0001145443-13-000269.txt : 20130212 0001145443-13-000269.hdr.sgml : 20130212 20130212164542 ACCESSION NUMBER: 0001145443-13-000269 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20130212 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130212 DATE AS OF CHANGE: 20130212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Biodel Inc CENTRAL INDEX KEY: 0001322505 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33451 FILM NUMBER: 13597830 BUSINESS ADDRESS: STREET 1: 100 SAW MILL ROAD CITY: DANBURY STATE: CT ZIP: 06810 BUSINESS PHONE: 203-796-5000 MAIL ADDRESS: STREET 1: 100 SAW MILL ROAD CITY: DANBURY STATE: CT ZIP: 06810 8-K 1 d30221.htm 8-K Converted by EDGARwiz



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

______________


FORM 8-K


CURRENT REPORT


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934



Date of report (Date of earliest event reported): February 12, 2013


BIODEL INC.
(Exact name of registrant as specified in its charter)



Commission File Number 001-33451


 

 

 

Delaware
(State or other jurisdiction of incorporation or organization)

 

90-0136863
(IRS Employer Identification Number)

 

 

 

100 Saw Mill Road

Danbury, Connecticut

(Address of principal executive offices)

 


06810

(Zip code)



(203) 796-5000

(Registrant's telephone number, including area code)



Not Applicable

(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


[  ]

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 2.02

Results of Operations and Financial Condition.


On February 12, 2013, Biodel Inc. (the " Company") issued a press release (the “Press Release”) announcing its financial results for its first fiscal year quarter ended December 31, 2012.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.


          

The information contained in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act except as expressly set forth by specific reference in such a filing.


Item 9.01   

Financial Statements and Exhibits.


(d)

Exhibits.


The following exhibit relating to Item 2.02 shall be deemed to be furnished and not filed:


99.1

Press Release issued by the Company on February 12, 2013.


2




SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date:  February 12, 2013 BIODEL INC.
   
   
  By:  /s/ Paul S. Bavier
  Paul S. Bavier, General Counsel and Secretary


3




EXHIBIT INDEX


Exhibit No.         Description
99.1
           
Press Release issued by the Company on February 12, 2013.
 



4




EX-99.1 2 d30221_ex99-1.htm EX-99.1 Exhibit 99

Exhibit 99.1

BIODEL REPORTS FIRST QUARTER FISCAL YEAR 2013 FINANCIAL RESULTS


Conference Call and Audio Webcast Will be Held Today, February 12th, at 5:00 p.m. ET


DANBURY, Conn., February 12, 2013 (GLOBE NEWSWIRE) - Biodel Inc. (Nasdaq: BIOD) today reported financial results for the first fiscal quarter ended December 31, 2012.


Highlights since first fiscal quarter:


·

Reported positive top line data from Phase 1 clinical trial of two Humalog®-based ultra-rapid-acting formulations, BIOD-238 and BIOD-250.


·

Phase 2 clinical trial of BIOD-123, an ultra-rapid-acting formulation of recombinant human insulin (RHI), enrolling according to schedule; top line data expected in the third calendar quarter of 2013.


Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “We are pleased to have demonstrated that we can produce an insulin analog-based formulation with an ultra-rapid-acting absorption profile similar to what we’ve observed with our RHI-based formulations. Equally important is replicating our achievement of improved absorption in a formulation with injection site tolerability similar to that of Humalog®. Demonstrating the broad utility of our technology across a number of different insulin molecules has expanded our strategic options as we look ahead to the Phase 2 data for BIOD-123.”


First Quarter Financial Results


Biodel reported a net loss for the three months ended December 31, 2012 of $3.7 million, or $0.26 per share, compared to a net loss of $4.5 million, or $0.47 per share, for the same period in the prior year.


Research and development expenses, net of $196 thousand of grant revenue, were $4.5 million for the three months ended December 31, 2012, compared to $2.4 million for the same period in the prior year. The increase in research and development expenses was primarily attributable to ongoing clinical trials.


General and administrative expenses were $1.4 million for the three months ended December 31, 2012, compared to $2.0 million for the same period in the prior year. The decrease in general and administrative expenses was primarily attributable to a decrease in stock based compensation expense.


Expenses for the three months ended December 31, 2012 and 2011 included costs of $0.5 million and $0.8 million, respectively, in stock-based compensation expense related to options granted to employees and non-employee directors. In addition, the results for the three months ended December 31, 2012 and 2011 included a decrease of $2.2 million and an increase of $0.1 million, respectively, in the fair value of the company’s common stock warrant liability.     




Aside from research and development grants in 2012, Biodel did not recognize any revenue during the three months ended December 31, 2012 or 2011.


At December 31, 2012, Biodel had cash and cash equivalents of $34.3 million and 14.2 million shares of common stock outstanding.


Conference Call and Webcast Information


Biodel's senior management will host a conference call on February 12, 2013 beginning at 5:00 p.m. Eastern 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 company's website at www.biodel.com. An archived version of the audio webcast will be available on Biodel's website. Interested parties may also access an audio replay by dialing (855) 859-2056 (US) or (404) 537-3406 (International) and entering conference ID number 97322985.


