ALBIREO PHARMA, INC. - Quarter Report: 2016 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2016 |
OR
| o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 For the transition period from ________ to ________. |
Commission File Number 001-33451
BIODEL INC.
(Exact name of registrant as specified in its charter)
|
Delaware (State or other jurisdiction of incorporation or organization) |
90-0136863 (IRS Employer Identification No.) |
||||
|
100 Saw Mill Road (Address of principal executive offices) |
06810 (Zip code) |
(203) 796-5000
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). x Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
| Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company x | ||||||||
| (Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
Indicate the number of shares outstanding of the issuer's common stock as of the latest practicable date: As of April 29, 2016 there were 64,148,271 shares of the registrant's common stock, $0.01 par value, outstanding.
| Page | |||||
| PART I — FINANCIAL INFORMATION | |||||
| Item 1. Financial Statements | 1 | ||||
| Condensed Consolidated Balance Sheets at September 30, 2015 and March 31, 2016 (unaudited) | 1 | ||||
| Condensed Consolidated Statements of Operations (unaudited) for the Three and Six Months Ended March 31, 2016 and 2015 | 2 | ||||
| Condensed Consolidated Statement of Stockholders' Equity (unaudited) for the period from September 30, 2015 through March 31, 2016 | 3 | ||||
| Condensed Consolidated Statements of Cash Flows (unaudited) for the Six Months Ended March 31, 2016 and 2015 | 4 | ||||
| Notes to Condensed Consolidated Financial Statements (unaudited) | 6 | ||||
| Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations | 18 | ||||
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 26 | ||||
| Item 4. Controls and Procedures | 27 | ||||
| PART II — OTHER INFORMATION | |||||
| Item 1. Legal Proceedings | |||||
| Item 5. Other Information | |||||
| Item 6. Exhibits | 29 | ||||
| Signatures | 30 | ||||
| EX-31.01 | |||||
| EX-31.02 | |||||
|
EX-32.01 |
|||||
|
EX-101 |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| September 30, 2015 |
March 31, 2016 |
|||||||||||||
| (unaudited) | ||||||||||||||
| ASSETS | ||||||||||||||
| Current: | ||||||||||||||
| Cash and cash equivalents | $ | 40,845 | $ | 33,433 | ||||||||||
| Restricted cash | — | 21 | ||||||||||||
| Prepaid and other assets | 262 | 684 | ||||||||||||
| Total current assets | 41,107 | 34,138 | ||||||||||||
| Property and equipment, net | 280 | — | ||||||||||||
| Intellectual property, net | 37 | 35 | ||||||||||||
| Total assets | $ | 41,424 | $ | 34,173 | ||||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||||
| Current: | ||||||||||||||
| Accounts payable | $ | 421 | $ | 115 | ||||||||||
| Accrued expenses: | ||||||||||||||
| Clinical trial expenses | 1 | 30 | ||||||||||||
| Payroll and related | 863 | 233 | ||||||||||||
| Accounting and legal fees | 289 | 269 | ||||||||||||
| Restructuring | — | 1,404 | ||||||||||||
| Other | 234 | 143 | ||||||||||||
| Income taxes payable | — | 16 | ||||||||||||
| Total current liabilities | 1,808 | 2,210 | ||||||||||||
| Common stock warrant liability | 5 | 3 | ||||||||||||
| Restructuring and other long term liabilities | 54 | 965 | ||||||||||||
| Total liabilities | 1,867 | 3,178 | ||||||||||||
| Commitments | ||||||||||||||
| Stockholders' equity: | ||||||||||||||
| Convertible preferred stock, $.01 par value; 50,000,000 shares authorized; 1,909,410 and 0 issued and outstanding | 19 | — | ||||||||||||
| Common stock, $.01 par value; 200,000,000 shares authorized; 62,151,202 and 64,148,271 issued and outstanding | 622 | 641 | ||||||||||||
| Additional paid-in capital | 287,212 | 287,733 | ||||||||||||
| Accumulated deficit | (248,296 | ) | (257,379 | ) | ||||||||||
| Total stockholders' equity | 39,557 | 30,995 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 41,424 | $ | 34,173 |
See accompanying notes to condensed consolidated financial statements.
-1-
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended March 31, |
Six Months Ended March 31, |
||||||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | ||||||||||||||||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||||||
| Research and development | 2,917 | 2,091 | 6,324 | 3,685 | |||||||||||||||||||||||||
| General and administrative | 1,611 | 3,989 | 3,444 | 5,621 | |||||||||||||||||||||||||
| Total operating expenses | 4,528 | 6,080 | 9,768 | 9,306 | |||||||||||||||||||||||||
| Other (income): | |||||||||||||||||||||||||||||
| Interest and other income | (7 | ) | (220 | ) | (16 | ) | (237 | ) | |||||||||||||||||||||
| Adjustment to fair value of common stock warrant liability | (166 | ) | — | (712 | ) | (2 | ) | ||||||||||||||||||||||
| Loss before tax provision | (4,355 | ) | (5,860 | ) | (9,040 | ) | (9,067 | ) | |||||||||||||||||||||
| Tax provision | 1 | 8 | 3 | 16 | |||||||||||||||||||||||||
| Net loss | (4,356 | ) | (5,868 | ) | (9,043 | ) | (9,083 | ) | |||||||||||||||||||||
| Net loss per share — basic and diluted | $ | (0.18 | ) | $ | (0.09 | ) | $ | (0.40 | ) | $ | (0.15 | ) | |||||||||||||||||
| Weighted average shares outstanding — basic and diluted | 24,369,246 | 64,148,271 | 22,809,903 | 61,053,997 | |||||||||||||||||||||||||
See accompanying notes to condensed consolidated financial statements.
-2-
Condensed Consolidated Statement of Stockholders' Equity
(in thousands, except share and per share amounts)
| Common Stock $.01 Par Value |
Series B Preferred stock $.01 Par Value |
Additional Paid in Capital |
Accumulated Deficit |
Total Stockholders' Equity |
||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance, September 30, 2015 | 62,151,202 | $ | 622 | 1,909,410 | $ | 19 | $ | 287,212 | $ | (248,296 | ) | $ | 39,557 | |||||||||||||||||||||||||||||||||||||
| Preferred stock conversion | 1,909,410 | 19 | (1,909,410 | ) | (19 | ) | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| RSU's Converted to common stock net of taxes withheld | 87,659 | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | 521 | — | 521 | |||||||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | (9,083 | ) | (9,083 | ) | |||||||||||||||||||||||||||||||||||||||||
| Balance, March 31, 2016 (unaudited) | 64,148,271 | $ | 641 | — | $ | — | $ | 287,733 | $ | (257,379 | ) | $ | 30,995 | |||||||||||||||||||||||||||||||||||||
See accompanying notes to condensed consolidated financial statements.
