þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . |
Delaware (State or Other Jurisdiction of Incorporation or Organization) | 90-0136863 (I.R.S. Employer Identification No.) | |||||
100 Saw Mill Road Danbury, CT (Address of Principal Executive Offices) | 06810 (Zip Code) |
Title of Each Class | Name of Each Exchange on Which Registered | |||||
Common Stock, par value $0.01 per share | The NASDAQ |
Large accelerated filero | Accelerated filero |
Non-accelerated filero | Smaller reporting companyþ |
Page | ||||||||||||
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PART I | ||||||||||||
Item 1: | Business | 3 | ||||||||||
Item 1A: | Risk Factors | |||||||||||
Item 1B: | Unresolved Staff Comments | |||||||||||
Item 2: | Properties | |||||||||||
Item 3: | Legal Proceedings | |||||||||||
Item 4: | Mine Safety Disclosure | |||||||||||
PART II | ||||||||||||
Item 5: | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | |||||||||||
Item 6: | Selected Financial Data | |||||||||||
Item 7: | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |||||||||||
Item 7A: | Quantitative and Qualitative Disclosures About Market Risk | |||||||||||
Item 8: | Financial Statements and Supplementary Data | |||||||||||
Item 9: | Changes in and Disagreements With Accountants on Accounting and Financial | |||||||||||
Item 9A: | Controls and Procedures | |||||||||||
PART III | ||||||||||||
Item 10: | Directors, Executive Officers and Corporate Governance | |||||||||||
Item 11: | Executive Compensation | |||||||||||
Item 12: | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | |||||||||||
Item 13: | Certain Relationships and Related Transactions, and Director Independence | |||||||||||
Item 14: | Principal Accountant Fees and Services | |||||||||||
PART IV | ||||||||||||
Item 15: | Exhibits, | |||||||||||
EX-3.5 | ||||||||||||
EX-10.19 | ||||||||||||
EX-10.20 | ||||||||||||
EX-21.1 | ||||||||||||
EX-23.1 | ||||||||||||
EX-31.01 | ||||||||||||
EX-31.02 | ||||||||||||
EX-32.01 |
• | the progress, timing or success of our research and development and clinical programs for our product candidates, |
• | our |
• | the success of our formulation development work to |
• | our ability to |
• | the results of our real-time stability programs for our insulin and glucagon product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project real-time stability on the basis of accelerated testing; |
• | our ability to accurately anticipate technical challenges we may face in the development of a glucagon rescue product candidate; |
• | our ability to secure approval by the U.S. Food and Drug Administration, or FDA, for our product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA; |
• |
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a |
• | 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 degree of clinical utility of our |
• | the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation; |
• | the ability of our major suppliers to produce our products in our final dosage form; |
• | our commercialization, marketing and manufacturing capabilities and strategies; and |
• | our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing. |
• | completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; |
• | submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin; |
• | for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA’s regulations, including Good Clinical Practices, to establish the safety and efficacy of the product candidate for each proposed indication; |
• | submission to the FDA of an |
• | satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, regulations; and |
• | FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug. |
• | Phase 1 clinical trials typically involve the initial introduction of the product candidate into |
• | Phase 2 clinical trials are conducted in a limited patient population to gather evidence about the efficacy of the product candidate for specific, targeted |
• | Phase 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical trial sites. The size of Phase 3 clinical trials depends upon clinical and statistical considerations for the product candidate and |
• | record-keeping requirements; |
• | reporting of adverse experiences with the drug; |
• | providing the FDA with updated safety and efficacy information; |
• | reporting on advertisements and promotional labeling; |
• | drug sampling and distribution requirements; and |
• | complying with electronic record and signature requirements. |
Name | Age | Position | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Dr. Errol B. De Souza | 59 | President and Chief Executive Officer | ||||||||
Gerard Michel | 49 | Chief Financial Officer | ||||||||
Dr. Alan Krasner | 49 | Chief Medical Officer | ||||||||
Paul Bavier | 40 | General Counsel and Secretary | ||||||||
Erik Steiner | 46 | Vice President, Operations |
• | conduct |
• |
• | conduct later stage clinical trials of our ultra-rapid-acting insulin formulations and a liquid glucagon formulation, including one or more pivotal clinical trials required for FDA approval of the NDAs; |
• | produce validation batches of our product candidates to |
• | conduct additional |
• | conduct the required stability, preclinical and human factors and user acceptability studies to support the approval of |
• | purchase |
• | conduct |
• | the progress, timing or success of our |
• | our ability to |
• | the success of our formulation development work to improve the stability, pharmacokinetic and pharmacodynamic characteristics of our ultra-rapid-acting |
• | our ability to conduct the development work necessary to select a lead formulation for our liquid glucagon product candidate for the rescue treatment of severe hypoglycemia and commence clinical trials of that formulation; |
• | the results of our real-time stability programs for our insulin and |
• | our ability to accurately anticipate technical challenges that we may face in the development of a glucagon rescue product candidate; |
• | our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the |
• | our ability to conduct |
• | our ability to enter into collaboration arrangements for the |
• |
• | our ability to protect our intellectual property and operate our business without infringing upon the |
• | 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; |
• | the emergence of competing technologies and products and other adverse market |
• | the ability of our major suppliers to produce our products in our final dosage form; |
• | our commercialization, marketing and manufacturing capabilities and strategies; and |
• | our ability to |
• | successful completion of preclinical development and clinical trials; |
• | our ability to identify and enroll patients who meet clinical trial eligibility criteria; |
• | receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States; |
• | establishing that, with regard an RHI- or insulin analog based-formulation, the formulation is well-tolerated in chronic use; |
• | establishing that, with regard to a liquid glucagon formulation for use as a rescue product, the commercial presentation can be administered effectively by patient caregivers with limited or no training; |
• | establishing commercial manufacturing capabilities through arrangements with third-party manufacturers; |
• | launching commercial sales of the products, whether alone or in collaboration with others; |
• | competition from other products; and |
• | continued acceptable safety and |
• | the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we currently anticipate, or participants may drop out of our clinical trials at a higher rate than we anticipate, any of which would result in significant delays; |
• | our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; |
• | we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks; |
• | regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; |
• | the cost of our clinical trials may be greater than we anticipate; |
• | the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate; and |
• | the effects of our product candidates may not be the desired effects, may include undesirable side effects or the product candidates may have other unexpected characteristics. |
• | be delayed in obtaining or discontinue our efforts to obtain marketing approval; |
• | not be able to obtain marketing approval; |
• | obtain approval for indications that are not as broad as intended; or |
• | have the product removed from the market after obtaining marketing approval. |
• | a change in the labeling statements or withdrawal of FDA or other regulatory approval of the product; |
• | a change in the way the product is administered; or |
• | the need to conduct additional clinical trials. |
• | the willingness and ability of patients and the healthcare community to adopt our products; |
• | the ability to manufacture our product candidates in sufficient quantities with acceptable quality and to offer our product candidates for sale at competitive prices; |
• | the perception of patients and the healthcare community, including third-party payors, regarding the safety, efficacy and benefits of our product candidates compared to those of competing products or therapies; |
• | the convenience and ease of administration of our product candidates relative to existing treatment methods; |
• | the label and promotional claims allowed by the FDA, such as, in the case of an RHI- or insulin analog-based formulation, claims relating to glycemic control, hypoglycemia, weight gain, injection site discomfort, expiry dating and required handling conditions; |