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.  


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 company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. 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, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes and our liquid glucagon formulation that is intended to treat patients




experiencing severe hypoglycemia; our ability to successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin or a liquid formulation of glucagon; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a liquid formulation of glucagon; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; 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 protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our 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 report on Form 10-K for the year ended September 30, 2012.  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)
Consolidated Condensed Balance Sheets
(in thousands, except share and per share amounts)

 

 

 

 

 

 

 

September 30,

 

December 31,

 

 

2012

 

2012

 

 

 

 

(unaudited)

ASSETS

 

 

 

 

 

 

 

 

Current:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

39,050

 

 

$

34,278

 

Restricted cash

 

 

60

 

 

 

60

 

Taxes receivable

 

 

34

 

 

 

34

 

Grant receivable

 

 

88

 

 

 

284

 

Other receivables

 

 

9

 

 

 

 

Prepaid and other assets

 

 

295

 

 

 

1,116

 

 

 

 

 

 

 

 

 

 

Total current assets

 

 

39,536

 

 

 

35,772

 

Property and equipment, net

 

 

1,552

 

 

 

1,473

 

Intellectual property, net

 

 

46

 

 

 

45

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

41,134

 

 

$

37,290

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current:

 

 

 

 

 

 

 

 

Accounts payable

 

$

285

 

 

$

1,129

 

Accrued expenses:

 

 

 

 

 

 

 

 

Clinical trial expenses

 

 

488

 

 

 

2,158

 

Payroll and related

 

 

1,248

 

 

 

499

 

Accounting and legal fees

 

 

244

 

 

 

230

 

Severance

 

 

141

 

 

 

 

Other

 

 

273

 

 

 

173

 

Income taxes payable

 

 

101

 

 

 

93

 

 

 

 

 

 

 

 

 

 

Total current liabilities

 

 

2,780

 

 

 

4,282

 

 

 

 

 

 

 

 

 

 

Common stock warrant liability

 

 

7,338

 

 

 

5,110

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

   10,118

 

 

 

9,392

 

Commitments

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Convertible Preferred stock, $.01 par value; 50,000,000 shares authorized, 5,419,551 issued and outstanding

 

 

54

 

 

 

54

 

Common stock, $.01 par value; 62,500,000 shares authorized; 14,174,545 and 14,177,220 issued and outstanding

 

 

142

 

 

 

142

 

Additional paid-in capital

 

 

226,913

 

 

 

227,464

 

Deficit accumulated during the development stage

 

 

(196,093

)

 

 

(199,762

)

 

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

 

31,016

 

 

 

27,898

 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

41,134

 

 

$

37,290

 

 

 

 

 

 

 

 

 

 




Biodel Inc.
(A Development Stage Company)

Consolidated Condensed Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 3,

 

 

 

 

 

 

 

 

 

 

2003

 

 

 

 

Three Months Ended

 

(inception) to

 

 

 

 

December 31,

 

December 31,

 

 

 

 

 

 

2011

 

2012

 

2012

Revenue

 

 

 

 

 

 

 

 

 

$

—  

 

 

$

—  

 

 

$

—  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

 

 

 

 

 

 

2,353

 

 

 

4,735

 

 

 

147,435

 

Government grant

 

 

 

 

 

 

 

 

 

 

 

 

 

(196

)

 

 

(284

)

General and administrative

 

 

 

 

 

 

 

 

 

 

2,020

 

 

 

1,370

 

 

 

65,132

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

 

 

 

 

 

 

 

 

 

4,373

 

 

 

5,909

 

 

 

212,283

 

Other (income) and expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

 

 

 

 

 

 

 

 

(24

)

 

 

(16

)

 

 

(5,662

)

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

78

 

Adjustment to fair value of common stock warrant liability

 

 

 

 

 

 

 

 

 

 

145

 

 

 

(2,228

)

 

 

(12,075

)

Loss on settlement of debt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

627

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before tax provision (benefit)

 

 

 

 

 

 

 

 

 

 

(4,494

)

 

 

(3,655

)

 

 

(195,251

)

Tax provision (benefit)

 

 

 

 

 

 

 

 

 

 

7

 

 

 

4

 

 

 

(549

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

(4,501

)

 

 

(3,669

)

 

 

(194,702

)

Charge for accretion of beneficial conversion rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(603

)

Deemed dividend — warrants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,457

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common stockholders

 

 

 

 

 

 

 

 

 

$

(4,501

)

 

 

(3,669

)

 

$

(199,762

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share — basic and diluted

 

 

 

 

 

 

 

 

 

$

(0.47

)

 

 

(0.26

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding — basic and diluted

 

 

 

 

 

 

 

 

 

 

9,673,529

 

 

 

14,176,057

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


BIOD-G

CONTACT: Seth D. Lewis, +1-646-378-2952

SOURCE Biodel Inc.

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