-3-
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
| Six Months Ended March 31, |
|||||||||||||||||
| 2015 | 2016 | ||||||||||||||||
| Cash flows from operating activities: | |||||||||||||||||
| Net loss | $ | (9,043 | ) | $ | (9,083 | ) | |||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||
| Depreciation and amortization | 164 | 80 | |||||||||||||||
| Gain on sale of property and equipment | — | (202 | ) | ||||||||||||||
| Stock-based compensation for employees and directors | 425 | 521 | |||||||||||||||
| Adjustment to fair value of common stock warrant liability | (712 | ) | (2 | ) | |||||||||||||
| (Increase) decrease in: | |||||||||||||||||
| Prepaid expenses and other assets | (309 | ) | (279 | ) | |||||||||||||
| Increase (decrease) in: | |||||||||||||||||
| Accounts payable | 174 | (306 | ) | ||||||||||||||
| Income taxes payable | 3 | 16 | |||||||||||||||
| Accrued expenses and long term liabilities | 309 | 1,603 | |||||||||||||||
| Total adjustments | 54 | 1,431 | |||||||||||||||
| Net cash used in operating activities | (8,989 | ) | (7,652 | ) | |||||||||||||
| Cash flows from investing activities: | |||||||||||||||||
| (Purchase)/Sales of property and equipment | (19 | ) | 261 | ||||||||||||||
| Net cash (used in) provided by investing activities | (19 | ) | 261 | ||||||||||||||
-4-
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
| Six Months Ended March 31, |
|||||||||||||||||
| 2015 | 2016 | ||||||||||||||||
| Cash flows from financing activities: | |||||||||||||||||
| Restricted cash | — | (21 | ) | ||||||||||||||
| Net proceeds from employee stock purchase plan | 10 | — | |||||||||||||||
| Net proceeds from ATM facility | 1,591 | — | |||||||||||||||
| Net proceeds from equity line | 672 | — | |||||||||||||||
| Fees associated with April 2015 offering | (100 | ) | — | ||||||||||||||
| Net cash provided by/(used in) financing activities | 2,173 | (21 | ) | ||||||||||||||
| Net decrease in cash and cash equivalents | (6,835 | ) | (7,412 | ) | |||||||||||||
| Cash and cash equivalents, beginning of period | 24,588 | 40,845 | |||||||||||||||
| Cash and cash equivalents, end of period | 17,753 | 33,433 | |||||||||||||||
| Supplemental disclosures of cash flow information: | |||||||||||||||||
| Cash paid for interest and income taxes was: | |||||||||||||||||
| Income taxes | — | 22 | |||||||||||||||
| Conversion of convertible preferred stock to common stock | $ | — | $ | 19 | |||||||||||||
| Other receivables for sale of property and equipment | $ | — | $ | 143 | |||||||||||||
See accompanying notes to condensed consolidated financial statements.
-5-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
Biodel Inc. and its wholly owned subsidiary (collectively, "Biodel" or the "Company") is a specialty pharmaceutical company located in Danbury, Connecticut. The Company was incorporated in the State of Delaware on December 3, 2003 and commenced operations in January 2004. The Company formed a wholly owned inactive subsidiary in the United Kingdom in October 2011 ("Biodel UK Limited").
The condensed consolidated financial statements have been prepared by the Company and are unaudited. These condensed consolidated financial statements include Biodel UK Limited. All intercompany balances and transactions have been eliminated. In the opinion of management, the Company has made all adjustments (consisting of normal recurring accruals) necessary to fairly present the financial position and results of operations for the interim periods presented. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with generally accepted accounting principles in the United States of America ("US GAAP") have been consolidated or omitted. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2015, filed with the Securities and Exchange Commission on December 22, 2015. The results of operations for the three and six months ended March 31, 2016 are not necessarily indicative of the operating results for the full fiscal year or any other interim period.
Restricted cash was $21 as of March 31, 2016 and $0 as of September 30, 2015. This amount was held in a money market account held with a bank to secure a credit card purchasing agreement utilized to facilitate employee travel and certain ordinary purchases.
The carrying amounts of the Company's financial instruments, which include cash and cash equivalents, and accounts payable, approximate their fair values due to their short term maturities.
ASC Topic 820 ("ASC 820") Fair Value Measurements applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, ASC 820 does not require any new fair value measurements. The fair value framework requires the categorization of assets and liabilities into three levels based upon the assumptions (inputs) used to price the assets or liabilities. The three levels of inputs used are as follows:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
As of September 30, 2015 and March 31, 2016, the Company had assets and liabilities that fell under the scope of ASC 820. The Company used the Black-Scholes valuation model to determine the fair value of the Company's warrant liability as of September 30, 2015 and March 31, 2016 for the warrants issued in the May 2011 and June 2012 financings (as defined in Note 7). The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. Accordingly, the Company's fair value measurements of its cash and cash equivalents are classified as a Level 1 input and the warrant liability as a Level 3 input. The fair value of the Company's financial assets and liabilities carried at fair value and measured on a recurring basis are as follows:
-6-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
| Description | Fair Value at March 31, 2016 |
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Market Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
||||||||||||||||||||||
| Assets: | ||||||||||||||||||||||||||
| Cash and cash equivalents and restricted cash | $ | 33,454 | $ | 33,454 | $ | — | $ | — | ||||||||||||||||||
| Subtotal | 33,454 | 33,454 | — | — | ||||||||||||||||||||||
| Liabilities: | ||||||||||||||||||||||||||
| Common stock warrant liability (see Note 7) | (3 | ) | — | — | (3 | ) | ||||||||||||||||||||
| Subtotal | (3 | ) | — | — | (3 | ) | ||||||||||||||||||||
| Total | $ | 33,451 | $ | 33,454 | $ | — | $ | (3 | ) |
| Description | Fair Value at September 30, 2015 |
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Market Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
||||||||||||||||||||||
| Assets: | ||||||||||||||||||||||||||
| Cash and cash equivalents | $ | 40,845 | $ | 40,845 | $ | — | $ | — | ||||||||||||||||||
| Subtotal | 40,845 | 40,845 | — | — | ||||||||||||||||||||||
| Liabilities: | ||||||||||||||||||||||||||
| Common stock warrant liability (see Note 7) | (5 | ) | — | — | (5 | ) | ||||||||||||||||||||
| Subtotal | (5 | ) | — | — | (5 | ) | ||||||||||||||||||||
| Total | $ | 40,840 | $ | 40,845 | $ | — | $ | (5 | ) |
The Company recognizes transfers into and out of the levels indicated above on the actual date of the event or change in circumstances that caused the transfer of change. All changes within Level 3 can be found in the following Level 3 reconciliation table below:
| Balance at September 30, 2015 | $ | (5 | ) | |||||
| Decrease in fair value of common stock warrant liability | 2 | |||||||
| Balance at March 31, 2016 | $ | (3 | ) |
The unrealized gains or losses on the derivative liabilities are recorded as an adjustment to fair value of derivative liabilities in the Company's statement of operations. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.
In March 2013, the Company's stockholders approved an amendment to and restatement of the Company's 2010 Stock Incentive Plan (as amended and restated the "2010 Plan"). The 2010 Plan replaced the Company's 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan. Stock options are granted at an exercise price equal to the Company's closing stock price on the date of the grant. Stock options vest over a period of up to four years with a contractual life of seven years. The Company estimates the fair value using the Black-Scholes pricing model. The Company uses the following assumptions in its Black Scholes valuation calculations:
-7-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
Risk-free rate - The Company uses interest rates based on the yield of US Treasury strips on the date the award is granted and the expected term of the award.
Forfeitures - The Company estimates forfeitures based on actual historical and estimated future forfeitures.
Dividends - The Company has assumed that dividends will not be paid.
Volatility - The Company uses its historical stock price volatility.
Expected term - The expected option term represents the period that stock based awards are expected to be outstanding based on the simplified method provided in Staff Accounting Bulletin ("SAB") No. 107, Share-Based Payment, ("SAB No. 107"), which averages an award's weighted-average vesting period and expected term for "plain vanilla" share options. Under SAB No. 107, options are considered to be "plain vanilla" if they have the following basic characteristics: (i) granted "at-the money" (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable.