• | the pricing and reimbursement of our product candidates relative to existing treatments; and |
• | marketing and distribution support for our product candidates. |
• | a covered benefit under its health plan; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
• | decreased demand for any product candidates or products that we may develop; |
• | injury to our reputation; |
• | withdrawal of clinical trial participants; |
• | costs to defend the related litigation; |
• | substantial monetary awards to trial participants or patients; |
• | loss of revenue; and |
• | the inability to commercialize any products that we may develop. |
• | significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize product candidates; |
• | more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products; |
• | product candidates that have been approved or are in late-stage clinical development; or |
• | collaborative arrangements in our target markets with leading companies and research institutions. |
• | reliance on the third party for regulatory compliance and quality assurance; |
• | the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and |
• | the possible refusal by or inability of the third party to support our manufacturing programs in a time frame that we would otherwise prefer. |
• | receiving patent protection for our product candidates; |
• | maintaining our trade secrets; |
• | not infringing on the proprietary rights of others; and |
• | preventing others from infringing our proprietary rights. |
• | restrictions on such products’ manufacturers or manufacturing processes; |
• | restrictions on the marketing or distribution of a product; |
• | requirements that we conduct new studies, make labeling changes, and implement Risk Evaluation and Mitigation Strategies; |
• | warning letters; |
• | withdrawal of the products from the market; |
• | refusal to approve pending applications or supplements to approved applications that we submit; |
• | recall of products; |
• | fines, restitution or disgorgement of profits or revenue; |
• | suspension or withdrawal of regulatory approvals; |
• | refusal to permit the import or export of our products; |
• | product embargo and/or seizure; |
• | injunctions; or |
• | imposition of civil or criminal penalties. |
• | establish a classified board of directors such that not all members of the board are elected at one time; |
• | allow the authorized number of our directors to be changed only by resolution of our board of directors; |
• | limit the manner in which stockholders can remove directors from the board; |
• | establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors; |
• | require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; |
• | limit who may call stockholder meetings; |
• | authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a stockholder rights plan or “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and |
• | require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws. |
• | results of clinical trials of our product candidates or those of our competitors; |
• | regulatory or legal developments in the United States and other countries; |
• | variations in our financial results or those of companies that are perceived to be similar to us; |
• | developments or disputes concerning patents or other proprietary rights; |
• | the recruitment or departure of key personnel; |
• | changes in the structure of healthcare payment systems; |
• | market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations; |
• | general economic, industry and market conditions; and |
• | the other factors described in this “Risk Factors” section. |
ITEM | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
Quarter Ended | High | Low | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
December 31, 2009 | $ | 5.39 | $ | 3.29 | ||||||
March 31, 2010 | $ | 5.30 | $ | 3.22 | ||||||
June 30, 2010 | $ | 6.25 | $ | 3.74 | ||||||
September 30, 2010 | $ | 6.08 | $ | 3.25 | ||||||
December 31, 2010 | $ | 5.32 | $ | 1.50 | ||||||
March 31, 2011 | $ | 2.97 | $ | 1.82 | ||||||
June 30, 2011 | $ | 2.59 | $ | 1.49 | ||||||
September 30, 2011 | $ | 2.13 | $ | 0.51 |
Fiscal Quarter Ended | High | Low | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
December 31, 2010 | $ | 21.28 | $ | 6.00 | ||||||
March 31, 2011 | $ | 11.88 | $ | 7.28 | ||||||
June 30, 2011 | $ | 10.36 | $ | 5.96 | ||||||
September 30, 2011 | $ | 8.52 | $ | 2.04 | ||||||
December 31, 2011 | $ | 3.48 | $ | 2.04 | ||||||
March 31, 2012 | $ | 2.96 | $ | 2.24 | ||||||
June 30, 2012 | $ | 4.00 | $ | 2.00 | ||||||
September 30, 2012 | $ | 3.82 | $ | 2.41 |
Period | (a) Total number of shares (or units) purchased | (b) Average price paid per share (or unit) | (c) Total number of shares (or units) purchased as part of publicly announced plans or programs | (d) Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased under the plans or programs | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
July 1, 2012 to July 31, 2012 | — | $ | — | — | $ | — | ||||||||||||
August 1, 2012 to August 31, 2012 | — | — | — | — | ||||||||||||||
September 1, 2012 to September 30, 2012 | 82,470 | 2.87 | — | — | ||||||||||||||
Total | 82,470 | $ | 2.87 | — | $ | — |
(a) | These shares were not purchased as part of publicly announced plans or programs. They represent the surrender of shares to us to satisfy employee withholding tax obligations related to the vesting of stock-based compensation awards. |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2007 | 2008 | 2009 | 2010 | 2011 | 2008 | 2009 | 2010 | 2011 | 2012 | |||||||||||||||||||||||||||||||||||||||||
(In thousands, except share and per share amounts) | (In thousands, except share and per share amounts) | |||||||||||||||||||||||||||||||||||||||||||||||||
Statement of operations data: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Research and development | 15,939 | 32,554 | 32,325 | 26,177 | 13,901 | 32,554 | 32,325 | 26,177 | 13,901 | 12,571 | ||||||||||||||||||||||||||||||||||||||||
Government grants | — | — | — | — | (88 | ) | ||||||||||||||||||||||||||||||||||||||||||||
General and administrative | 8,386 | 14,800 | 10,994 | 10,980 | 9,321 | 14,800 | 10,994 | 10,980 | 9,321 | 6,816 | ||||||||||||||||||||||||||||||||||||||||
Total operating expenses | 24,325 | 47,354 | 43,319 | 37,157 | 23,222 | 47,354 | 43,319 | 37,157 | 23,222 | 19,299 | ||||||||||||||||||||||||||||||||||||||||
Other (income) and expense: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Interest and other income | (1,902 | ) | (3,010 | ) | (386 | ) | (17 | ) | (60 | ) | (3,010 | ) | (386 | ) | (17 | ) | (60 | ) | (80 | ) | ||||||||||||||||||||||||||||||
Adjustment to fair value of common stock warrant liability | — | — | — | 1,254 | (12,611 | ) | — | — | 1,254 | (12,611 | ) | 1,510 | ||||||||||||||||||||||||||||||||||||||
Loss before tax provision (benefit) | (22,423 | ) | (44,344 | ) | (42,933 | ) | (38,394 | ) | (10,551 | ) | (44,344 | ) | (42,933 | ) | (38,394 | ) | (10,551 | ) | (20,729 | ) | ||||||||||||||||||||||||||||||
Tax provision (benefit) | 125 | (983 | ) | 337 | (104 | ) | 41 | (983 | ) | 337 | (104 | ) | 41 | 18 | ||||||||||||||||||||||||||||||||||||
Net loss | (22,548 | ) | (43,361 | ) | (43,270 | ) | (38,290 | ) | (10,592 | ) | (43,361 | ) | (43,270 | ) | (38,290 | ) | (10,592 | ) | (20,747 | ) | ||||||||||||||||||||||||||||||
Deemed dividend — warrants | (4,457 | ) | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||
Net loss applicable to common stockholders | $ | (27,005 | ) | $ | (43,361 | ) | $ | (43,270 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (43,361 | ) | $ | (43,270 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (20,747 | ) | ||||||||||||||||||||
Net loss per share — basic and diluted | $ | (1.76 | ) | $ | (1.94 | ) | $ | (1.82 | ) | $ | (1.58 | ) | $ | (0.34 | ) | |||||||||||||||||||||||||||||||||||
Weighted average shares outstanding — basic and diluted | 15,354,898 | 22,390,434 | 23,746,598 | 24,161,866 | 31,154,962 | |||||||||||||||||||||||||||||||||||||||||||||
As of September 30, | ||||||||||||||||||||||||||||||||||||||||||||||||||
2007 | 2008 | 2009 | 2010 | 2011 | ||||||||||||||||||||||||||||||||||||||||||||||
(In thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||||
Balance sheet data: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 80,022 | $ | 90,283 | $ | 54,640 | $ | 28,923 | $ | 38,701 | ||||||||||||||||||||||||||||||||||||||||
Working capital | 75,244 | 84,377 | 46,787 | 25,178 | 35,907 | |||||||||||||||||||||||||||||||||||||||||||||
Total assets | 82,506 | 97,511 | 59,625 | 32,616 | 41,505 | |||||||||||||||||||||||||||||||||||||||||||||
Deficit accumulated during the development stage | (39,833 | ) | (83,194 | ) | (126,464 | ) | (164,754 | ) | (175,346 | ) | ||||||||||||||||||||||||||||||||||||||||
Total stockholders’ equity | 77,223 | 88,487 | 50,538 | 24,060 | 37,078 | |||||||||||||||||||||||||||||||||||||||||||||
Net loss per share — basic and diluted* | $ | (7.76 | ) | $ | (7.28 | ) | $ | (6.34 | ) | $ | (1.36 | ) | $ | (1.91 | ) | |||||||||||||||||||||||||||||||||||
Weighted average shares outstanding — basic and diluted* | 5,597,609 | 5,936,650 | 6,040,467 | 7,788,741 | 10,882,688 |
As of September 30, | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2008 | 2009 | 2010 | 2011 | 2012 | |||||||||||||||||||
(In thousands) | |||||||||||||||||||||||
Balance sheet data: | |||||||||||||||||||||||
