Exhibit 99.1
Biodel Reports Third Quarter Fiscal Year 2009 Financial Results
DANBURY, Conn., August 7, 2009 — Biodel Inc. (Nasdaq: BIOD) today reported financial results for the third quarter ended June 30, 2009.
Third Quarter Fiscal Year 2009 Financial Results
Biodel reported a net loss for the quarter ended June 30, 2009 of $11.1 million, or $0.47 per share, compared to a net loss of $10.1 million, or $0.43 per share, for the comparable period in the prior year.
Research and development expenses were $8.0 million for the three months ended June 30, 2009, compared to $6.9 million for the same period in the prior year. The increase in quarterly expenses was primarily due to costs related to the purchase of recombinant human insulin to build commercial supply inventory for VIAject® and a slight increase in personnel expenses related to stock-based compensation. These increases were offset by reductions in certain clinical and manufacturing expenses.
General and administrative expenses totaled $2.7 million for the three months ended June 30, 2009, compared to $4.2 million for the same period in the prior year. The decrease in general and administrative expenses was attributable to reductions in stock-based compensation, professional fees and travel expenses.
Expenses for the three months ended June 30, 2009 and 2008 include $1.3 million and $1.9 million, respectively, in stock-based compensation expense related to options granted to employees and non-employees.
Biodel did not recognize any revenue during the third quarter of fiscal years 2009 or 2008.
At the end of June 2009, Biodel had cash, cash equivalents and marketable securities of $64.6 million and 23.8 million shares outstanding.
VIAject® Update
During the quarter, Biodel continued its work to prepare a new drug application (NDA) for submission to the U.S. Food and Drug Administration by the end of calendar year 2009 for approval to market VIAjectÒ for the treatment of diabetes. The NDA will be based upon results from multiple pharmacokinetic, pharmacodynamic and standardized meal studies as well as the two completed Phase 3 studies of VIAjectÒ in patients with Type 1 and Type 2 diabetes. Biodel is now preparing its NDA submission and initiating studies designed to further differentiate the therapeutic potential of VIAject® from existing rapid-acting prandial insulins.
Conference Call and Webcast Information
Biodel’s senior management will host a conference call on August 7, 2009 beginning at 9 am 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 1-877-591-4949 (United States) or 1-719-325-4889 (international). To access the call by live audio webcast, please log on to the investor section of the company’s website atwww.biodel.com. An archived version of the audio webcast will be available at Biodel’s website.
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 using VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. For further information regarding Biodel, please visit the company’s website atwww.Biodel.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s 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 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 have our VIAject® NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject® 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, particularly VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA’s findings regarding data anomalies observed in India in our Phase III clinical trial of VIAject® for patients with Type 1 diabetes; 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 March 31, 2009. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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, | |||||||
| 2008 | 2009 | |||||||
| (unaudited) | ||||||||
ASSETS | ||||||||
| Current: | ||||||||
| Cash and cash equivalents | $ | 64,731 | $ | 63,567 | ||||
| Marketable securities, available for sale | 25,552 | 1,000 | ||||||
| Taxes receivable | 1,988 | 580 | ||||||
| Prepaid and other assets | 1,130 | 497 | ||||||
| Total current assets | 93,401 | 65,644 | ||||||
| Property and equipment, net | 3,931 | 3,461 | ||||||
| Intellectual property, net | 59 | 57 | ||||||
| Other assets | 120 | — | ||||||
| Total assets | $ | 97,511 | $ | 69,162 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current: | ||||||||
| Accounts payable | $ | 813 | $ | 273 | ||||
| Accrued expenses: | ||||||||
| Clinical trial expenses | 4,163 | 6,472 | ||||||
| Payroll and related | 1,420 | 1,216 | ||||||
| Accounting and legal fees | 509 | 432 | ||||||
| Severance expense | 268 | 267 | ||||||
| Other | 839 | 624 | ||||||
| Income taxes payable | 1,012 | 37 | ||||||
| Total current liabilities | 9,024 | 9,321 | ||||||
| Commitments | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.01 par value; 50,000,000 shares authorized | — | — | ||||||
| Common stock, $0.01 par value; 100,000,000 shares authorized; 23,698,558 and 23,796,587 shares issued and outstanding | 237 | 238 | ||||||
| Additional paid-in capital | 171,506 | 175,598 | ||||||
| Accumulated other comprehensive (loss) income | (62 | ) | — | |||||
| Deficit accumulated during the development stage | (83,194 | ) | (115,995 | ) | ||||
| Total stockholders’ equity | 88,487 | 59,841 | ||||||
| Total liabilities and stockholders’ equity | $ | 97,511 | $ | 69,162 | ||||
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, | ||||||||||||||||||||
| 2003 | ||||||||||||||||||||
| Three Months Ended | Nine Months Ended | (inception) to | ||||||||||||||||||
| June 30, | June 30, | June 30, | ||||||||||||||||||
| 2008 | 2009 | 2008 | 2009 | 2009 | ||||||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 6,884 | 7,991 | 21,525 | 24,387 | 82,113 | |||||||||||||||
| General and administrative | 4,161 | 2,692 | 11,836 | 8,408 | 34,059 | |||||||||||||||
| Total operating expenses | 11,045 | 10,683 | 33,361 | 32,795 | 116,172 | |||||||||||||||
| Other (income) and expense: | ||||||||||||||||||||
| Interest and other income | (390 | ) | (54 | ) | (2,174 | ) | (374 | ) | (5,477 | ) | ||||||||||
| Interest expense | — | — | — | — | 78 | |||||||||||||||
| Loss on settlement of debt | — | — | — | — | 627 | |||||||||||||||
| Operating loss before tax provision (benefit) | (10,655 | ) | (10,629 | ) | (31,187 | ) | (32,421 | ) | (111,400 | ) | ||||||||||
| Tax provision (benefit) | (544 | ) | 519 | (491 | ) | 380 | (465 | ) | ||||||||||||
| Net loss | (10,111 | ) | (11,148 | ) | (30,696 | ) | (32,801 | ) | (110,935 | ) | ||||||||||
| Charge for accretion of beneficial conversion rights | — | — | — | — | (603 | ) | ||||||||||||||
| Deemed dividend — warrants | — | — | — | — | (4,457 | ) | ||||||||||||||
| Net loss applicable to common stockholders | $ | (10,111 | ) | $ | (11,148 | ) | $ | (30,696 | ) | $ | (32,801 | ) | $ | (115,995 | ) | |||||
| Net loss per share — basic and diluted | $ | (0.43 | ) | $ | (0.47 | ) | $ | (1.40 | ) | $ | (1.38 | ) | ||||||||
| Weighted average shares outstanding — basic and diluted | 23,653,956 | 23,759,675 | 21,959,335 | 23,727,833 | ||||||||||||||||