In December 2007, the SEC issued SAB No. 110, Share-Based Payment ("SAB No. 110"). SAB No. 110 was effective January 1, 2008 and expresses the views of the Staff of the SEC with respect to extending the use of the simplified method, as discussed in SAB No. 107, in developing an estimate of the expected term of "plain vanilla" share options in accordance with ASC Topic 718. The Company will continue to use the simplified method until it has the historical data necessary to provide a reasonable estimate of expected life in accordance with SAB No. 107, as amended by SAB No. 110. For the expected term, the Company has "plain-vanilla" stock options, and therefore used a simple average of the vesting period and the contractual term for options granted subsequent to January 1, 2006 as permitted by SAB No. 107. The Company expenses ratably over the vesting period the cost of the stock options granted to employees and non-employee directors. The total compensation cost related to options for the three and six months ended March 31, 2016 was $411 and $521, respectively. In comparison, the total compensation cost related to options for the three and six months ended March 31, 2015 was $180 and $341, respectively. The March 31, 2016 expense includes a modification to extend the exercise period for employees affected by the October 2015 and January 2016 RIFs.
At March 31, 2016, the total compensation cost related to non-vested options not yet recognized was $399, which will be recognized over the next five years assuming the employees complete their service period for vesting of the options.
The following table summarizes the stock option activity during the six months ended March 31, 2016:
| Number | Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life in Years |
Aggregate Intrinsic Value |
|||||||||||||||||||||||
| Outstanding options, September 30, 2015 | 3,434,597 | $ | 8.61 | 5 | $ | — | ||||||||||||||||||||
| Granted | 1,750,000 | $ | 0.27 | 7 | 2 | |||||||||||||||||||||
| Forfeited, expired | (988,431 | ) | 15.38 | — | ||||||||||||||||||||||
| Outstanding options, March 31, 2016 | 4,196,166 | $ | 3.67 | 4 | 9 | |||||||||||||||||||||
| Exercisable options, March 31, 2016 | 2,199,419 | $ | 6.51 | 2 | $ | 3 |
The Black-Scholes pricing model assumptions for the options granted during the three and six months ended March 31, 2015 and 2016 are set forth below:
-8-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||||||||||||
| Expected life (in years) | 3.77-4.75 | 3.77-4.75 | 3.77 - 4.75 | 3.77 - 4.75 | ||||||||||||||||||||||
| Expected volatility | 62-82 | % | 65-67 | % | 62 - 82 | % | 65 - 67 | % | ||||||||||||||||||
| Expected dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||||||||
| Risk-free interest rate | 0.99 - 1.37 | % | 1.14 - 1.28 | % | 0.96 - 1.62 | % | 1.14 - 1.28 | % | ||||||||||||||||||
| Weighted average grant date fair value | $ | 1.39 | $ | 0.27 | $ | 1.39 | $ | 0.27 | ||||||||||||||||||
Restricted Stock Units
The Company has granted restricted stock units ("RSUs") to executive officers and employees pursuant to the 2010 Plan from time to time. There is no direct cost to the recipients of RSUs, except for any applicable taxes.
Each RSU award that was granted to the Company's executive officers and employees represents one share of common stock. Each year following the annual vesting date, between January 1st and March 15th, the Company will issue common stock for each vested RSU. During the period when the RSU is vested but not distributed, the RSUs cannot be transferred and the grantee has no voting rights. If the Company declares a dividend, RSU recipients will receive payment based upon the percentage of RSUs that has vested prior to the date of declaration. The costs of the awards, determined as the fair market value of the shares on the grant date, are expensed per the vesting schedule outlined in the award.
Based on historical experience of option cancellations, the Company has estimated an annualized forfeiture rate of 17.61%. Forfeiture rates are adjusted over the requisite service period when actual forfeitures differ, or are expected to differ, from the estimate. The stock-based compensation expense associated with the RSUs has been recorded in the statement of operations and in additional paid-in-capital on the balance sheets is as follows:
| Three Months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||||||||||||
| Stock compensation expense — RSUs | $ | 50 | $ | — | $ | 84 | $ | — | ||||||||||||||||||
The following table summarizes RSU activity from October 1, 2015 through March 31, 2016:
| Shares | Weighted Average Grant-Date Fair Value |
|||||||||||||
| Vested and not distributed balance at October 1, 2015 | 131,128 | $ | 1.57 | |||||||||||
| Changes during the period: | ||||||||||||||
| RSUs granted | — | — | ||||||||||||
| RSUs converted to common stock | (131,128 | ) | 1.57 | |||||||||||
| Vested and not distributed | — | — | ||||||||||||
| Non-vested and outstanding RSU balance at March 31, 2016 | — | $ | — |
The Company's 2005 Employee Stock Purchase Plan (the "Purchase Plan") was adopted by its board of directors and approved by its stockholders on March 20, 2007. The Purchase Plan became effective upon the closing of the Company's initial public offering. The Purchase Plan is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code.
Under the Purchase Plan, eligible employees may contribute up to 15% of their eligible earnings for the period of that offering to be withheld for the purchase of common stock under the Purchase Plan. The employee's purchase price is equal to the lower of: 85% of the fair market value per share on the start date of the offering period in which the
-9-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
employee is enrolled or 85% of the fair market value per share on the semi-annual purchase date. The Purchase Plan imposes a limitation upon a participant's right to acquire common stock if immediately after the purchase the employee would own 5% or more of the total combined voting power or value of the Company's common stock or of any of its affiliates. The Purchase Plan provides for an automatic rollover when the purchase price for a new offering period is lower than previously established purchase price(s). The Purchase Plan also provides for a one-time election that allows an employee the opportunity to enroll into a new offering period when the new offering is higher than their current offering price. This election must be made within 30 days from the start of a new offering period. Offering periods are twenty-seven months in length. The compensation charge/(credit) in connection with the Purchase Plan for the three and six months ended March 31, 2016 was $0. In comparison, for the three and six months ended March 31, 2015, the Company expensed $1 and $4, respectively.
An aggregate of 550,000 shares of common stock are reserved for issuance pursuant to purchase rights to be granted to the Company's eligible employees under the Purchase Plan. The Purchase Plan shares are replenished annually on the first day of each calendar year by virtue of an evergreen provision. The provision allows for share replenishment equal to the lesser of 1% of the total number of shares of common stock outstanding on that date or 25,000 shares. As of March 31, 2015 and 2016, a total of 401,262 and 395,382 shares, respectively, were reserved and available for issuance under the Purchase Plan. As of March 31, 2015 and 2016, the Company has issued 123,738 and 154,618 shares, respectively, under the Purchase Plan.
The Company accounts for income taxes under FASB ASC 740-10-25 ("ASC 740-10-25"), Accounting for Income Taxes. Under ASC 740-10-25, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740-10-25, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company files U.S. federal and state tax returns and has determined that its major tax jurisdictions are the United States and Connecticut. The tax years through 2015 remain open and subject to examination by the appropriate governmental agencies in the United States and Connecticut.
Section 382 of the Internal Revenue Code imposes limitations on the use of U.S. federal net operating losses ("NOLs") if there is more than a 50% change in ownership in the Company within a three-year period. The Company's NOLs will continue to be available to offset taxable income (until such NOLs are either used or expire) subject to the Section 382 annual limitation. If the Section 382 annual limitation amount is not fully utilized in a particular tax year, then the unused portion from that particular tax year will be added to the Section 382 annual limitation in subsequent years. The Company has determined that an ownership change, under Section 382, occurred as of December 31, 2013 and therefore, the ability to utilize its current NOLs is further limited.
The Company has approximately $31 million of U.S. federal NOLs and approximately $133 million of state NOLs, which, if not used, expire beginning in 2025 through 2035.
The Company's effective tax rate for the three and six months ended March 31, 2015 and 2016 was 0% and differs from the federal statutory rate of 34% due to net operating losses. A valuation allowance for the full amount of the deferred tax assets has been established as of September 30, 2015 and March 31, 2016.
Basic and diluted net loss per share has been calculated by dividing net loss by the weighted average number of common shares outstanding during the period. All potentially dilutive common shares have been excluded from the calculation of weighted average common shares outstanding, as their inclusion would be anti-dilutive.
