial conversion rights |
| | | (603 | ) | |||||||||||
Deemed dividend warrants |
| | | (4,457 | ) | |||||||||||
Net loss applicable to common stockholders |
$ | (43,361 | ) | $ | (43,270 | ) | $ | (38,290 | ) | $ | (164,754 | ) | ||||
Net loss per share basic and diluted |
$ | (1.94 | ) | $ | (1.82 | ) | $ | (1.58 | ) | |||||||
Weighted average shares outstanding basic and
diluted |
22,390,434 | 23,746,598 | 24,161,866 | |||||||||||||
The Trout Group LLC
Seth D. Lewis, +1-646-378-2952
Seth D. Lewis, +1-646-378-2952
SOURCE Biodel Inc.
Copyright (C) 2010 PR Newswire. All rights reserved
Copyright (C) 2010 PR Newswire. All rights reserved
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