DANBURY, Conn., Dec. 11 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today reported fourth quarter and fiscal year ended September 30, 2007 financial results, updated pipeline progress and disclosed 2008 objectives.
"In 2007, our first year as a public company, we advanced our pipeline and achieved critical corporate objectives," stated Dr. Solomon Steiner, CEO and Chairman of Biodel. "The significant milestones reached include our successful initial public offering, the issuance of Patent No. 7,279,457 encompassing VIAject(TM) and VIAtab(TM), the expansion of the pivotal VIAject(TM) trials into Europe and Asia, and the presentation of additional positive clinical data from our VIAject(TM) program. We look forward to completing the Phase III VIAject(TM) clinical trials and expect to file a New Drug Application for VIAject(TM) by calendar year end 2008."
Fourth Quarter and Full Year Financial Results
Biodel reported a net loss for the fourth quarter ended September 30, 2007 of $8.4 million, or $0.42 per share, as compared to a net loss of $3.9 million, or $0.36 per share, for the comparable period in the prior year. The fourth quarter 2007 net loss includes $0.6 million of non-cash stock-based compensation expenses.
Net loss applicable to common stockholders for the year ended September 30, 2007 was $27.0 million, or $1.76 per share, as compared to $8.7 million, or $1.05 per share for the year ended September 30, 2006. The net loss includes non-cash charges of $4.2 million, or $0.21 per share, of stock-based compensation and $4.5 million, or $0.22 per share from a deemed dividend charge related to the exercise of warrants at a discounted exercise price.
Biodel reported no revenue during the three months and years ended September 30, 2007 and September 30, 2006.
Research and development expenses were $7.1 million for the three months ended September 30, 2007, compared to $2.3 million for the same period in the prior year. For the 2007 fiscal year, research and development expenses were $15.9 million, compared to $6.0 million for 2006. Both the increase in quarterly and annual expenses were primarily due to costs related to Biodel's two continuing pivotal Phase III clinical trials for VIAject(TM) and personnel-related expenses. To support the research and development projects and clinical trials, Biodel increased the research and development and clinical staff from eight, in fiscal year 2006, to eighteen. Currently, there are twenty-four research and development and clinical staff.
General and administrative expenses totaled $2.3 million for the three months ended September 30, 2007, compared to $0.6 million for the same period in the prior year. General and administrative expenses totaled $8.4 million for the year ended September 30, 2007, compared to $1.5 million for the comparable period in the prior year. The increase for both the quarter and full year expenses was primarily attributable to $1.0 million and $5.9 million, respectively, in personnel-related expense, including non-cash stock- based compensation expense and performance-based bonus accruals. The non-cash expense for the fiscal year included a $1.7 million charge for options granted to the Board of Directors in May 2007 that vested immediately. The balance of the increase was due to increases in accounting, legal and consulting fees associated with the preparation to become and operate as a public company.
In fiscal year 2007, Biodel increased its general and administrative personnel from eight to twelve. This was associated with the preparation to become and operate as a publicly traded company and further support research and development and clinical projects. Currently, there are seventeen general and administrative personnel.
At the end of fiscal year 2007, Biodel had cash and cash equivalents of $80.0 million and 20.2 million shares outstanding.
Fiscal Year 2007 Corporate & Clinical Highlights
The Company reported progress in advancing the clinical development of
its lead product candidates and success in executing its corporate goals:
* Filed an investigational new drug ("IND") application, amended an
existing IND, and initiated pharmacokinetics and pharmacodynamics trials
to develop a suite of six VIAject(TM) products for commercialization:
VIAject(TM) A: Single Vial 10ml (liquid; refrigerated or frozen)
-- 100 IU/ml
-- 25 IU/ml
VIAject(TM) B: Twin Vials 10ml (lyophilized cake and diluent; no
-- 100 IU/ml
-- 25 IU/ml
Pen Cartridge Systems 3ml
-- 100 IU/ml (1 IU increments)
-- 25 IU/ml (1/4 IU increments)
* Presented positive clinical data from the VIAject(TM) program:
* At the annual meeting of the American Diabetes Association, the
Company presented additional interim results from its Phase III
clinical trials for VIAject(TM) that demonstrated statistically
significant daily meal-time dose reductions in patients with Type
1 and Type 2 diabetes using VIAject(TM), significantly fewer mild
and moderate hypoglycemic events and reduction in weight gain.
* At the annual meeting of the European Association for the Study of
Diabetes, the Company presented VIAject(TM) Phase II meal study
data that demonstrated statistically significant and clinically
relevant improved glycemic control compared to regular human
insulin (Humulin(R) R) and lispro (Humalog(R)).
* At the annual Diabetes Technology Meeting, after the close of
fiscal year 2007, the Company presented the results of a meal
study comparing VIAject(TM) head-to-head with Humalog(R) in
patients who regularly use Humalog(R) as their prandial insulin.