The amount of options, common shares underlying warrants, common shares issuable upon conversion of preferred stock and RSUs excluded are as follows:
-10-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||||||||||||
| Common shares underlying warrants issued for common stock | 5,006,398 | 5,006,398 | 5,006,398 | 5,006,398 | ||||||||||||||||||||||
| Common shares issuable upon conversion of Series B Preferred Stock | 1,909,410 | — | 1,909,410 | — | ||||||||||||||||||||||
| Stock options | 3,510,316 | 4,196,166 | 3,510,316 | 4,196,166 | ||||||||||||||||||||||
| Restricted stock units outstanding | 131,128 | — | 131,128 | — | ||||||||||||||||||||||
On April 20, 2015, the Company completed an underwritten public offering of 37,500,000 shares of its common stock, which included the full exercise of the underwriter's option to purchase 4,891,304 shares to cover overallotments, at a price to the public of $0.92 per share. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses of $32,149.
On July 25, 2014, the Company entered into a purchase agreement (the "Purchase Agreement"), together with a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"). Under the terms, and subject to the conditions of the Purchase Agreement, the Company had the right to sell to LPC, and LPC was obligated to purchase, up to $15 million in shares of common stock, subject to certain limitations, from time to time over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the SEC pursuant to the Registration Rights Agreement, was declared effective by the SEC and a final prospectus in connection therewith was filed. The Company's registration statement was declared effective on September 2, 2014. The Company was obligated, within twenty (20) calendar days, to file with the SEC an initial Registration Statement covering the maximum number of Registrable Securities permitted to be included thereon in accordance with applicable SEC rules, regulations and interpretations so as to permit the resale of such Registrable Securities by LPC under Rule 415 under the Securities Act at then prevailing market prices (and not fixed prices), as mutually determined by both the Company and LPC in consultation with their respective legal counsel, subject to the aggregate number of authorized shares of the Company's Common Stock then available for issuance in its Certificate of Incorporation. The Company was required to use its commercially reasonable efforts to keep the Registration Statement effective pursuant to Rule 415 promulgated under the Securities Act and available for the resale by LPC of all of the Registrable Securities covered thereby at all times until the date on which LPC shall have resold all the Registrable Securities covered thereby and no available amount remained under the Purchase Agreement. The Company could direct LPC, at its sole discretion and subject to certain conditions, to purchase up to 150,000 shares of common stock in any business day, increasing to amounts of up to 250,000 shares, depending upon the closing sale price of the common stock. In addition, the Company could direct LPC to purchase additional shares as accelerated purchases if, on the date of a regular purchase, the closing sale price of the common stock was not below $2.50 per share (subject to adjustment). The purchase price of shares of common stock purchased under the Purchase Agreement were based on the prevailing market prices of such shares at the time of sales, but in no event could the Company sell shares to LPC on a day when the closing sale price of the common stock was less than a floor price of $1.50 per share (subject to adjustment). The Company could control the timing and amount of any sales of common stock to LPC under the Purchase Agreement. As consideration for LPC's commitment to purchase shares of common stock pursuant to the Purchase Agreement, the Company issued to LPC 95,000 shares of Common Stock as commitment shares, with a fair market value of $189, which is recorded as the cost of capital in additional paid in capital. In aggregate, the Company has sold 750,000 shares of common stock pursuant to the Purchase Agreement, and received proceeds, net of expenses, of $1,161.
-11-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
On April 14, 2015, the Company provided written notice of termination of the Purchase Agreement pursuant to the terms of the agreement. The termination became effective on April 16, 2015.
In May 2013, the Company entered into an At-the-Market Issuance Sales Agreement (the "Sales Agreement") with MLV & Co. LLC ("MLV"), under which the Company may initially issue and sell shares of common stock having aggregate sales proceeds of up to an additional $3,200 from time to time through MLV as the Company's sales agent. In aggregate, the Company has sold 2,607,535 shares of common stock pursuant to the Sales Agreement and received proceeds, net of sales agent commissions and expenses, of $4,700.
In June 2012, the Company completed a private placement (the "2012 Private Placement") of an aggregate of 4,250,020 shares of the Company's common stock, 3,605,607 shares of the Company's Series B Convertible Preferred Stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit consisting of either a share of common stock or Series B Preferred Stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the 2012 Private Placement paid a negotiated price of $2.355. The warrants were immediately exercisable and will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. The Company received net proceeds, after deducting placement agents' fees and other transaction expenses, of approximately $17,100 from the 2012 Private Placement. Each share of Series B Preferred Stock was convertible into one share of the Company's common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the "Securities Purchase Agreement") provides that a holder would be prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series B Preferred Stock will receive a payment equal to $0.01 per share of Series B Preferred Stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B Preferred Stock holders of Series B Preferred Stock would participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B Preferred Stock generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B Preferred Stock would be required to amend the terms of the Series B Preferred Stock. Holders of Series B Preferred Stock were entitled to receive, and the Company was required to pay, dividends on shares of the Series B Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) were paid on shares of the common stock. All Series B Preferred Stock has been converted into common stock and none remains outstanding.
As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the "Registration Statement") with the Securities and Exchange Commission (the "SEC") on July 27, 2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on August 13, 2012, registers the resale of the shares of common stock and Series B Preferred Stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B Preferred Stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a "Registration Default"). Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial
-12-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
statements, the Company does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages.
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the 2012 Private Placement will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.
At March 31, 2016, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $3. In comparison, the fair value of the warrant liability at September 30, 2015 was $5.
During the three and six months ended March 31, 2016, the Company recorded an adjustment to fair value of common stock warrant liability of $2 within Other income, to reflect a decrease in the valuation of the warrants from September 30, 2015 to March 31, 2016.
The following summarizes the changes in value of the warrant liability from September 30, 2015 through March 31, 2016:
| Balance at September 30, 2015 | $ | 5 | ||||||
| Decrease in fair value of common stock warrant liability | (2 | ) | ||||||
| Balance at March 31, 2016 | $ | 3 |
In May 2011, the Company completed a registered direct offering (the "May 2011 Offering") of an aggregate of 3,018,736 shares of the Company's common stock, 1,813,944 shares of the Company's Series A Preferred Stock and warrants to purchase 2,256,929 shares of the Company's common stock. The shares and warrants were sold in units consisting of (i) one share of common stock and (ii) one warrant to purchase 0.1625 of a share of common stock, at an exercise price of $9.92 per share of the Company's common stock. However, one investor also purchased units consisting of one share of Series A Preferred Stock and a warrant to purchase 0.1625 of a share of common stock. No fractional warrants were issued. Each unit was sold at a price of $8.64 per unit. These units were not issued or certificated. The shares and warrants were immediately separated. The warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. The Company received net proceeds, after deducting placement agents' fees and other offering expenses, of approximately $28,000 from the May 2011 Offering. Each share of Series A Preferred Stock was convertible into one quarter of a share of the Company's common stock at any time at the option of the holder, provided that the holder was prohibited from converting the shares of Series A Preferred Stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Company's common stock then issued and outstanding. All Series A Preferred Stock has been converted into common stock and none remains outstanding.
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the May 2011 Offering will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. As per terms of the warrant, the holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.
At March 31, 2016, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $0. In comparison, the fair value of the warrant liability at September 30, 2015 was $0.
-13-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
The Company has determined its warrant liability to be a Level 3 fair value measurement and used the Black-Scholes valuation model to calculate, as of March 31, 2016, the fair value of the warrants issued in the 2012 Private Placement and the May 2011 Offering.
