0001145443-15-000639.txt : 20150506 0001145443-15-000639.hdr.sgml : 20150506 20150506164519 ACCESSION NUMBER: 0001145443-15-000639 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150506 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150506 DATE AS OF CHANGE: 20150506 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: 15837587 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 biodel_8k.htm CURRENT REPORT

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): May 6, 2015
BIODEL INC.
(Exact name of registrant as specified in its charter)

Commission File Number 001-33451

Delaware 90-0136863
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification Number)
 
100 Saw Mill Road
Danbury, Connecticut 06810
(Address of principal executive offices) (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 May 6, 2015, Biodel Inc. (the "Company") issued a press release (the “Press Release”) announcing its financial results for its second fiscal year quarter ended March 31, 2015. 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 May 6, 2015.

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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:    May 6, 2015 BIODEL INC.
 
 
By:   /s/ Paul S. Bavier  
  Paul S. Bavier, General Counsel and Secretary

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EXHIBIT INDEX

Exhibit No. Description  
99.1       Press Release issued by the Company on May 6, 2015.

4


EX-99.1 2 exhibit99-1.htm PRESS RELEASE ISSUED BY THE COMPANY ON MAY 6, 2015

Exhibit 99.1

BIODEL REPORTS SECOND QUARTER FISCAL YEAR 2015 FINANCIAL RESULTS

Conference Call and Audio Webcast to be Held Today, May 6th, at 5:00 p.m. ET

DANBURY, Conn., May 6, 2015 (GLOBE NEWSWIRE) - Biodel Inc. (Nasdaq: BIOD) today reported financial results for the second fiscal quarter ended March 31, 2015.

Portfolio highlights since last fiscal quarter:

Announced positive clinical data from Study 6-101 demonstrating that administration of the formulation designed for use in the Glucagon Emergency Management (GEM) device results in glucagon exposure and glucose response that met standard bioequivalence criteria when compared to marketed glucagon
 

Announced results from a formative human factors study of its GEM device demonstrating a substantial improvement in ease of use and successful delivery of the full dose, as well as a reduction in dosing errors when compared to commercially available glucagon kits
 

Successfully completed a public offering, which generated approximately $32.1 million in net proceeds, including proceeds from the exercise of the over-allotment option
 

Received acceptance of 5 abstracts for presentation at the 2015 American Diabetes Association Scientific sessions. Four abstracts are on BIOD-531 and one is on the GEM program

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “This has been an extremely productive quarter for Biodel. With the exciting data from the recent clinical and human factor studies reported in the GEM program over the past two months and the continued progress made in the BIOD-531 program, coupled with our recent public offering, we are positioned to transition Biodel over the next 12 to 18 months to a later stage product development company with a diversified portfolio and significant potential to build shareholder value.”

Second Quarter Financial Results

Biodel reported a net loss of $4.4 million and $9.0 million, or $0.18 and $0.40 per share for the quarter and six month periods ended March 31, 2015, respectively. These results compare to a net loss of $6.2 million and $8.6 million, or $0.29 and $0.41 per share for the quarter and six month periods ended March 31, 2014, respectively.



Biodel did not recognize any revenue during the quarter and six month periods ended March 31, 2015 or 2014.

At March 31, 2015, Biodel had cash and cash equivalents of $17.8 million and 24.6 million shares of common stock outstanding. After giving effect of the recent public offering, Biodel had cash and cash equivalents of $49.8 million and 62.1 million shares of common stock outstanding.



Biodel Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)

September 30, March 31,
2014 2015
            (unaudited)
ASSETS
Current:
       Cash and cash equivalents $ 24,588 $ 17,753
       Prepaid and other assets 316 625
 
                     Total current assets 24,904 18,378
       Property and equipment, net 481 338
       Intellectual property, net 40 38
 
                     Total assets $ 25,425 $ 18,754
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current:
       Accounts payable $ 172 $ 346
       Accrued expenses:
              Clinical trial expenses 214 399  
              Payroll and related 958   986
              Accounting and legal fees 131     222
              Other   141 146
       Income taxes payable 3
 
                     Total current liabilities 1,616 2,102
 
       Common stock warrant liability 1,014 302
 
                     Total liabilities 2,630 2,404
Commitments
       Stockholders' equity:
       Convertible preferred stock, $.01 par value; 50,000,000 shares
              authorized; 1,950,000 and 1,909,410 issued and outstanding 19 19
       Common stock, $.01 par value; 200,000,000 shares authorized;
              23,079,543 and 24,620,322 issued and outstanding 231 246
       Additional paid-in capital 252,104 254,687
       Accumulated deficit          (229,559 )        (238,602 )
 
                     Total stockholders' equity 22,795 16,350
 
                     Total liabilities and stockholders' equity $ 25,425 $ 18,754



Biodel Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)

Three Months Ended Six Months Ended
March 31, March 31,
      2014       2015       2014       2015
Revenue $ $ $ $
 
Operating expenses:
       Research and development 4,257 2,917 7,998 6,324
       Government grants (207 ) (304 )
       General and administrative 1,731 1,611 3,127 3,444
 
Total operating expenses 5,781 4,528 10,821 9,768
Other (income) and expense:  
       Interest and other income (13 ) (7 ) (29 ) (16 )
       Adjustment to fair value of
              common stock warrant liability 426 (166 ) (2,161 ) (712 )
 
Loss before tax provision (6,194 ) (4,355 ) (8,631 )   (9,040 )
Tax provision 4 1 9 3
 
Net loss (6,198 ) (4,356 ) (8,640 ) (9,043 )
 
Net loss per share — basic and diluted $ (0.29 ) $ (0.18 ) $ (0.41 ) $ (0.40 )
 
Weighted average shares outstanding          
       — basic and diluted     21,083,237     24,369,246       21,078,404     22,809,903



Conference Call and Webcast Information

Biodel's senior management will host a conference call on May 6, 2015 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)407-7181 (United States) or +1 (201)689-8047 (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 (877) 660-6853 (US) (201) 612-7415 (International) and entering conference ID number 13588552.

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. Biodel's product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available 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 Biodel's product candidates, potential timing, design and outcomes of clinical trials and Biodel's ability to develop and commercialize its product candidates. Forward-looking statements represent Biodel's management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel's 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. Biodel'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 progress, timing or success of Biodel's research and development and clinical programs for Biodel's product candidates; Biodel's ability to conduct the development work necessary to finalize the formulation and design of Biodel's auto-reconstitution glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate; Biodel's ability to engage a strategic partner in the further development of Biodel's prandial ultra-rapid-acting insulin formulations, including BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient, and Biodel's insulin analog-based formulations; the success of Biodel's formulation development work to improve the stability of Biodel's newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations; the results of Biodel's real-time stability programs for Biodel's RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and Biodel's ability to accurately project long term stability on the basis of accelerated testing; Biodel's ability to accurately anticipate technical challenges that the company may face in the development of Biodel's ultra-rapid-acting RHI- and insulin analog-based product candidates or Biodel's glucagon rescue product candidates; Biodel's ability to secure approval by the FDA for Biodel's product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; Biodel's ability to enter into collaboration arrangements for the commercialization of Biodel's product candidates and the success or failure of any such collaborations into which the company enters, or Biodel's ability to commercialize its product candidates on its own; Biodel's ability to enforce Biodel's patents for Biodel's product candidates and Biodel's ability to secure additional patents for Biodel's product candidates; and other factors identified in our most recent annual report on Form 10-K for the fiscal year ended September 30, 2014 and other subsequent filings with the Securities and Exchange Commission. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.