Cash, cash equivalents, and marketable securities | $ | 90,283 | $ | 54,640 | $ | 28,923 | $ | 38,701 | $ | 39,050 | |||||||||||||
Working capital | 84,377 | 46,787 | 25,178 | 35,907 | 36,756 | ||||||||||||||||||
Total assets | 97,511 | 59,625 | 32,616 | 41,505 | 41,134 | ||||||||||||||||||
Deficit accumulated during the development stage | (83,194 | ) | (126,464 | ) | (164,754 | ) | (175,346 | ) | (196,093 | ) | |||||||||||||
Total stockholders’ equity | 88,487 | 50,538 | 24,060 | 37,078 | 31,016 |
* | Restated for a one for four (1:4) reverse stock split effective on June 11, 2012. |
ITEM 7. | MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
• | 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. |
• | study BIOD-123 in a Phase 2 clinical trial; |
• | study our ultra-rapid-acting insulin analog-based formulations in early stage clinical trials and conduct additional formulation development work to improve the stability, pharmacokinetic, and pharmacodynamic properties of our ultra-rapid-acting insulin analog-based formulations; and |
• | conduct the development work necessary to select a lead formulation for our liquid glucagon rescue product candidate and commence clinical trials of that formulation. |
• | conduct |
• | purchase |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | December 3, 2003 (Inception) to September 30, 2011 | 2010 | 2011 | 2012 | December 3, 2003 (Inception) to September 30, 2012 | |||||||||||||||||||||||||||||
(In thousands) | (In thousands) | |||||||||||||||||||||||||||||||||||
Research and development expenses: | ||||||||||||||||||||||||||||||||||||
Preclinical expenses | $ | 2,709 | $ | 2,746 | $ | 3,665 | $ | 18,665 | $ | 2,746 | $ | 3,665 | $ | 3,974 | $ | 22,639 | ||||||||||||||||||||
Manufacturing expenses | 11,674 | 8,894 | 5,332 | 36,287 | 8,894 | 5,332 | 2,644 | 38,931 | ||||||||||||||||||||||||||||
Clinical/regulatory expenses | 17,942 | 14,537 | 4,904 | 75,177 | 14,537 | 4,904 | 5,953 | 81,130 | ||||||||||||||||||||||||||||
Total | $ | 32,325 | $ | 26,177 | $ | 13,901 | $ | 130,129 | $ | 26,177 | $ | 13,901 | $ | 12,571 | $ | 142,700 |
• | our ability to complete our Phase 2 clinical trial of BIOD-123 in a timely manner and the outcome of that trial; |
• | the success of our formulation development work to improve the stability, pharmacokinetic and pharmacodynamic characteristics of our ultra-rapid-acting insulin analog-based formulations; |
• | our ability to conduct the development work necessary to select a lead formulation for our liquid glucagon product candidate for the rescue treatment of severe hypoglycemia and commence clinical trials of that formulation; |
• | the results of our real-time stability programs for our insulin and glucagon product candidates, |
• | our ability to accurately anticipate technical challenges that |
• | our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA; |
• |
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a |
• | our ability to |
• |
• | our ability to protect our intellectual property and operate our business without infringing upon the |
• | 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; |
• | the emergence of competing technologies and products and other adverse market |
• | the ability of our major suppliers to produce our products in our final dosage form; |
• | our commercialization, marketing and manufacturing capabilities and strategies; and |
• | our ability to |
• | fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials; |
• | fees paid to investigative sites in connection with clinical trials; |
• | fees paid to contract manufacturers in connection with the production of clinical trial materials; and |
• | professional service fees. |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Research and Development | $ | 13,901 | $ | 12,571 | $ | 1,330 | 10 | % | |||||||||||
Percentage of net loss | 131.2 | % | 60.6 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
General and Administrative | $ | 9,321 | $ | 6,816 | $ | 2,505 | 27 | % | |||||||||||
Percentage of net loss | 88.0 | % | 32.9 | % |
Year Ended September 30, | Increase | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Interest and Other Income | $ | 60 | $ | 80 | $ | 20 | 33 | % | |||||||||||
Percentage of net loss | 0.57 | % | 0.39 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Adjustments to fair value of common stock warrant liability | $ | (12,611 | ) | $ | 1,510 | $ | 14,121 | 112 | % | ||||||||||
Percentage of net loss | 119 | % | 7 | % |
Year Ended September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | Net change | |||||||||||||
Warrant: | |||||||||||||||
August 2011 | $ | (4,169 | ) | $ | — | $ | 4,169 | ||||||||
May 2011 | (8,442 | ) | 709 | 9,151 | |||||||||||
June 2012 | — | 801 | 801 | ||||||||||||
Total | $ | (12,611 | ) | $ | 1,510 | $ | 14,121 |
Year Ended September 30, | Increase | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Net loss | $ | (10,592 | ) | $ | (20,747 | ) | $ | 10,155 | 96 | % | |||||||||
Net loss per share | $ | (1.36 | ) | $ | (1.91 | ) |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Research and Development | $ | 26,177 | $ | 13,901 | $ | 12,276 | 46.9 | % | |||||||||||
Percentage of net loss | 68.4 | % | 131.2 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
General and Administrative | $ | 10,980 | $ | 9,321 | $ | 1,659 | 15 | % | |||||||||||
Percentage of net loss | 28.7 | % | 88 | % |
Year Ended September 30, | Increase | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Interest and Other Income | $ | 17 | $ | 60 | $ | 43 | 253 | % | |||||||||||
Percentage of net loss | 0.04 | % | 0.57 | % |
Year Ended September 30, | Decrease | Year Ended September 30, | Increase | |||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | $ | % | 2010 | 2011 | $ | % | |||||||||||||||||||||||||||||||
In thousands, except per share amounts | In thousands, except per share amounts | |||||||||||||||||||||||||||||||||||||
Adjustments to fair value of common stock warrant liability | $ | 1,254 | $ | (12,611 | ) | $ | 13,865 | 1,106 | % | $ | 1,254 | $ | (12,611 | ) | $ | 13,865 | 1,106 | % | ||||||||||||||||||||
Percentage of net loss | 3.3 | % | 119 | % | 3.3 | % | 119 | % |
Year Ended September 30, | Decrease | Year Ended September 30, | Decrease | |||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | $ | % | 2010 | 2011 | $ | % | |||||||||||||||||||||||||||||||
In thousands, except per share amounts | In thousands, except per share amounts | |||||||||||||||||||||||||||||||||||||
Net loss | $ | (38,290 | ) | $ | (10,592 | ) | $ | 27,698 | 72.3 | % | $ | (38,290 | ) | $ | (10,592 | ) | $ | 27,698 | 72.3 | % | ||||||||||||||||||
Net loss per share | $ | (1.58 | ) | $ | (0.34 | ) | $ | (6.34 | ) | $ | (1.36 | ) |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Research and Development | $ | 32,325 | $ | 26,177 | $ | 6,148 | 19.0 | % | |||||||||||
Percentage of net loss | 74.7 | % | 68.4 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
General and Administrative | $ | 10,994 | $ | 10,980 | $ | 14 | 0.1 | % | |||||||||||
Percentage of net loss | 25.5 | % | 28.7 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Interest and Other Income | $ | 386 | $ | 17 | $ | 369 | 95.6 | % | |||||||||||
Percentage of net loss | 0.9 | % | 0.04 | % |
Year Ended September 30, | Increase | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Adjustments to fair value of common stock warrant liability | $ | — | $ | 1,254 | $ | 1,254 | 100 | % | |||||||||||
Percentage of net loss | —% | 3.3 | % |
Year Ended September 30, | Decrease | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | $ | % | ||||||||||||||||
In thousands, except per share amounts | |||||||||||||||||||
Net loss | $ | (43,270 | ) | $ | (38,290 | ) | $ | 4,980 | 11.5 | % | |||||||||
Net loss per share | $ | (1.82 | ) | $ | (1.58 | ) |
• | the progress, timing or success of our research and development and clinical programs for our product candidates, |
• | our |
• | the success of our formulation development work to improve the stability, pharmacokinetic and pharmacodynamic characteristics of our ultra-rapid-acting insulin analog-based formulations; |
• | our ability to conduct the formulation development work necessary to select a commercial candidate formulation for our glucagon rescue product for the treatment of severe hypoglycemia and commence clinical trials of that |
• | the results of our real-time stability programs for our insulin and glucagon product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to |
• | our ability to |
• | our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA; |
• |
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a |
• | 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 degree of clinical utility of our |
• | the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation; |
• | the ability of our major suppliers to produce our products in our final dosage form; |
• | our commercialization, marketing and manufacturing capabilities and strategies; and |
• | our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing. |
Total | Less Than 1 Year | 1-3 Years | 5 Years | More Than 5 Years | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Operating lease obligations | $ | 1,780 | $ | 689 | $ | 1,091 | $ | — | $ | — | ||||||||||||
Purchase commitments | 20,923 | — | 1,119 | 9,792 | 10,012 | |||||||||||||||||
Total fixed contractual obligations | $ | 22,703 | $ | 689 | $ | 2,210 | $ | 9,792 | $ | 10,012 |
ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL |
• | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company; |
• | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and |
expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and |
• | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements. |
ITEM 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS |
BIODEL INC. | ||||||||||
By: | /s/ ERROL DE SOUZA | |||||||||
Dr. Errol De Souza President and Chief Executive Officer Date: December |
Signature | Title | Date | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
/s/ ERROL DE SOUZA Errol De Souza | President and Chief Executive Officer (Principal Executive Officer), Director | December | ||||||||
/s/ GERARD J. MICHEL Gerard J. Michel | Chief Financial Officer, Vice President, Corporate Development and Treasurer (Principal Financial and Accounting Officer) | December | ||||||||
/s/ | Director | December | ||||||||
/s/ BARRY H. GINSBERG Barry H. Ginsberg | Director | December | ||||||||
/s/ IRA W. LIEBERMAN Ira W. Lieberman | Director | December | ||||||||
/s/ DANIEL LORBER Daniel Lorber | Director | December | ||||||||
/s/ BRIAN J.G. PEREIRA Brian J.G. Pereira | Director | December | ||||||||
/s/ | Director | December |
Exhibit Number | Description of Document | |||||
---|---|---|---|---|---|---|
3.1 | Registrant’s Second Amended and Restated Certificate of Incorporation (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
3.2 | ||||||
Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to exhibit 4.6 to the Registrant’s Current Report on Form 8-K filed on May 19, 2011). | ||||||
3.3 | Certificate of Amendment to Registrant’s Second Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 11, 2012). | |||||
3.4 | Certificate of Designation of Series B Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 4.8 to the Registrant’s Current Report on Form 8-K filed on June 27, 2012). | |||||
3.5 | Certificate of Amendment of Registrant’s Second Amended and Restated Certificate of Incorporation, as amended. | |||||
3.6 | Registrant’s Amended and Restated Bylaws (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
4.1 | Specimen Common Stock Certificate (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
4.2 | ||||||
Form of Warrant to Purchase Shares of Common Stock issued in the Registrant’s May 2011 registered direct offering (Incorporated by reference to exhibit 4.7 to the Registrant’s Current Report on Form 8-K filed on May 13, 2011). | ||||||
4.3 | Form of Warrant issued in the Registrant’s June 2012 private placement (Incorporated by reference to | |||||
10.1 | 2010 Stock Incentive Plan, as amended March 8, 2012 (Incorporated by reference to Exhibit A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on January 26, 2012). | |||||
10.2 | 2010 Incentive Stock Option Agreement (Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q filed on May 7, 2010). | |||||
10.3 | 2010 Non Statutory Stock Option Agreement (Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q filed on May 7, 2010). | |||||
10.4 | 2010 Restricted Stock Unit Agreement (Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q filed on May 7, 2010). | |||||
10.5 | Form of Indemnity Agreement entered into between the Registrant and its directors and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.6 | Amended and Restated 2004 Stock Incentive Plan (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.7 | 2005 Employee Stock Purchase Plan (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.8 | 2005 Non-Employee Directors’ Stock Option Plan (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.9 | ||||||
Employment Agreement, dated March 26, 2010, between the Registrant and Errol B. De Souza (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 1, 2010). |
Exhibit Number | Description of Document | |||||
---|---|---|---|---|---|---|
10.10 | ||||||
Change of Control Agreement entered into between the Registrant and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | ||||||
10.11 | Executive Severance Agreement entered into between the Registrant and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.12 | Lease Agreement, dated February 2, 2004, between the Registrant and Mulvaney Properties, LLC and amendment thereto dated September 29, 2006 (Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (333-140504)). | |||||
10.13 | Commercial Lease, dated July 23, 2007, by and between the Registrant and Mulvaney Properties LLC. (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 27, 2007). | |||||
10.14 | Lease Amendment, dated October 1, 2007, between the Registrant and Mulvaney Properties LLC (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 4, 2007). | |||||
10.15 | Amendment to Lease Agreement, dated February 2, 2004, as amended, by and between the Registrant and Mulvaney Properties LLC. (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 27, 2007). | |||||
10.16 | Offer Letter, dated November 12, 2007, by and between the Registrant and Gerard J. Michel. (Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on November 14, 2007). | |||||
10.17 | Form of Incentive Stock Option Agreement for 2004 Amended and Restated Stock Incentive Plan. (Incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on December 21, 2007). | |||||
10.18 | Form of Option Agreement for 2005 Non-Employee Directors’ Stock Option Plan. (Incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on December 21, 2007). | |||||
10.19 | Base salaries of Executive Officers of the Registrant. | |||||
10.20 | Summary of the Registrant’s Non-Employee Director Compensation. | |||||
10.21† | Supply Agreement, dated July 7, 2008, between the Registrant and N.V. Organon (Incorporated by reference to exhibit 10.3 the Registrant’s Quarterly Report on Form 10-Q filed on August 11, 2008). | |||||
10.22† | Letter Agreement, dated November 12, 2009, between the Registrant and N.V. Organon, amending the Supply Agreement, dated July 7, 2008, between the parties. (Incorporated by reference to exhibit 10.22 to Registrant’s Annual Report on Form 10-K filed on December 14, 2009). | |||||
10.23† | Letter Agreement, dated July 25, 2011, between the Registrant and N.V. Organon amending the Supply Agreement dated July 7, | |||||
10.24† | License Agreement, effective as of June 8, 2012, between Aegis Therapeutics, LLC and the Registrant (Incorporated by reference to Exhibit 10.01 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 filed on August 14, 2012). | |||||
10.25 | Securities Purchase Agreement, dated as of June 21, 2012, among the Registrant and the purchasers named therein (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 21, 2012). | |||||
21.1 | Subsidiaries of the Registrant. |
Exhibit Number | Description of Document | |||||
---|---|---|---|---|---|---|
23.1 | ||||||
Consent of BDO USA, LLP, Independent Registered Public Accounting Firm. | ||||||
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.INS | XBRL Instance Document.* | |||||
101.SCH | XBRL Taxonomy Extension Schema Document.* | |||||
101.CAL | XBRL Taxonomy Calculation Linkbase Document.* | |||||
101.LAB | XBRL Taxonomy Label Linkbase Document.* | |||||
101.PRE | XBRL Taxonomy Presentation Linkbase Document.* | |||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. |
† | Confidential treatment granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission. |
* |
submitted electronically herewith |
Page | ||||||
---|---|---|---|---|---|---|
Report of independent registered public accounting firm | F-2 | |||||
Balance sheets | F-3 | |||||
Statements of operations | F-4 | |||||
Statements of stockholders’ equity | F-5 | |||||
Statements of comprehensive loss | F-7 | |||||
Statements of cash flows | F-8 | |||||
Notes to financial statements |
September 30, | September 30, | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2011 | 2012 | |||||||||||||||||||
ASSETS | ASSETS | ASSETS | ||||||||||||||||||||
Current: | ||||||||||||||||||||||
Cash and cash equivalents | $ | 22,922 | $ | 38,701 | $ | 38,701 | $ | 39,050 | ||||||||||||||
Restricted cash | 150 | 60 | 60 | 60 | ||||||||||||||||||
Marketable securities, available for sale | 6,001 | — | ||||||||||||||||||||
Taxes receivable | 116 | 35 | 35 | 34 | ||||||||||||||||||
Grant receivable | — | 88 | ||||||||||||||||||||
Other receivable | 11 | 1 | 1 | 9 | ||||||||||||||||||
Prepaid and other assets | 365 | 399 | 399 | 295 | ||||||||||||||||||
Total current assets | 29,565 | 39,196 | 39,196 | 39,536 | ||||||||||||||||||
Property and equipment, net | 2,998 | 2,253 | 2,253 | 1,552 | ||||||||||||||||||
Intellectual property, net | 53 | 49 | 49 | 46 | ||||||||||||||||||
Long term other assets | — | 7 | 7 | — | ||||||||||||||||||
Total assets | $ | 32,616 | $ | 41,505 | $ | 41,505 | $ | 41,134 | ||||||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | LIABILITIES AND STOCKHOLDERS’ EQUITY | LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||||||||
Current: | ||||||||||||||||||||||
Accounts payable | $ | 1,989 | $ | 222 | $ | 222 | $ | 285 | ||||||||||||||
Accrued expenses: | ||||||||||||||||||||||
Clinical trial expenses | 1,362 | 763 | 763 | 488 | ||||||||||||||||||
Payroll and related | 357 | 1,118 | 1,118 | 1,248 | ||||||||||||||||||
Accounting and legal fees | 300 | 191 | 191 | 244 | ||||||||||||||||||
Severance | — | 688 | 688 | 141 | ||||||||||||||||||
Other | 334 | 204 | 204 | 273 | ||||||||||||||||||
Income taxes payable | 45 | 103 | 103 | 101 | ||||||||||||||||||
Total current liabilities | 4,387 | 3,289 | 3,289 | 2,780 | ||||||||||||||||||