As of March 31, 2016, the Company estimated such fair value using the following assumptions:
| June 2012 Private Placement | March 31, 2016 | |||||||
| Stock price | $ | 0.33 | ||||||
| Exercise price | $ | 2.66 | ||||||
| Risk-free interest rate | 0.59 | % | ||||||
| Expected remaining term (years) | 1.24 | |||||||
| Expected volatility | 75 | % | ||||||
| Dividend yield | — | |||||||
| Warrants outstanding | 2,749,469 |
| May 2011 Offering | March 31, 2016 | |||||||
| Stock price | $ | 0.33 | ||||||
| Exercise price | $ | 9.92 | ||||||
| Risk-free interest rate | 0.18 | % | ||||||
| Expected remaining term (years) | 0.13 | |||||||
| Expected volatility | 58 | % | ||||||
| Dividend yield | — | |||||||
| Warrants outstanding | 2,256,929 |
Risk-Free Interest Rate. This is the United States Treasury rate for the measurement date having a term equal to the expected remaining term of the warrant. An increase in the risk-free interest rate will increase the fair value and the associated derivative liability.
Term of Warrants. This is the period of time over which the warrant is expected to remain outstanding and is based on management's estimate of the remaining contractual life.
Expected Volatility. This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. The Company uses a weighted-average of its historic volatility over the retrospective period corresponding to the expected remaining term of the warrants on the measurement date. An increase in the expected volatility will increase the fair value and the associated derivative liability.
Dividend Yield. The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the fair value and the associated derivative liability.
If at any time the Company grants, issues or sells securities or other property to holders of any class of common stock, the holders of the warrants are entitled to also acquire those same securities as if they held the number of shares of common stock acquirable upon complete exercise of the warrants.
-14-
Biodel Inc.
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
As such, given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55 earnings per share. These securities were excluded from the three and six months ended March 31, 2015 and 2016 loss per share calculation since their inclusion would be anti-dilutive.
As of March 31, 2016, the Company leased three facilities in Danbury, Connecticut.
The Company extended its lease for laboratory space in January 2016 for an additional three months through April 30, 2016. This lease provides for annual basic lease payments of $68, plus the annual Consumers Price Index ("CPI") increase for October, not to exceed 6%, plus operating expenses. This lease expired on April 30, 2016 and was not renewed.
The Company also extended its lease agreement for additional office space adjacent to its laboratory space in January 2016 for an additional three months through April 30, 2016. This lease provides for annual basic lease payments of $31, plus the annual CPI increase for October, not to exceed 6%, plus operating expenses. This lease expired on April 30, 2016 and was not renewed.
In November 2013, the Company renewed its lease for its corporate office for five years. This lease provides for annual basic lease payments of $388, plus the annual CPI increase for May, not to exceed 6%, plus operating expenses.
Rent expense for the three and six months ended March 31, 2016 was $168 and $335, respectively. In comparison, rent expense for the three and six months ended March 31, 2015, was $167 and $333, respectively.
The Company has entered into certain licensing and collaboration agreements for products currently under development. The Company may be obligated in future periods to make additional payments, which would become due and payable only upon the achievement of certain research and development, regulatory, and approval milestones. The specific timing of such milestones cannot be predicted and depend upon future discretionary research and clinical developments, as well as, regulatory agency actions. Further, under the terms of certain agreements the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not considered contingent milestone payment amounts.
The Company follows the provisions of ASC Topic 420, "Exit or Disposal Cost Obligations", which addresses financial accounting and reporting for costs associated with exit or disposal activities. The statement requires companies to recognize costs associated with exit or disposal activities when they are incurred rather than at the date of a commitment to an exit or disposal plan. The Company records liabilities that primarily include severance and other costs related to employee benefits, as appropriate. Restructuring and other costs were $3,000 for the three months ended March 31, 2016 and $3,300 for the six months ended March 31, 2016, and represent severance and other costs related to employee benefits. These costs were expensed in the three and six months ended March 31, 2016, and are aggregated in the Condensed Consolidated Statement of Operations on the Research and development and General and administrative expense lines. The restructuring plan is primarily designed to reduce infrastructure and operational costs as the Company continues to explores its strategic alternatives. In comparison, restructuring and other costs were $0 for the three and six months ended March 31, 2015. The following summarizes the activities related to the restructuring accruals on the balance sheet:
| Current: | Total |
| Accrued restructuring balance at September 30, 2015 | $90 |
| Restructuring charges | 1,425 |
| Amortization | (21) |
| Accrued restructuring balance at March 31, 2016 | $1,404 |
Restructuring and other long term liabilities:
| Accrued restructuring balance at September 30, 2015 | $ 54 |
| Restructuring charges | 1,087 |
| Amortization | (176) |
| Restructuring and other long term liabilities balance at March 31, 2016 | $ 965 |
-15-
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q 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.
Our forward-looking statements in this Quarterly Report on Form 10-Q 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:
•the success of our efforts, and those of our advisors, in exploring, and possibly executing on, our strategic alternatives, while preserving our cash balance to the extent practicable;
•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our glucagon emergency management, or GEM, product candidate, which comprises lyophilized glucagon and an aqueous diluent in an automatic reconstitution device, and our concentrated ultra-rapid-acting insulin product candidate, BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient in a concentration of 400 units per milliliter;
•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate;
•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife Medical Solutions, Inc., or Unilife, which is responsible for designing and manufacturing the device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;
•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;
•our ability to accurately anticipate technical challenges that we may face in the development of our product candidates;
•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA;
•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;
•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 enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;
•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies or delivery devices, that could enable a room-temperature rescue product in a portable, easy to use presentation;
•the ability of our contract manufacturing organizations or collaborators to timely and properly produce our products in our final dosage form and in the quantities we may require;
•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization of one or more product candidates;
-16-
•our ability to maintain the listing of our common stock on the NASDAQ Capital Market;
•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and
•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2015, and in our other subsequent public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.
You should read this Quarterly Report and the documents that we have filed as exhibits to the Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. It is routine for internal projections and expectations to change as the year, or each quarter in the year, progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which we base our expectations are made as of the date of this Quarterly Report on Form 10-Q and may change prior to the end of each quarter or the year. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.
-17-
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read the "Risk Factors" section of our report on Form 10-K for the fiscal year ended September 30, 2015 and other subsequent filings with the Securities and Exchange Commission for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
We are 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 formulation technologies to existing drugs in order to improve their therapeutic profiles. Our glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with little to no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia. Our proprietary insulin formulations are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. We refer to these as "ultra-rapid-acting" insulin formulations.
Our lead glucagon product candidate is a glucagon emergency management, or GEM, drug-device combination that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. GEM is comprised of lyophilized glucagon and an aqueous diluent in a proprietary injection device from Unilife Medical Solutions, Inc., or Unilife. The GEM device is a dual-chamber design that automatically reconstitutes lyophilized glucagon immediately prior to injection and features automatic needle retraction on full dose delivery. GEM is designed with the goal of optimizing its ease of use for patient caregivers in an emergency.
In the third quarter of calendar year 2014, we submitted an Investigational New Drug application, or IND, to the U.S. Food and Drug Administration, or FDA, for our GEM product candidate. We have completed a Phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of BIOD-961, the reconstituted glucagon formulation intended for use in the GEM device. In the Phase 1 clinical trial, the overall pharmacokinetic and pharmacodynamic profiles of BIOD-961 were statistically indistinguishable from the two comparator glucagon formulations marketed by Eli Lilly and Novo Nordisk. In April 2015, we announced results from a formative human factors study of our GEM product candidate in which the GEM device demonstrated a substantial improvement in ease-of-use, frequency of successful administration and reduction in the error rate when compared to the commercially available glucagon kits. Despite these advancements, the timing of the development program for our GEM product candidate is uncertain. Further progress requires at least three registration batches of the fully filled and finished GEM device so that we may conduct the pivotal clinical study, human factors study and stability studies required for an NDA submission to the FDA. Previously, we anticipated that Unilife would deliver the registration batches toward the end of the 2015 calendar year. However, Unilife has informed us that the projected GEM device development timelines were no longer accurate, and discussions with Unilife to resolve a dispute regarding the requirements of our customization and commercial supply contract with them have been unsuccessful. We have initiated formal legal proceedings in Superior Court in the State of Connecticut and with the American Arbitration Association to address Unilife's alleged violation of the Connecticut Unfair Trade Practices Act, or CUTPA, and alleged breaches of contract in connection with the GEM program. Until such time as we are able to resolve these matters, if at all, we will be unable to continue to develop our GEM product candidate. We cannot give any assurance as to the outcome of our legal proceedings with Unilife or the ultimate development of our GEM product candidate.
