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8-K - FORM 8-K - ALBIREO PHARMA, INC. | y92270e8vk.htm |
Exhibit 99.1
BIODEL REPORTS THIRD QUARTER FISCAL YEAR 2011 FINANCIAL RESULTS
Company to Provide Update on Phase 1 Program on Conference Call Today at 4:30pm EDT
DANBURY, Conn., Aug 04, 2011 /PRNewswire via COMTEX News Network/ Biodel Inc. (Nasdaq: BIOD)
today reported financial results for the third quarter ended June 30, 2011.
Third Quarter Operating Highlights
During Biodels third quarter of fiscal year 2011, the company:
| completed Phase 1 testing of two new ultra-rapid-acting formulations of recombinant human insulin, or RHI, for subcutaneous injection; |
| supported investigators at Oregon Health and Sciences University who have initiated a Phase 1 study evaluating these formulations for insulin pump administration; |
| selected multiple analog-based candidate formulations for possible clinical development; and |
| extended the cash runway by reducing near-term RHI purchase requirements and raising approximately $30 million in new capital. |
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: We are continuing to
develop and evaluate ultra-rapid-acting human insulin and insulin analog formulations and are
making good progress in assessing tolerability and activity in a variety of pre-clinical and
clinical settings. We plan to provide details on the pharmacokinetic, pharmacodynamic and
injection site tolerability characteristics of the two RHI-based ultra-rapid-acting formulations
from the recently completed subcutaneous injection Phase 1 trial and will update the timelines for
completion of the insulin pump trial. In addition, we have taken a number of steps to extend our
cash runway including renegotiation of our RHI supply agreement and raising additional capital from
previous and new investors. These initiatives are helping us create a new generation of
ultra-rapid-acting insulin product candidates and sustainable long-term value for all
shareholders.
Third Quarter Financial Results
Biodel reported a net loss of $4.0 million, or $0.12 per share, for the quarter ended June 30, 2011
compared to a net loss of $8.6 million, or $0.36 per share, for the third quarter of fiscal year
2010.
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Research and development expenses were $2.9 million for the three months ended June 30, 2011,
compared to $5.9 million for the same period in the prior year. The decrease in research and
development expenses was primarily attributed to reductions in clinical and regulatory expenses.
General and administrative expenses totaled $2.4 million for the three months ended June 30, 2011,
compared to $2.8 million for the same period in the prior year.
Expenses for the quarter ended June 30, 2010 and 2011 include $1.5 million and $1.3 million,
respectively, in stock-based compensation expense related to options granted to employees and
non-employees.
Biodel did not recognize any revenue during the quarter ended June 30, 2010 or 2011.
At June 30, 2011, Biodel had cash, cash equivalents and marketable securities of $42 million and
38.6 million shares outstanding.
Conference Call and Webcast Information
Biodels senior management will host a conference call on August 4, 2011 beginning at 4:30 pm
Eastern Daylight 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 on 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 clinical development plans for the companys drug candidates, including
the potential timing, design and outcomes of clinical trials; and the companys 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,
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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 accepted 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; our ability to market, commercialize and
achieve market acceptance for product candidates developed using our VIAdel technology; the
progress or success of our research, development and clinical programs and the initiation and
completion of our clinical trials; the possibility that patients taking Linjeta may experience
more injection site discomfort than they experience with competing products; unexpected data that
may result from our clinical trials and our research and development activities; our ability to
protect our intellectual property and operate our business without infringing upon the intellectual
property rights of others; our estimates of future performance; our ability to enter into
collaboration arrangements for the commercialization of our product candidates and the success or
failure of those collaborations after consummation, if consummated; the rate and degree of market
acceptance and clinical utility of our products; our commercialization, marketing and manufacturing
capabilities and strategy; our estimates regarding anticipated operating losses, future revenues,
capital requirements and our needs for additional financing; and other factors identified in our
most recent report on Form 10-Q for the quarter ended March 31, 2011. The company disclaims any
obligation to update any forward-looking statements as a result of events occurring after the date
of this press release.
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Biodel Inc.