Common stock warrant liability | 4,169 | 996 | 996 | 7,338 | ||||||||||||||||||
Severance payable, long term portion | — | 142 | 142 | — | ||||||||||||||||||
Total liabilities | 8,556 | 4,427 | 4,427 | 10,118 | ||||||||||||||||||
Commitments | ||||||||||||||||||||||
Stockholders’ equity: | ||||||||||||||||||||||
Convertible preferred stock, $.01 par value; 50,000,000 shares authorized, none and 1,813,944 issued and outstanding | — | 18 | ||||||||||||||||||||
Common stock, $.01 par value; 100,000,000 shares authorized; 26,399,764 and 38,647,683 issued and outstanding | 264 | 386 | ||||||||||||||||||||
Convertible preferred stock, $.01 par value; 50,000,000 shares authorized, 1,813,944 and 5,419,551 issued and outstanding | 18 | 54 | ||||||||||||||||||||
Common stock, $.01 par value; 25,000,000 shares authorized; 9,661,868 and 14,174,545 issued and outstanding | 96 | 142 | ||||||||||||||||||||
Additional paid-in capital | 188,549 | 212,020 | 212,310 | 226,913 | ||||||||||||||||||
Accumulated other comprehensive loss | 1 | — | ||||||||||||||||||||
Deficit accumulated during the development stage | (164,754 | ) | (175,346 | ) | (175,346 | ) | (196,093 | ) | ||||||||||||||
Total stockholders’ equity | 24,060 | 37,078 | 37,078 | 31,016 | ||||||||||||||||||
Total liabilities and stockholders’ equity | $ | 32,616 | $ | 41,505 | $ | 41,505 | $ | 41,134 |
Year Ended September 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | December 3, 2003 (Inception) to September 30, 2011 | |||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 32,325 | 26,177 | 13,901 | 130,129 | ||||||||||||||
General and administrative | 10,994 | 10,980 | 9,321 | 56,946 | ||||||||||||||
Total operating expenses | 43,319 | 37,157 | 23,222 | 187,075 | ||||||||||||||
Other (income) and expense: | ||||||||||||||||||
Interest and other income | (386 | ) | (17 | ) | (60 | ) | (5,566 | ) | ||||||||||
Interest expense | — | — | — | 78 | ||||||||||||||
Adjustments to fair value of common stock warrant liability | — | 1,254 | (12,611 | ) | (11,357 | ) | ||||||||||||
Loss on settlement of debt | — | — | — | 627 | ||||||||||||||
Loss before tax provision (benefit) | (42,933 | ) | (38,394 | ) | (10,551 | ) | (170,857 | ) | ||||||||||
Tax provision (benefit) | 337 | (104 | ) | 41 | (571 | ) | ||||||||||||
Net loss | (43,270 | ) | (38,290 | ) | (10,592 | ) | (170,286 | ) | ||||||||||
Charge for accretion of beneficial conversion rights | — | — | — | (603 | ) | |||||||||||||
Deemed dividend — warrants | — | — | — | (4,457 | ) | |||||||||||||
Net loss applicable to common stockholders | $ | (43,270 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (175,346 | ) | ||||||
Net loss per share — basic and diluted | $ | (1.82 | ) | $ | (1.58 | ) | $ | (0.34 | ) | |||||||||
Weighted average shares outstanding — basic and diluted | 23,746,598 | 24,161,866 | 31,154,962 |
Year Ended September 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2012 | December 3, 2003 (Inception) to September 30, 2012 | |||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 26,177 | 13,901 | 12,571 | 142,700 | ||||||||||||||
Government grants | — | — | (88 | ) | (88 | ) | ||||||||||||
General and administrative | 10,980 | 9,321 | 6,816 | 63,762 | ||||||||||||||
Total operating expenses | 37,157 | 23,222 | 19,299 | 206,374 | ||||||||||||||
Other (income) and expense: | ||||||||||||||||||
Interest and other income | (17 | ) | (60 | ) | (80 | ) | (5,646 | ) | ||||||||||
Interest expense | — | — | — | 78 | ||||||||||||||
Adjustments to fair value of common stock warrant liability | 1,254 | (12,611 | ) | 1,510 | (9,847 | ) | ||||||||||||
Loss on settlement of debt | — | — | — | 627 | ||||||||||||||
Loss before tax provision (benefit) | (38,394 | ) | (10,551 | ) | (20,729 | ) | (191,586 | ) | ||||||||||
Tax provision (benefit) | (104 | ) | 41 | 18 | (553 | ) | ||||||||||||
Net loss | (38,290 | ) | (10,592 | ) | (20,747 | ) | (191,033 | ) | ||||||||||
Charge for accretion of beneficial conversion rights | — | — | — | (603 | ) | |||||||||||||
Deemed dividend — warrants | — | — | — | (4,457 | ) | |||||||||||||
Net loss applicable to common stockholders | $ | (38,290 | ) | $ | (10,592 | ) | $ | (20,747 | ) | $ | (196,093 | ) | ||||||
Net loss per share — basic and diluted* | $ | (6.34 | ) | $ | (1.36 | ) | $ | (1.91 | ) | |||||||||
Weighted average shares outstanding — basic and diluted* | 6,040,467 | 7,788,741 | 10,882,688 |
* | Restated for a one for four (1:4) reverse stock split effective on June 11, 2012. |
Common Stock $01 Par Value | Series A Convertible Preferred stock $.01 Par Value | Series B Convertible Preferred stock $.01 Par Value | Common Stock $01 Par Value | Series A Preferred stock $.01 Par Value | Series B Preferred stock $.01 Par Value | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated Other Comprehensive Income (loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated Other Comprehensive Income (loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
December 3, 2003 (inception) | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Inception (December 3, 2003) | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares issued to employees | 732,504 | 7 | — | — | — | — | (7 | ) | — | — | 183,126 | 2 | — | — | — | — | (2 | ) | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
January 2004 Proceeds from sale of common stock | 4,581,240 | 46 | — | — | — | — | 1,308 | — | 1,354 | 1,145,306 | 11 | — | — | — | — | 1,343 | — | — | 1,354 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (774 | ) | (774 | ) | — | — | — | — | — | — | — | — | (774 | ) | (774 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2004 | 5,313,744 | 53 | — | — | — | — | 1,301 | — | (774 | ) | 580 | 1,328,432 | $ | 13 | — | $ | — | — | $ | — | $ | 1,341 | $ | — | $ | (774 | ) | $ | 580 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Additional stockholder contributions | — | — | — | — | — | — | 514 | — | 514 | — | — | — | — | — | — | 514 | — | — | 514 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 353 | — | 353 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 353 | — | — | 353 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares issued to employees and directors for services | 42,656 | 1 | — | — | — | — | 60 | — | 61 | 10,658 | — | — | — | — | — | 61 | — | — | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
July 2005 Private placement — Sale of Series A preferred stock, net of issuance costs of $379 | — | — | 569,000 | 6 | — | — | 2,460 | — | 2,466 | — | — | 569,000 | 6 | — | — | 2,460 | — | — | 2,466 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Founder’s compensation contributed to capital | — | — | — | — | — | — | 63 | — | 63 | — | — | — | — | — | — | 63 | — | — | 63 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (3,383 | ) | (3,383 | ) | — | — | — | — | — | — | — | — | (3,383 | ) | (3,383 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2005 | 5,356,400 | 54 | 569,000 | 6 | — | — | 4,751 | — | (4,157 | ) | 654 | 1,339,090 | $ | 13 | 569,000 | $ | 6 | — | $ | — | $ | 4,792 | $ | — | $ | (4,157 | ) | $ | 654 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 1,132 | — | 1,132 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 1,132 | — | — | 1,132 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
July 2006 Private placement — Sale of Series B preferred stock, net of issuance costs of $1,795 | — | — | — | — | 5,380,711 | 54 | 19,351 | — | 19,405 | — | — | — | — | 5,380,711 | 54 | 19,351 | — | — | 19,405 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
July 2006 — Series B preferred stock units issued July 2006 to settle debt | — | — | — | — | 817,468 | 8 | 3,194 | — | 3,202 | — | — | — | — | 817,468 | 8 | 3,194 | — | — | 3,202 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares issued to employees and directors for services | 4,030 | — | — | — | — | — | 23 | — | 23 | 988 | — | — | — | — | — | 23 | — | — | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accretion of fair value of beneficial conversion charge | — | — | — | — | — | — | 603 | (603 | ) | — | — | — | — | — | — | — | 603 | — | (603 | ) | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (8,068 | ) | (8,068 | ) | — | — | — | — | — | — | — | — | (8,068 | ) | (8,068 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2006 | 5,360,430 | 54 | 569,000 | 6 | 6,198,179 | 62 | 29,054 | — | (12,828 | ) | 16,348 | 1,340,078 | $ | 13 | 569,000 | $ | 6 | 6,198,179 | $ | 62 | $ | 29,095 | $ | — | $ | (12,828 | ) | $ | 16,348 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
May 2007 Proceeds from sale of common stock | 5,750,000 | 58 | — | — | — | — | 78,697 | — | 78,755 | 1,437,500 | 14 | — | — | — | — | 78,741 | — | — | 78,755 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Conversion of preferred stock on May 16, 2007 | 6,407,008 | 64 | (569,000 | ) | (6 | ) | (6,198,179 | ) | (62 | ) | 4 | — | — | 1,601,749 | 16 | (569,000 | ) | (6 | ) | (6,198,179 | ) | (62 | ) | 52 | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 4,224 | — | 4,224 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 4,224 | — | — | 4,224 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares issued to employees, non-employees and directors for services | 2,949 | — | — | — | — | — | 16 | — | 16 | 732 | — | — | — | — | — | 16 | — | — | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | 3,542 | — | — | — | — | — | 5 | — | 5 | 885 | — | — | — | — | — | 5 | — | — | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