In addition to our GEM product candidate, we have made efforts to develop ultra-rapid-acting proprietary insulin formulations that are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. BIOD-531, a concentrated ultra-rapid-acting insulin formulation, combines recombinant human insulin, or RHI, with our proprietary combination of excipients to increase the rate of absorption following subcutaneous injection when compared to other commercially available insulin formulations, including "rapid-acting" mealtime insulin analogs such as Humalog®, marketed by Eli Lilly, NovoLog®, marketed by Novo Nordisk, and Apidra®, marketed by Sanofi. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and is formulated with EDTA, citrate and magnesium sulfate. When delivered by subcutaneous injection, BIOD-531 is characterized by a rapid onset of action and a prolonged duration of action, which we believe could address an unmet medical need for a concentrated insulin with an initial rate of absorption superior to that of existing concentrated insulins and prandial/basal premixed insulins and comparable or superior to that of existing rapid-acting insulin analogs.
-18-
In addition to our RHI-based ultra-rapid-acting insulin formulations, we have used our proprietary excipients to develop pre-clinical analog-based ultra-rapid-acting insulin formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®.
In December 2015, we announced that our board of directors approved a plan to explore strategic alternatives to further realize value from our pipeline assets while preserving our cash balance to the extent practicable. In January 2016, we retained Ladenburg Thalmann & Co. to assist us in this process. Also in January 2016, we completed a reduction in force of 15 non-executive employees designed to reduce our operating expenditures while we explore our strategic alternatives. The January 2016 reduction in force is in addition to the ten-person reduction in force we completed in October 2015, which was designed to reduce infrastructure costs and improve efficiency of research and quality-related activities.
We were incorporated in December 2003 and commenced active operations in January 2004. To date, we have generated no revenues and have incurred significant losses. We expect to continue to incur operating losses as we continue our efforts to develop and commercialize our product candidates and execute on our strategic alternatives. We have financed our operations through various financing transactions, including our initial public offering in May 2007 and several subsequent transactions, including, most recently, our April 2015 underwritten public offering. In addition, we recently raised funds pursuant to our At-the-Market Issuance Sales Agreement with MLV & Co. LLC, or MLV, and our since-terminated equity line stock purchase agreement with Lincoln Park Capital Fund, LLC, or LPC. We may issue shares of our common stock pursuant to our agreement with MLV in the future. We have devoted substantially all of our efforts to research and development activities, including clinical trials. Our net loss was $5.9 million and $9.1 million for the three and six months ended March 31, 2016.
As of March 31, 2016 we had approximately $33.5 million in cash and cash equivalents, compared to $40.8 million in cash and cash equivalents as of September 30, 2015. We believe that our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses and capital expenditures for the foreseeable future.
To date, we have generated no revenues. We do not expect to begin generating any revenues unless any of our product candidates receive marketing approval, or if we receive payments in connection with strategic collaborations that we may enter into for the commercialization of our product candidates.
Research and development expenses consist of the costs associated with our basic research activities, as well as the costs associated with our drug development efforts, conducting preclinical studies and clinical trials, manufacturing efforts and activities related to regulatory filings. Our research and development expenses consist of:
•external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants;
•employee-related expenses, which include salaries and benefits for the personnel involved in our preclinical and clinical drug development and manufacturing activities; and
•facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies.
As a result of our reductions in force in October 2015 and January 2016, we expect that our research and development expenses for the fiscal year ending September 30, 2016 will decrease as compared to the fiscal year ended September 30, 2015, as we continue to explore our strategic options.
We have used our employee and infrastructure resources across multiple research projects and our drug development programs. A substantial majority of our research and development expenses incurred to date are attributable to our ultra-rapid-acting insulin program.
The following table illustrates, for each period presented, our research and development costs by nature of the cost.
-19-
| Three Months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||||||||||||
| Ultra-rapid-acting insulin formulations: | (in thousands) | |||||||||||||||||||||||||
| Research and development expenses: | ||||||||||||||||||||||||||
| Preclinical expenses | $ | 1,020 | $ | 504 | $ | 1,990 | $ | 1,119 | ||||||||||||||||||
| Manufacturing expenses | 628 | 649 | 1,494 | 1,061 | ||||||||||||||||||||||
| Clinical/regulatory expenses | 1,269 | 938 | 2,840 | 1,505 | ||||||||||||||||||||||
| Total | $ | 2,917 | $ | 2,091 | $ | 6,324 | $ | 3,685 | ||||||||||||||||||
The following table illustrates, for the three and six months ended March 31, 2015 and 2016, our research and development costs by project.
| Three Months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||||||||||
| 2015 | 2016 | 2015 | 2016 | |||||||||||||||||||||||
| Ultra-rapid-acting insulin formulations: | (in thousands) | |||||||||||||||||||||||||
| RHI/Analog | $ | (2 | ) | $ | -- | $ | 167 | $ | -- | |||||||||||||||||
| Glucagon Emergency Management (GEM) | 910 | 57 | 1,957 | 398 | ||||||||||||||||||||||
| BIOD-531 | 1,011 | 36 | 2,185 | 528 | ||||||||||||||||||||||
| Other | 998 | 1,998 | 2,015 | 2,759 | ||||||||||||||||||||||
| Total | $ | 2,917 | $ | 2,091 | $ | 6,324 | $ | 3,685 | ||||||||||||||||||
The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, specific timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from our product candidates. This is due to our limited resources we have available to us following our reductions in force in October 2015 and January 2016, as well as the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our glucagon emergency management, or GEM, product candidate, which comprises lyophilized glucagon and an aqueous diluent in an automatic reconstitution device, and our concentrated ultra-rapid-acting insulin product candidate, BIOD-531, which uses RHI as the active pharmaceutical ingredient in a concentration of 400 units per milliliter;
•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of an NDA to the FDA for that product candidate;
•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife Medical Solutions, Inc., or Unilife, which is responsible for designing and manufacturing the device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;
•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;
•our ability to accurately anticipate technical challenges that we may face in the development of our product candidates;
•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;
•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;
•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;
-20-
•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;
•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies or delivery devices, that could enable a room-temperature rescue product in a portable, easy to use presentation;
•the ability of our contract manufacturing organizations or collaborators to timely and properly produce our products in our final dosage form and in the quantities we may require;
•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;
•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and
•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.
A change in the outcome of any of these variables with respect to the development of ultra-rapid-acting insulin formulations or our GEM product candidate, could mean a significant change in the costs and timing associated with product development
General and administrative expenses consist primarily of salaries and related expenses for personnel, including stock-based compensation expenses, in our executive, legal, accounting, finance and information technology functions. Other general and administrative expenses include travel expenses, costs associated with industry conventions, professional fees, such as legal and accounting fees and consulting costs and facility-related costs not otherwise allocated to research and development expense.
We anticipate that our general and administrative core expenses in the fiscal year ending September 30, 2016 will decrease from the fiscal year ended September 30, 2015, with the exception of severance payments, as we continue to focus our efforts on preserving cash while we assess our options to maximize shareholder value. Over the longer term, however, these expenses could increase.