(A Development Stage Company)
Condensed Balance Sheets
(in thousands, except share and per share amounts)
(A Development Stage Company)
Condensed Balance Sheets
(in thousands, except share and per share amounts)
September 30, | June 30, | |||||||
2010 | 2011 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Current: |
||||||||
Cash and cash equivalents |
$ | 22,922 | $ | 41,999 | ||||
Restricted cash |
150 | 60 | ||||||
Marketable securities, available for sale |
6,001 | | ||||||
Taxes receivable |
116 | 86 | ||||||
Other receivables |
11 | 9 | ||||||
Prepaid and other assets |
365 | 497 | ||||||
Total current assets |
29,565 | 42,651 | ||||||
Property and equipment, net |
2,998 | 2,432 | ||||||
Intellectual property, net |
53 | 50 | ||||||
Other assets |
| 9 | ||||||
Total assets |
$ | 32,616 | $ | 45,142 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current: |
||||||||
Accounts payable |
$ | 1,989 | $ | 102 | ||||
Accrued expenses: |
||||||||
Clinical trial expenses |
1,362 | 974 | ||||||
Payroll and related |
357 | 954 | ||||||
Accounting and legal fees |
300 | 228 | ||||||
Severance |
| 686 | ||||||
Other |
334 | 241 | ||||||
Income taxes payable |
45 | 47 | ||||||
Total current liabilities |
4,387 | 3,232 | ||||||
Common stock warrant liability |
4,169 | 9,717 | ||||||
Other long term liabilities |
| 313 | ||||||
Total liabilities |
$ | 8,556 | $ | 13,262 | ||||
Commitments
Stockholders equity: |
||||||||
Series A preferred stock, $.01 par value; 50,000,000 shares authorized; 0 and 1,813,944 outstanding |
| 18 | ||||||
Common stock, $.01 par value; 100,000,000 shares authorized; 26,399,764 and 38,605,483 issued and
outstanding |
264 | 386 | ||||||
Additional paid-in capital |
188,549 | 210,955 | ||||||
Accumulated other comprehensive income |
1 | | ||||||
Deficit accumulated during the development stage |
(164,754 | ) | (179,479 | ) | ||||
Total stockholders equity |
24,060 | 31,880 | ||||||
Total liabilities and stockholders equity |
$ | 32,616 | $ | 45,142 | ||||
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Biodel Inc.
(A Development Stage Company)
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
(A Development Stage Company)
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
December 3, | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | 2003 | ||||||||||||||||||
June 30, | June 30, | (inception) to | ||||||||||||||||||
June 30, | ||||||||||||||||||||
2010 | 2011 | 2010 | 2011 | 2011 | ||||||||||||||||
Revenue |
$ | | $ | | $ | | $ | | $ | | ||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
5,890 | 2,941 | 21,658 | 11,349 | 127,577 | |||||||||||||||
General and administrative |
2,780 | 2,382 | 8,573 | 7,264 | 54,889 | |||||||||||||||
Total operating expenses |
8,670 | 5,323 | 30,231 | 18,613 | 182,466 | |||||||||||||||
Other (income) and expense: |
||||||||||||||||||||
Interest and other income |
(3 | ) | (20 | ) | (10 | ) | (30 | ) | (5,536 | ) | ||||||||||
Interest expense |
| | | | 78 | |||||||||||||||
Adjustment to fair value
of common stock warrant
liability |
| (1,355 | ) | | (3,890 | ) | (2,636 | ) | ||||||||||||
Loss on settlement of debt |
| | | | 627 | |||||||||||||||
Operating loss before tax
provision (benefit) |
(8,667 | ) | (3,948 | ) | (30,221 | ) | (14,693 | ) | (174,999 | ) | ||||||||||
Tax provision (benefit) |
(38 | ) | 26 | (35 | ) | 32 | (580 | ) | ||||||||||||
Net loss |
(8,629 | ) | (3,974 | ) | (30,186 | ) | (14,725 | ) | (174,419 | ) | ||||||||||
Charge for accretion of
beneficial conversion rights |
| | | | (603 | ) | ||||||||||||||
Deemed dividend warrants |
| | | | (4,457 | ) | ||||||||||||||
Net loss applicable to common
stockholders |
$ | (8,629 | ) | $ | (3,974 | ) | $ | (30,186 | ) | $ | (14,725 | ) | $ | (179,479 | ) | |||||
Net loss per share basic
and diluted |
$ | (0.36 | ) | $ | (0.12 | ) | $ | (1.26 | ) | $ | (0.51 | ) | ||||||||
Weighted average shares
outstanding basic and
diluted |
23,944,386 | 33,017,859 | 23,892,899 | 28,635,431 | ||||||||||||||||
BIOD-G
CONTACT: Seth D. Lewis, +1-646-378-2952
SOURCE: Biodel Inc.
News provided by Acquire Media
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