March 2007 Warrants exercised | 2,636,907 | 26 | — | — | — | — | 397 | — | 423 | 659,226 | 7 | — | — | — | — | 416 | — | — | 423 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deemed dividend — warrants | — | — | — | — | — | — | 4,457 | (4,457 | ) | — | — | — | — | — | — | — | 4,457 | — | (4,457 | ) | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (22,548 | ) | (22,548 | ) | — | — | — | — | — | — | — | — | (22,548 | ) | (22,548 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2007 | 20,160,836 | 202 | — | — | — | — | 116,854 | — | (39,833 | ) | 77,223 | 5,040,170 | $ | 50 | — | $ | — | — | $ | — | $ | 117,006 | $ | — | $ | (39,833 | ) | $ | 77,223 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from sale of common stock | 3,260,000 | 32 | — | — | — | — | 46,785 | — | 46,817 | 815,000 | 8 | — | — | — | — | 46,809 | — | — | 46,817 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of restricted stock | 9,714 | — | — | — | — | — | 172 | — | 172 | 2,428 | — | — | — | — | — | 172 | — | — | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 6,503 | — | 6,503 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 6,503 | — | — | 6,503 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | 174,410 | 1 | — | — | — | — | 901 | — | 902 | 43,600 | 1 | — | — | — | — | 901 | — | — | 902 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants exercised | 79,210 | 1 | — | — | — | — | 111 | — | 112 | 19,802 | — | — | — | — | — | 112 | — | — | 112 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized (loss) on Marketable Securities | — | — | — | — | — | — | — | (62 | ) | — | (62 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized loss on Marketable Securities | — | — | — | — | — | — | — | (62 | ) | — | (62 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from sale of stock — ESPP | 14,388 | 1 | — | — | — | — | 180 | — | 181 | 3,596 | — | — | — | — | — | 181 | — | — | 181 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (43,361 | ) | (43,361 | ) | — | — | — | — | — | — | — | — | (43,361 | ) | (43,361 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2008 | 23,698,558 | $ | 237 | — | $ | — | — | $ | — | $ | 171,506 | $ | (62 | ) | $ | (83,194 | ) | $ | 88,487 | 5,924,596 | $ | 59 | — | $ | — | — | — | $ | 171,684 | $ | (62 | ) | $ | (83,194 | ) | $ | 88,487 | |||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 5,064 | — | — | 5,064 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 5,064 | — | — | 5,064 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | 17,661 | — | — | — | — | — | 25 | — | — | 25 | 4,413 | — | — | — | — | — | 25 | — | — | 25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized gain on Marketable Securities | — | — | — | — | — | — | — | 62 | — | 62 | — | — | — | — | — | — | — | 62 | — | 62 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from sale of stock — ESPP | 87,453 | 1 | — | — | — | — | 169 | — | — | 170 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from the sale of stock — ESPP | 21,863 | — | — | — | — | — | 170 | — | — | 170 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (43,270 | ) | (43,270 | ) | (43,270 | ) | (43,270 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2009 | 23,803,672 | $ | 238 | — | $ | — | — | $ | — | $ | 176,764 | $ | — | $ | (126,464 | ) | $ | 50,538 | 5,950,872 | $ | 59 | — | $ | — | — | $ | — | $ | 176,943 | $ | — | $ | (126,464 | ) | $ | 50,538 | ||||||||||||||||||||||||||||||||||||||||||||||||
Registered direct offering | 2,398,200 | 24 | — | — | — | — | 8,688 | — | — | 8,712 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Initial value of warrants issued in a registered direct offering | — | — | — | — | — | — | (2,915 | ) | — | — | (2,915 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 5,621 | — | — | 5,621 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Registered direct financing | 599,550 | 6 | — | — | — | — | 8,706 | — | — | 8,712 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Initial value of warrants issued in a registered direct | — | — | — | — | — | — | (2,915 | ) | — | — | (2,915 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 5,621 | — | — | 5,621 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | 32,320 | — | — | — | — | — | 68 | — | — | 68 | 8,076 | — | — | — | — | — | 68 | — | — | 68 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized gain on Marketable Securities | — | — | — | — | — | — | 1 | — | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from sale of stock — ESPP | 165,572 | 2 | — | — | — | — | 323 | — | — | 325 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | — | — | — | — | 1 | — | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from the sale of stock — ESPP | 41,393 | 1 | — | — | — | — | 324 | �� | — | — | 325 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (38,290 | ) | (38,290 | ) | — | — | — | — | — | — | — | — | (38,290 | ) | (38,290 | ) |
Common Stock $01 Par Value | Series A Convertible Preferred stock $.01 Par Value | Series B Convertible Preferred stock $.01 Par Value | Common Stock $01 Par Value | Series A Preferred stock $.01 Par Value | Series B Preferred stock $.01 Par Value | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated Other Comprehensive Income (loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated Other Comprehensive Income (loss) | Deficit Accumulated During the Development Stage | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2010 | 26,399,764 | $ | 264 | — | $ | — | — | $ | — | $ | 188,549 | $ | 1 | $ | (164,754 | ) | $ | 24,060 | 6,599,891 | $ | 66 | — | $ | — | — | $ | — | $ | 188,747 | $ | 1 | $ | (164,754 | ) | $ | 24,060 | ||||||||||||||||||||||||||||||||||||||||||||||||
Registered direct financing | 12,074,945 | 121 | 1,813,944 | 18 | — | — | 27,822 | — | — | 27,961 | 3,018,736 | 30 | 1,813,944 | 18 | — | — | 27,913 | — | — | 27,961 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Initial value of warrants issued in a registered direct offering | — | — | — | — | — | — | (9,438 | ) | — | — | (9,438 | ) | — | — | — | — | — | — | (9,438 | ) | — | — | (9,438 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | 4,920 | — | — | 4,920 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 4,920 | — | — | 4,920 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | 417 | — | — | — | — | — | — | — | — | — | 104 | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants exercised | 42,200 | — | — | — | — | — | 50 | — | — | 50 | 10,549 | — | — | — | — | — | 50 | — | — | 50 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RSU’s granted | 62,149 | 1 | — | — | — | — | (1 | ) | — | — | — | 15,537 | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | — | — | — | — | (1 | ) | — | (1 | ) | — | — | — | — | — | — | — | (1 | ) | — | (1 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from sale of stock — ESPP | 68,208 | — | — | — | — | — | 118 | — | — | 118 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from the sale of stock — ESPP | 17,051 | — | — | — | — | — | 118 | — | — | 118 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (10,592 | ) | (10,592 | ) | — | — | — | — | — | — | — | — | (10,592 | ) | (10,592 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2011 | 38,647,683 | $ | 386 | 1,813,944 | $ | 18 | — | $ | — | $ | 212,020 | $ | — | $ | (175,346 | ) | $ | 37,078 | 9,661,868 | $ | 96 | 1,813,944 | $ | 18 | — | $ | — | $ | 212,310 | $ | — | $ | (175,346 | ) | $ | 37,078 | ||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from the sale of unregistered securities | 4,250,020 | 43 | — | — | 3,605,607 | 36 | 16,999 | — | — | 17,078 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Initial value of warrants issued in private placement financing | — | — | — | — | — | — | (4,832 | ) | — | — | (4,832 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | 1,828 | — | — | 1,828 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Proceeds from the sale of stock — ESPP | 10,776 | — | — | — | — | — | 27 | — | — | 27 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RSUs issued to settle bonus liability | 191,719 | 2 | — | — | — | — | 582 | — | — | 584 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RSUs granted | 60,409 | 1 | — | — | — | — | (1 | ) | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | (20,747 | ) | (20,747 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Company re-purchase of fractional shares from the reverse stock split | (247 | ) | — | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, Septermber 30, 2012 | 14,174,545 | $ | 142 | 1,813,944 | $ | 18 | 3,605,607 | $ | 36 | $ | 226,913 | $ | — | $ | (196,093 | ) | $ | 31,016 |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | 2010 | 2011 | 2012 | |||||||||||||||||||||||||
Net loss | $ | (43,270 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (20,747 | ) | ||||||||||||
Unrealized holding gains arising during the period | 62 | 1 | — | 1 | — | — | ||||||||||||||||||||||||
Comprehensive loss | $ | (43,208 | ) | $ | (38,289 | ) | $ | (10,592 | ) | $ | (38,289 | ) | $ | (10,592 | ) | $ | (20,747 | ) |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | December 3, 2003 (Inception) to September 30, 2011 | 2010 | 2011 | 2012 | December 3, 2003 (Inception) to September 30, 2012 | |||||||||||||||||||||||||||||
Cash flows from operating activities: | ||||||||||||||||||||||||||||||||||||
Net loss | $ | (43,270 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (170,286 | ) | $ | (38,290 | ) | $ | (10,592 | ) | $ | (20,747 | ) | $ | (191,033 | ) | ||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||||||||||||||||||