In June 2012, we issued warrants to purchase 2,749,469 shares of our common stock at an exercise price of $2.66 per share in connection with our June 2012 private placement. These warrants will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. In May 2011, we issued warrants to purchase 2,256,929 shares of our common stock at an exercise price of $9.92 per share in connection with our May 2011 registered direct offering. These warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. Under the terms of both the 2012 warrants and the 2011 warrants, if we enter into a merger or change of control transaction, the holders of the warrants will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require us to purchase the unexercised warrants at the Black-Scholes value (as defined in the applicable warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, we recognize the 2012 and 2011 warrants as liabilities at their fair value on each reporting date.
We use the Black-Scholes valuation model to estimate the fair value of the warrants. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. Using this model, we recorded an initial warrant liability of $4.8 million for the 2012 warrants and $9.4 million for the 2011 warrants, in each case as of the initial warrant issuance date. The liability for both the 2012 and 2011 warrants is revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."
Interest income consists of interest earned on our cash and cash equivalents and marketable securities. In November 2007, our board of directors approved investment policy guidelines, the primary objectives of which are the preservation of capital, the maintenance of liquidity and maintenance of appropriate fiduciary control - subject to our business
-21-
objectives and tax situation. We review this policy as needed, but minimally on an annual basis. We have maintained an investment strategy of investing primarily in a premier commercial money market account, which consists primarily of short-term debt securities issued by the U.S. government, Treasury securities and U.S. government agencies. We intend to maintain this conservative strategy for the fiscal year ending September 30, 2016.
Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements that have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and assumptions. We base our estimates on historical experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are described in Note 2 to our audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2015 and in the notes to our consolidated financial statements included in this Quarterly Report on Form 10-Q. We believe that our accounting policies relating to research and development costs, warrant liability, and stock-based compensation are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations. These policies are described under "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2015. There have been no material changes to such policies since the filing of such Annual Report.
Revenue. We did not recognize any revenue during the three months ended March 31, 2015 or 2016.
| Three Months Ended March 31, |
Decrease | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Research and Development | $ | 2,917 | $ | 2,091 | $ | 826 | 28.3 | % | ||||||||||||||||||
Research and development expenses were $2.1 million for the three months ended March 31, 2016, a decrease of $0.8 million, or approximately 28.3%, from $2.9 million for the three months ended March 31, 2015. This decrease was primarily due to a reduction in our research and clinical operations partially offset by severance obligations. Stock-based compensation included in research and development expenses were $0.1 million for the three months ended March 31, 2016 and the three months ended March 31, 2015.
| Three Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| General and Administrative | $ | 1,611 | $ | 3,989 | $ | 2,378 | 147.6 | % | ||||||||||||||||||
General and administrative expenses were approximately $4.0 million for the three months ended March 31, 2016, an increase of $2.4 million, or 147.6%, from $1.6 million for the three months ended March 31, 2015. This increase was primarily due to an increase in payroll and related costs of $1.9 million primarily associated with our severance
-22-
obligations and an increase in professional fees of $0.3 million. Stock-based compensation expenses were $0.3 million for the three months ended March 31, 2016, compared to $0.1 million for the three months ended March 31, 2015.
| Three Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Interest and Other Income | $ | 7 | $ | 220 | $ | 213 | 3,042.9 | % | ||||||||||||||||||
Interest and other income was $220 thousand for the three months ended March 31, 2016, compared to $7 thousand for the three months ended March 31, 2015. This increase is due to a gain on the sale of fixed assets of $202 thousand, as well as an increase of $11 thousand in interest income.
| Three Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Adjustment to fair value of common stock warrant liability | $ | (166 | ) | $ | 0 | $ | 166 | 100.0 | % | |||||||||||||||||
The change to fair value of common stock warrant liability during the three months ended March 31, 2016 was primarily a result of a decrease in the price of our common stock from $0.34 per share as of December 31, 2015 to $0.33 per share as of March 31, 2016. The change to fair value of common stock warrant liability during the three months ended March 31, 2015 was primarily a result of a decrease in the price of our common stock from $1.33 per share as of December 31, 2014 to $1.19 per share as of March 31, 2015.
| Three Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Net loss | $ | (4,356 | ) | $ | (5,868 | ) | $ | 1,512 | 34.7 | % | ||||||||||||||||
| Net loss per share | $ | (0.18 | ) | $ | (0.09 | ) | ||||||||||||||||||||
Net loss was $5.9 million, or $(0.09) per share, for the three months ended March 31, 2016, compared to $4.4 million, or $(0.18) per share, for the three months ended March 31, 2015. The increase in net loss was primarily attributable to the increased expenses described above. We expect our losses to continue for the foreseeable future as we explore our strategic alternatives.
Revenue. We did not recognize any revenue during the six months ended March 31, 2015 or 2016.
| Six Months Ended March 31, |
Decrease | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Research and Development | $ | 6,324 | $ | 3,685 | $ | 2,639 | 41.7 | % | ||||||||||||||||||
Research and development expenses were $3.7 million for the six months ended March 31, 2016, a decrease of $2.6 million, or 41.7%, from $6.3 million for the six months ended March 31, 2015. This decrease was primarily due to a
-23-
reduction in our research and clinical operations partially offset by severance obligations. Research and development expenses for the six months ended March 31, 2015 and 2016 include $0.1 million, respectively, in stock-based compensation expense.
| Six Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| General and Administrative | $ | 3,444 | $ | 5,621 | $ | 2,177 | 63.2 | % | ||||||||||||||||||
General and administrative expenses were approximately $5.6 million for the six months ended March 31, 2016, an increase of $2.2 million, or 63.2%, from $3.4 million for the six months ended March 31, 2015. This increase was primarily due to an increase in payroll and related costs of $1.8 million primarily associated with our severance obligations and an increase in professional fees of $0.1 million. General and administrative expenses for the six months ended March 31, 2015 and 2016 include $0.3 million and $0.4 million, respectively, in stock-based compensation expense related to options and RSUs granted to employees.
| Six Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Interest and Other Income | $ | 16 | $ | 237 | $ | 221 | 1,381.3 | % | ||||||||||||||||||
Interest and other income was $237 thousand for the six months ended March 31, 2016, compared to $16 thousand for the six months ended March 31, 2015. This increase is due to a gain on the sale of fixed assets of $202 thousand, as well as an increase of $19 thousand in interest income.
| Six Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Adjustment to fair value of common stock warrant liability | $ | (712 | ) | $ | (2 | ) | $ | 710 | 99.7 | % | ||||||||||||||||
The change to fair value of common stock warrant liability during the six months ended March 31, 2016 was primarily a result of a decrease in the price of our common stock from $0.44 per share as of September 30, 2015 to $0.33 per share as of March 31, 2016. The change to fair value of common stock warrant liability during the six months ended March 31, 2015 was primarily a result of a decrease in the price of our common stock from $1.67 per share as of September 30, 2014 to $1.19 per share as of March 31, 2015.
| Six Months Ended March 31, |
Increase | |||||||||||||||||||||||||
| 2015 | 2016 | $ | % | |||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
| Net loss | $ | (9,043 | ) | $ | (9,083 | ) | $ | 40 | 0 | % | ||||||||||||||||
| Net loss per share | $ | (0.40 | ) | $ | (0.15 | ) | ||||||||||||||||||||
-24-
Net loss was $9.1 million, or $(0.15) per share, for the six months ended March 31, 2016 compared to $9.0 million, or $(0.40) per share, for the six months ended March 31, 2015. We expect our losses to continue for the foreseeable future as we explore our strategic alternatives.