VIAject(TM) produced significantly superior glycemic control,
reduced the risk of hypoglycemia, and reduced glycemic excursions
compared to Humalog(R).
* Expanded the Company's two ongoing pivotal Phase III clinical trials
of VIAject(TM) into Europe and Asia.
* The United States Patent and Trademark Office issued Patent No.
7,279,457 encompassing VIAject(TM) and VIAtab(TM).
* Completed the Company's initial public offering of 5,750,000 shares of
its common stock at a price to the public of $15.00 per share. Net
proceeds from the offering, after underwriting discounts, commissions
and expenses, totaled approximately $78.8 million (net).
Calendar Year 2008 Corporate Goals
The company provided details regarding critical 2008 calendar year
* Complete enrollment of the two pivotal Phase III clinical trials of
VIAject(TM) for Type 1 and Type 2 diabetic patients.
* Complete the pharmacokinetics and pharmacodynamics trials of the suite
of six VIAject(TM) products.
* Announce data from the two completed pivotal Phase III clinical trials
of VIAject(TM). (The Company will not present any additional interim
data prior to the completion of both Phase III trials.)
* File a New Drug Application for VIAject(TM).
* Finalize commercialization strategy for VIAject(TM).
Conference Call and Webcast Information
Biodel's senior management will host a conference call on December 11, 2007 beginning at 4:30 p.m., Eastern Standard Time, to discuss these financial 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 1-877-718-5104 (United States) or 1-719-325-4779 (international). To access the call by live audio webcast, please log on to the Investor section of the Company's website at http://www.biodel.com. An archived version of the audio webcast will be available at Biodel's website through January 11, 2007.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel(TM) technology, which reformulates existing FDA- approved peptide drugs. The Company's lead product candidate, VIAject(TM), is a rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM), a sublingual tablet formulation of insulin in a Phase I clinical trial and two osteoporosis product candidates in pre-clinical studies. For further information regarding Biodel, please visit the Company's website at http://www.biodel.com.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other then statements of historical facts, including statements
regarding our strategy, future operations, 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
Company's 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 secure FDA approval for our 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(TM) technology; the progress or success of our
research, development and clinical programs, the initiation and completion
of our clinical trials, the timing of the interim analyses and the timing
or success of our product candidates, particularly VIAject(TM) and
VIAtab(TM); our ability to secure additional patents for VIAject(TM) and
our other product candidates; 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
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. The
Company disclaims any obligation to update any forward-looking statements
as a result of events occurring after the date of this press release.
(A Development Stage Company)
(in thousands, except share and per share amounts)
Cash and cash equivalents $17,539 $80,022
Prepaid and other assets 79 505
Total current assets 17,618 80,527
Property and equipment, net 644 1,717
Intellectual property, net 208 262
Deferred public offering costs 189 -
Total assets $18,659 $82,506
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $1,357 $2,187
Clinical trial expenses - 1,164
Payroll and related 186 822
Accounting and legal fees - 335
Other 255 680
Income taxes payable 13 95
Due to related party 250 -
Deferred compensation 250 -
Total current liabilities 2,311 5,283
Preferred stock, $.01 par value; 50,000,000 shares
Series A convertible preferred stock, 1,050,000 shares
authorized, 569,000 and 0 shares issued
and outstanding, respectively, with a liquidation
preference of $2,845 and an 8% non-cumulative
dividend 6 -
Series B convertible preferred stock, 6,500,000 shares
authorized, 6,198,179 and 0 shares issued and
outstanding, respectively, with a
liquidation preference of $24,421 62 -
Common stock, $.01 par value; 100,000,000 shares
authorized; 5,360,430 and 20,160,836 issued
outstanding, respectively 54 202
Additional paid-in capital 29,054 116,854
Deficit accumulated during the development stage (12,828) (39,833)
Total stockholders' equity 16,348 77,223
Total liabilities and stockholders' equity $18,659 $82,506
(A Development Stage Company)
Statements of Operations
(in thousands, except share and per share amounts)
2005 2006 2007 2007
Revenue $ - $ - $ - $ -
Research and development 2,666 5,987 15,939 25,172
General and administrative 724 1,548 8,386 10,851
Total operating expenses 3,390 7,535 24,325 36,023
Other (income) and expense:
Interest and other income (9) (182) (1,902) (2,093)
Interest expense - 78 - 78
Loss on settlement of debt - 627 - 627
Operating loss before tax provision (3,381) (8,058) (22,423) (34,635)
Tax provision 2 10 125 138
Net loss (3,383) (8,068) (22,548) (34,773)
Charge for accretion of beneficial
conversion rights - (603) - (603)
Deemed dividend - warrants - - (4,457) (4,457)
Net loss applicable to common
stockholders $(3,383) $(8,671) $(27,005) $(39,833)
Net loss per share - basic and
diluted $(0.56) $(1.05) $(1.76)
Weighted average shares outstanding
- basic and diluted 6,080,746 8,252,113 15,354,898
|SOURCE Biodel Inc.|
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