Depreciation and amortization | 877 | 991 | 938 | 4,078 | 991 | 938 | 725 | 4,803 | ||||||||||||||||||||||||||||
Founder’s compensation contributed to capital | — | — | — | 271 | — | — | — | 271 | ||||||||||||||||||||||||||||
Share-based compensation for employees and directors | 4,970 | 5,628 | 4,964 | 25,796 | 5,628 | 4,964 | 1,828 | 27,624 | ||||||||||||||||||||||||||||
Share-based compensation for non-employees | 94 | (7 | ) | (44 | ) | 2,274 | (7 | ) | (44 | ) | — | 2,274 | ||||||||||||||||||||||||
Loss on settlement of debt | — | — | — | 627 | — | — | — | 627 | ||||||||||||||||||||||||||||
Write-off of capitalized patent expense | — | — | — | 208 | — | — | 38 | 246 | ||||||||||||||||||||||||||||
Write-off of loan to related party | — | — | — | 41 | — | — | — | 41 | ||||||||||||||||||||||||||||
Adjustment to fair value of common stock warrant liability | — | 1,254 | (12,611 | ) | (11,357 | ) | 1,254 | (12,611 | ) | 1,510 | (9,847 | ) | ||||||||||||||||||||||||
(Increase) decrease in: | �� | |||||||||||||||||||||||||||||||||||
Prepaid expenses and other assets | 768 | 117 | (41 | ) | (406 | ) | 117 | (41 | ) | 111 | (295 | ) | ||||||||||||||||||||||||
Income taxes receivable | 1,236 | 636 | 81 | (35 | ) | 636 | 81 | 1 | (34 | ) | ||||||||||||||||||||||||||
Grant receivable | — | — | 88 | 88 | ||||||||||||||||||||||||||||||||
Other receivable | — | (11 | ) | 10 | (1 | ) | (11 | ) | 10 | (8 | ) | (9 | ) | |||||||||||||||||||||||
Increase (decrease) in: | ||||||||||||||||||||||||||||||||||||
Accounts payable | 194 | 982 | (1,767 | ) | 222 | 982 | (1,767 | ) | 63 | 285 | ||||||||||||||||||||||||||
Income tax payable | (847 | ) | (120 | ) | 58 | 103 | (120 | ) | 58 | (2 | ) | 101 | ||||||||||||||||||||||||
Accrued expenses and other liabilities | 715 | (5,561 | ) | 753 | 3,325 | (5,561 | ) | 753 | (128 | ) | 3,199 | |||||||||||||||||||||||||
Total adjustments | 8,007 | 3,909 | (7,659 | ) | 25,146 | 3,909 | (7,659 | ) | 4,052 | 29,198 | ||||||||||||||||||||||||||
Net cash used in operating activities | (35,263 | ) | (34,381 | ) | (18,251 | ) | (145,140 | ) | (34,381 | ) | (18,251 | ) | (16,695 | ) | (161,835 | ) | ||||||||||||||||||||
Cash flows from investing activities: | ||||||||||||||||||||||||||||||||||||
Purchase of property and equipment | (637 | ) | (292 | ) | (189 | ) | (6,290 | ) | (292 | ) | (189 | ) | (59 | ) | (6,349 | ) | ||||||||||||||||||||
Purchase of marketable securities | — | (6,000 | ) | — | (31,614 | ) | (6,000 | ) | — | — | (31,614 | ) | ||||||||||||||||||||||||
Sale of marketable securities | 25,614 | — | 6,000 | 31,614 | — | 6,000 | — | 31,614 | ||||||||||||||||||||||||||||
Capitalized intellectual properties | — | — | — | (298 | ) | — | — | — | (298 | ) | ||||||||||||||||||||||||||
Loan to related party | — | — | — | (41 | ) | — | — | — | (41 | ) | ||||||||||||||||||||||||||
Net cash provided by (used in) investing activities | 24,977 | (6,292 | ) | 5,811 | (6,629 | ) | ||||||||||||||||||||||||||||||
Net cash (used in) provided by investing activities | (6,292 | ) | 5,811 | (59 | ) | (6,688 | ) | |||||||||||||||||||||||||||||
Cash flows from financing activities: | ||||||||||||||||||||||||||||||||||||
Restricted cash | — | (150 | ) | 90 | (60 | ) | (150 | ) | 90 | — | (60 | ) | ||||||||||||||||||||||||
Options exercised | 25 | 68 | — | 1,000 | 68 | — | — | 1,000 | ||||||||||||||||||||||||||||
Warrants exercised | — | — | 50 | 585 | — | 50 | — | 585 | ||||||||||||||||||||||||||||
Net proceeds from employee stock purchase plan | 325 | 118 | 27 | 821 | ||||||||||||||||||||||||||||||||
Deferred public offering costs | — | — | — | (1,458 | ) | — | — | — | (1,458 | ) | ||||||||||||||||||||||||||
Stockholder contribution | — | — | — | 1,660 | — | — | — | 1,660 | ||||||||||||||||||||||||||||
Net proceeds from sale of Series A preferred stock 2005 | — | — | — | 2,466 | — | — | — | 2,466 | ||||||||||||||||||||||||||||
Net proceeds from sale of Series A preferred stock 2011 | — | — | 2,685 | 2,685 | — | 2,685 | — | 2,685 | ||||||||||||||||||||||||||||
Net proceeds from employee stock purchase plan | 170 | 325 | 118 | 794 | ||||||||||||||||||||||||||||||||
Net proceeds from sale of common stock | — | 8,712 | 25,276 | 161,018 | 8,712 | 25,276 | — | 161,018 | ||||||||||||||||||||||||||||
Proceeds from bridge financing | — | — | — | 2,575 | — | — | — | 2,575 | ||||||||||||||||||||||||||||
Net proceeds from sale of Series B preferred stock | — | — | — | 19,205 | ||||||||||||||||||||||||||||||||
Net proceeds from sale of Series B preferred stock 2006 | — | — | — | 19,205 | ||||||||||||||||||||||||||||||||
Net proceeds from sale of Series B preferred stock 2012 | — | — | 8,491 | 8,491 | ||||||||||||||||||||||||||||||||
Net proceeds from sale of unregistered common stock — private placement | — | — | 8,585 | 8,585 | ||||||||||||||||||||||||||||||||
Net cash provided by financing activities | 195 | 8,955 | 28,219 | 190,470 | 8,955 | 28,219 | 17,103 | 207,573 | ||||||||||||||||||||||||||||
Net increase (decrease) in cash and cash equivalents | (10,091 | ) | (31,718 | ) | 15,779 | 38,701 | ||||||||||||||||||||||||||||||
Net (decrease) increase in cash and cash equivalents | (31,718 | ) | 15,779 | 349 | 39,050 | |||||||||||||||||||||||||||||||
Cash and cash equivalents, beginning of period | 64,731 | 54,640 | 22,922 | — | 54,640 | 22,922 | 38,701 | — | ||||||||||||||||||||||||||||
Cash and cash equivalents, end of period | $ | 54,640 | $ | 22,922 | $ | 38,701 | $ | 38,701 | $ | 22,922 | $ | 38,701 | $ | 39,050 | $ | 39,050 | ||||||||||||||||||||
Cash paid for interest and income taxes was: | ||||||||||||||||||||||||||||||||||||
Interest | $ | — | $ | — | $ | — | $ | 9 | $ | — | $ | — | $ | — | $ | 9 | ||||||||||||||||||||
Income taxes | 111 | 60 | — | 306 | 60 | — | 20 | 326 | ||||||||||||||||||||||||||||
Non-cash financing and investing activities: | ||||||||||||||||||||||||||||||||||||
Warrants issued in connection with registered direct offering | $ | — | $ | 2,915 | $ | 9,438 | $ | 12,353 | ||||||||||||||||||||||||||||
Settlement of debt with Series B preferred stock | — | — | — | 3,202 | ||||||||||||||||||||||||||||||||
Accrued expenses settled with Series B preferred stock | — | — | — | 150 | ||||||||||||||||||||||||||||||||
Deemed dividend — warrants | — | — | — | 4,457 | ||||||||||||||||||||||||||||||||
Accretion of fair value of beneficial charge on preferred stock | — | — | — | 603 | ||||||||||||||||||||||||||||||||
Conversion of convertible preferred stock to common stock | — | — | — | 68 |
Year Ended September 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2012 | December 3, 2003 (Inception) to September 30, 2012 | |||||||||||||||
Non-cash financing and investing activities: | ||||||||||||||||||
Warrants issued in connection with registered direct offering | $ | 2,915 | $ | 9,438 | $ | — | $ | 12,353 | ||||||||||
Warrants issued in connection with unregistered common stock — private placement | — | — | 4,832 | 4,832 | ||||||||||||||
Settlement of debt with Series B preferred stock | — | — | — | 3,202 | ||||||||||||||
Accrued expenses settled with Series B preferred stock | — | — | — | 150 | ||||||||||||||
Deemed dividend — warrants | — | — | — | 4,457 | ||||||||||||||
Accretion of fair value of beneficial charge on preferred stock | — | — | — | 603 | ||||||||||||||
Conversion of convertible preferred stock to common stock | — | — | — | 68 | ||||||||||||||
Issuance of restricted stock units to settle accrued bonus | — | — | 584 | 584 |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | 2010 | 2011 | 2012 | |||||||||||||||||||||||||
Expected life (in years) | 5.25 | 2.72 – 5.25 | 3.77 – 5.25 | 2.72 – 5.25 | 3.77 – 5.25 | 3.0 – 4.75 | ||||||||||||||||||||||||
Expected volatility | 59 – 68 | % | 64 – 77 | % | 65 – 72 | % | 64 – 77 | % | 65 – 72 | % | 58 – 76 | % | ||||||||||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||||||||
Risk-free interest rate | 1.00% – 3.19 | % | 0.77 – 2.69 | % | 0.75 – 1.97 | % | 0.77 – 2.69 | % | 0.75 – 1.97 | % | 0.39 – 0.91 | % | ||||||||||||||||||
Weighted-average grant date fair value | $ | 2.69 | $ | 4.09 | $ | 1.59 | $ | 16.37 | $ | 6.36 | $ | 2.54 |
Description | Fair Value at September 30, 2012 | 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 | $ | 39,050 | $ | 39,050 | $ | — | $ | — | ||||||||||
Restricted cash | 60 | 60 | — | — | ||||||||||||||
Subtotal | 39,110 | 39,110 | — | — | ||||||||||||||
Liabilities: | ||||||||||||||||||
Common stock warrant liability | (7,338 | ) | — | — | (7,338 | ) | ||||||||||||
Subtotal | (7,338 | ) | — | — | (7,338 | ) | ||||||||||||
Total | $ | 31,772 | $ | 39,110 | $ | — | $ | (7,338 | ) |
Description | Fair Value at September 30, 2011 | 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 | $ | 38,701 | $ | 38,701 | $ | — | $ | — | ||||||||||
Restricted cash | 60 | 60 | — | — | ||||||||||||||
Subtotal | 38,761 | 38,761 | — | — | ||||||||||||||
Liabilities: | ||||||||||||||||||
Common stock warrant liability | (996 | ) | — | — | (996 | ) | ||||||||||||
Subtotal | (996 | ) | — | — | (996 | ) | ||||||||||||
Total | $ | 37,765 | $ | 38,761 | $ | — | $ | (996 | ) |
Description | Fair Value at September 30, 2010 | 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 | $ | 22,922 | $ | 22,922 | $ | — | $ | — | ||||||||||
Restricted cash | 150 | 150 | — | — | ||||||||||||||
Marketable securities: | ||||||||||||||||||
US government agency securities (short-term securities) | 6,001 | 6,001 | — | — | ||||||||||||||
Subtotal | 29,073 | 29,073 | — | — | ||||||||||||||