As a result of our significant research and development expenditures and the lack of any approved products or other sources of revenue, we have not been profitable and have generated significant operating losses since we were incorporated in 2003. We initially funded our research and development operations through aggregate gross proceeds of $26.6 million from our private financing transactions that we completed prior to our initial public offering. We received an aggregate of approximately $238 million from our initial public offering in May 2007, our follow-on offering in February 2008, our registered direct offerings in August 2010 and May 2011, our private placement in June 2012, our public offering in June 2013, our sales agreement with MLV, our purchase agreement with LPC, and our public offering in April 2015.
At March 31, 2016, we had cash and cash equivalents totaling approximately $33.5 million. We currently invest our excess funds in a premium commercial money market fund with one major financial institution. We plan to continue to invest our cash and cash equivalents in accordance with our approved investment policy guidelines, which set forth our policy to hold investment securities to maturity.
Net cash used in operating activities was $7.7 million for the six months ended March 31, 2016 and $9.0 million for the six months ended March 31, 2015. This decrease was primarily due to a decrease in operations partially offset by increased severance expenses during the period.
Net cash provided by/(used) in investing activities was $261 thousand for the six months ended March 31, 2016 and $(19) thousand for the six months ended March 31, 2015. This increase was primarily due to the sale of laboratory, manufacturing and device development fixed assets.
Net cash provided by/(used in) financing activities was $(21) thousand for the six months ended March 31, 2016 and $2.2 million for the six months ended March 31, 2015. Net cash used in financing activities for the six months ended March 31, 2016 reflects restricted cash held in a money market account to secure a credit card purchasing agreement. Net cash provided by financing activities for the six months ended March 31, 2015 reflect proceeds from the sale of our common stock through our equity line, ATM and our employee stock purchase plan.
We believe that our existing cash and cash equivalents at March 31, 2016 will be sufficient to fund our anticipated operating expenses and capital expenditures for the foreseeable future. We have based this estimate upon assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect. Our existing capital resources are not sufficient to complete our clinical development program for an ultra-rapid-acting insulin product candidate. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, and to the extent that we may or may not enter into collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current anticipated clinical trials. Our future capital requirements will depend on many factors, including:
•the success of our efforts, and those of our advisors, in exploring, and possibly executing on, our strategic alternatives, while preserving our cash balance to the extent practicable;
•the progress, timing or success of our research and development and clinical programs for our product candidates, particularly our glucagon emergency management, or GEM, product candidate, which comprises lyophilized glucagon and an aqueous diluent in an automatic reconstitution device, and our concentrated ultra-rapid-acting insulin product candidate, BIOD-531, which uses RHI as the active pharmaceutical ingredient in a concentration of 400 units per milliliter;
•our ability to conduct the development work necessary to finalize the formulation and presentation of our GEM product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the submission of an NDA to the FDA for that product candidate;
•the ability and willingness of our existing strategic partners, service providers and suppliers, upon which we rely in the advancement of our product candidates, to meet the obligations set forth in our agreements with them, including Unilife Medical Solutions, Inc., or Unilife, which is responsible for designing and manufacturing the
-25-
device intended for use with our GEM product candidate, as well as delivering three registration lots of the filled and finished GEM device required for submitting an NDA to the FDA;
•the results of our real-time stability programs for our glucagon-, RHI-, and insulin analog-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;
•our ability to accurately anticipate technical challenges that we may face in the development of our product candidates;
•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;
•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;
•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 enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;
•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies or delivery devices, that could enable a room-temperature rescue product in a portable, easy to use presentation;
•the ability of our contract manufacturing organizations or collaborators to timely and properly produce our products in our final dosage form and in the quantities we may require;
•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization of one or more product candidates;
•our ability to maintain the listing of our common stock on the NASDAQ Capital Market;
•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and
•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.
We do not anticipate generating product revenue for the next few years. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several years. To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Other than our agreement with MLV, we do not currently have any commitments for future external funding.
Currently, there are warrants outstanding from our May 2011 Offering and our 2012 Private Placement which have per share exercise prices of $9.92 and $2.66, respectively. These warrants will expire, if unexercised, on May 17, 2016 and June 26, 2017, respectively.
While we continue to pursue cost saving initiatives to reduce operating expenses, we may also need to raise additional funds and periodically explore sources of equity or debt financing. We may seek to raise such capital through public or private equity financings, partnerships, joint ventures, debt financings, bank borrowings or other sources. However, additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. If we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate some or all of our research and development programs. The accompanying financial statements do not include any adjustments that may result from the outcome of this uncertainty.
We have no off-balance sheet arrangements.
-26-
Our exposure to market risk is limited to our cash, cash equivalents and marketable securities. We invest in high-quality financial instruments, as permitted by the terms of our investment policy guidelines. Currently, our excess funds are invested in a premium commercial money market fund with one major financial institution. We do not hedge interest rate exposure. A portion of our investments may be subject to interest rate risk and could fall in value if interest rates were to increase. The effective duration of our portfolio is currently less than one year, which we believe limits interest rate and credit risk.
Because most of our transactions are denominated in United States dollars, we do not have any material exposure to fluctuations in currency exchange rates.
Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2016. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2016, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective.
No change in our internal control over financial reporting (defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 31, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
-27-
Item 1. Legal Proceedings
In July 2013, a third party initiated administrative proceedings in Munich, Germany before the European Patent Office to oppose two of our patents that have been granted in connection with our ultra-rapid-acting insulin formulations—EP 2 319 500 and EP2 106 790. The opponent was listed as Dr. Armin K. Bohmann. The opponent requested that the patents be revoked, alleging that the subject matter was not patentable, the inventions were not adequately disclosed and the subject matter extended beyond the subject of the applications. In an October 2014 ruling, which the opponent has appealed, the Opposition Division of the European Patent Office found that all claims of both patents are novel and inventive.
In September 2015, we filed a complaint in Superior Court in the State of Connecticut (Judicial District of Danbury) against Unilife. The complaint contains two counts. The First Count seeks injunctive relief pending arbitration of certain contract claims relating to our GEM program. The Second Count seeks compensatory and punitive damages from Unilife based on its alleged violation of the Connecticut Unfair Trade Practices Act in connection with our GEM program. In November 2015, we also filed a demand for arbitration with the American Arbitration Association relating to alleged breaches by Unilife of its contractual obligations to develop and supply the injection device intended for use with our GEM product candidate.
Item 5. Other Information
On January 26, 2016, Dr. Errol B. De Souza stepped down from his positions as President and Chief Executive Officer and a member of the board of directors of Biodel. Dr. De Souza's departure was not the result of a disagreement with Biodel on any matter relating to our operations, policies or practices.
-28-
| Exhibit No. | Description | |||||||
| 10.01 | General Release & Waiver Agreement, dated February 26, 2016, between the Registrant and Errol B. De Souza. | |||||||
| 31.01 | Chief Executive Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
| 31.02 | Chief Financial Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
| 32.01 |
Chief Executive Officer and Chief Financial Officer—Certification
pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities
Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes- Oxley Act of 2002.
|
|||||||
| 101 |
Interactive data files pursuant to Rule 405 of Regulation S-T. |
-29-
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 thereunto duly authorized.
| BIODEL INC. | ||||||||
| Dated: May 10, 2016 | By: | /s/ Gary G. Gemignani | ||||||
| Gary G. Gemignani, Chief Financial Officer | ||||||||
| (Duly authorized officer and principal financial officer) | ||||||||
-30-
| Exhibit No. | Description | |||||||
| 10.01 | General Release & Waiver Agreement, dated February 26, 2016, between the Registrant and Errol B. De Souza. | |||||||
| 31.01 | Chief Executive Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
| 31.02 | Chief Financial Officer—Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
| 32.01 | Chief Executive Officer and Chief Financial Officer—Certification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002. | |||||||
| 101 | Interactive data files pursuant to Rule 405 of Regulation S-T. |
-31-