Liabilities: | ||||||||||||||||||
Common stock warrant liability | (4,169 | ) | — | — | (4,169 | ) | ||||||||||||
Subtotal | (4,169 | ) | — | — | (4,169 | ) | ||||||||||||
Total | $ | 24,904 | $ | 29,073 | $ | — | $ | (4,169 | ) |
Balance at September 30, 2009 | $ | — | ||||
August 2010 warrant — initial fair value at the date of issuance | (2,915 | ) | ||||
Increase in fair value | (1,254 | ) | ||||
Balance at September 30, 2010 | (4,169 | ) | ||||
May 2011 warrant — initial fair value at the date of issuance | (9,438 | ) | ||||
Exercise of warrants | 29 | |||||
Decrease in fair value | 12,582 | |||||
Balance at September 30, 2011 | (996 | ) |
June 2012 warrant — initial fair value at the date of issuance | (4,832 | ) | ||||
Increase in fair value | (1,510 | ) | ||||
Balance at September 30, 2012 | $ | ( | ) |
Description | Quoted Prices in Active Markets for identical Assets and Liabilities (Level 1) | Significant other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Balance as of September 30, 2011 | Quoted Prices in Active Markets for identical Assets and Liabilities (Level 1) | Significant other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Balance as of September 30, 2012 | ||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Derivative liabilities related to Warrants | $ | — | $ | — | $ | 996 | $ | 996 | $ | — | $ | — | $ | 7,338 | $ | 7,338 |
Description | Balance at September 30, 2010 | Fair Value of warrants upon issuance | Unrealized (gains) or losses | Balance as of September 30, 2011 | Fair Value of warrants upon issuance | Unrealized (gains) or losses | Balance as of September 30, 2012 | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Derivative liabilities related to Warrants | $ | 4,169 | $ | 9,438 | $ | (12,611 | ) | $ | 996 | $ | 4,832 | �� | $ | 1,510 | $ | 7,338 |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | 2010 | 2011 | 2012 | |||||||||||||||||||||||||
Common shared issuable upon conversion of Series A Preferred Stock | — | — | 1,813,944 | |||||||||||||||||||||||||||
Common shares underlying warrants for Series A Preferred Stock | 118,815 | 118,815 | 1,297,878 | |||||||||||||||||||||||||||
Common shares issuable upon conversion of Series A Preferred Stock | — | 453,486 | 453,486 | |||||||||||||||||||||||||||
Common shares issuable upon conversion of Series B Preferred Stock | — | — | 3,605,607 | |||||||||||||||||||||||||||
Common shares underlying warrants issued for common stock | — | 2,398,200 | 10,204,709 | 629,254 | 2,875,647 | 5,006,398 | ||||||||||||||||||||||||
Stock options | 3,407,633 | 4,635,532 | 5,461,295 | 1,158,891 | 1,365,350 | 1,546,454 | ||||||||||||||||||||||||
Restricted stock units | — | 249,020 | 486,723 | 62,264 | 121,677 | 68,153 |
September 30, | September 30, | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2011 | 2012 | |||||||||||||||||||
Furniture and fixtures | $ | 324 | $ | 324 | $ | 324 | $ | 324 | ||||||||||||||
Leasehold improvements | 1,549 | 1,548 | 1,548 | 1,548 | ||||||||||||||||||
Construction-in-progress | 63 | 38 | 38 | 0 | ||||||||||||||||||
Laboratory equipment | 1,756 | 1,886 | 1,886 | 1,945 | ||||||||||||||||||
Manufacturing equipment | 587 | 655 | 655 | 655 | ||||||||||||||||||
Facility equipment | 65 | 65 | 65 | 65 | ||||||||||||||||||
Computer equipment and other | 1,291 | 1,308 | 1,308 | 1,308 | ||||||||||||||||||
Sub-Total | 5,635 | 5,824 | 5,824 | 5,845 | ||||||||||||||||||
Less: Accumulated depreciation and amortization | 2,637 | 3,571 | 3,571 | 4,293 | ||||||||||||||||||
Total | $ | 2,998 | $ | 2,253 | $ | 2,253 | $ | 1,552 |
• | two times his then current salary, plus two times his target annual bonus for the fiscal year in which he is terminated, plus the pro rata amount of his target annual bonus for the fiscal year in which he is terminated; |
• | COBRA benefits until the earlier of the end of the 24th month after the date his employment with the Company ends or the date his COBRA coverage expires; |
• | 24 months of acceleration of his outstanding equity compensation awards; and |
• | full vesting of his outstanding equity compensation awards, if the Company terminates his employment without cause, or he resigns within 12 months following a change in control, as defined in the agreement. |
Years Ending September 30, | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
2012 | $ | 689 | ||||||||||
2013 | 613 | $ | 594 | |||||||||
2014 | 478 | 463 | ||||||||||
2015 | — | |||||||||||
Total | $ | 1,780 | $ | 1,057 |
Years Ending September 30, | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
2013 | $ | — | ||||||||||
2014 | $ | 1,119 | 1,078 | |||||||||
2015 | 4,702 | �� | 4,367 | |||||||||
2016 | 5,090 | 4,488 | ||||||||||
2017 | 5,551 | 4,577 | ||||||||||
2018 | 4,461 | 3,510 | ||||||||||
Total | $ | 20,923 | $ | 18,020 |
Year Ended September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | |||||||||||||
Balance, beginning of year | $ | 988 | $ | 188 | $ | 86 | |||||||||
Increase related to current year tax position | 6 | 5 | — | ||||||||||||
Increase related to prior year’s tax position | 107 | — | — | ||||||||||||
Decrease related to prior year’s tax position | (913 | ) | (107 | ) | (11 | ) | |||||||||
Balance, at end of year | $ | 188 | $ | 86 | $ | 75 |
Year Ended September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | |||||||||||||
Current expense | |||||||||||||||
Federal | $ | — | $ | — | $ | — | |||||||||
State | 337 | (104 | ) | 41 | |||||||||||
Actual tax provision (benefit) | $ | 337 | $ | (104 | ) | $ | 41 |
September 30, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | ||||||||||
Deferred Tax Assets | |||||||||||
Net operating losses | $ | 46,917 | $ | 23,699 | |||||||
Capitalized expense | — | 16,936 | |||||||||
Research and development credits | 2,800 | 477 | |||||||||
Depreciation of fixed assets | 166 | 303 | |||||||||
Other | 176 | 765 | |||||||||
Total deferred tax asset | 50,059 | 42,180 | |||||||||
Valuation Allowance | (50,059 | ) | (42,180 | ) | |||||||
Net Deferred Tax Assets | $ | — | $ | — |
Year Ended September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2012 | |||||||||||||
Current expense | |||||||||||||||
Federal | $ | — | $ | — | $ | — | |||||||||
State | (104 | ) | 41 | 18 | |||||||||||
Actual tax provision (benefit) | $ | (104 | ) | $ | 41 | $ | 18 |
Year Ended September 30, | Year Ended September 30, | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | 2010 | 2011 | 2012 | |||||||||||||||||||||||||
Federal statutory rate | 34.00 | % | 34.00 | % | 34.00 | % | 34.00 | % | 34.00 | % | 34.00 | % | ||||||||||||||||||
Federal taxes at statutory rate | $ | (14,597 | ) | $ | (13,054 | ) | $ | (3,587 | ) | $ | (13,054 | ) | $ | (3,587 | ) | $ | (7,028 | ) | ||||||||||||
Tax expense on permanent differences(a) | 1,741 | 2,296 | (2,631 | ) | 2,296 | (2,631 | ) | 1,137 | ||||||||||||||||||||||
Tax benefit on research and business credits | (325 | ) | (425 | ) | — | (425 | ) | — | — | |||||||||||||||||||||
State taxes, net of federal tax effect | 43 | 23 | 19 | 23 | 19 | 12 | ||||||||||||||||||||||||
State benefit, net operating loss | (1,249 | ) | (2,990 | ) | (163 | ) | (2,990 | ) | (163 | ) | (312 | ) | ||||||||||||||||||
Valuation allowance increase(b) | 14,432 | 14,156 | 6,382 | 14,156 | 6,382 | 6,164 | ||||||||||||||||||||||||
Connecticut research and development refund | (40 | ) | (30 | ) | — | (30 | ) | — | — | |||||||||||||||||||||
Reserve for uncertain tax positions | 6 | 4 | — | 4 | — | — | ||||||||||||||||||||||||
Other | 326 | (84 | ) | 21 | (84 | ) | 21 | 45 | ||||||||||||||||||||||
Actual tax provision (benefits) | $ | 337 | $ | (104 | ) | $ | 41 | |||||||||||||||||||||||
Actual tax provision (benefit) | $ | (104 | ) | $ | 41 | $ | 18 |
(a) | Permanent differences were derived from share based compensation and adjustments to common stock warrant liability. |
(b) | Net of the Section 382 Adjustment. |
Year Ended September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2012 | |||||||||||||
Balance, beginning of year | $ | 188 | $ | 86 | $ | 75 | |||||||||
Increase related to current year tax position | 5 | — | — | ||||||||||||
Increase related to prior year’s tax position | — | — | — | ||||||||||||
Decrease related to prior year’s tax position | (107 | ) | (11 | ) | — | ||||||||||
Balance, at end of year | $ | 86 | $ | 75 | $ | 75 |
September 30, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
2011 | 2012 | ||||||||||
Deferred Tax Assets | |||||||||||
Net operating losses | $ | 23,699 | $ | 24,969 | |||||||
Capitalized expense | 16,936 | 21,907 | |||||||||
Research and development credits | 477 | 477 | |||||||||
Depreciation of fixed assets | 303 | 51 | |||||||||
Other | 765 | 453 | |||||||||
Total deferred tax asset | 42,180 | 47,857 | |||||||||
Valuation Allowance | (42,180 | ) | (47,857 | ) | |||||||
Net Deferred Tax Assets | $ | — | $ | — |
Balance at September 30, 2011 | $ | — | ||||
Initial fair value, at the date of issuance | 4,832 | |||||
Increase in fair value | 801 | |||||
Balance at September 30, 2012 | $ | 5,633 |
Balance at September 30, 2010 | $ | — | ||||
Initial fair value, at the date of issuance | 9,438 | |||||
Decrease in fair value | (8,442 | ) | ||||
Balance at September 30, 2011 | 996 | |||||
Increase in fair value | 709 | |||||
Balance at September 30, 2012 | $ |
September 30, 2012 | ||||||
---|---|---|---|---|---|---|
June 2012 Financing | ||||||
Stock price | $ | 2.97 | ||||
Exercise price | $ | 2.66 | ||||
Risk-free interest rate | 0.62 | % | ||||
Expected remaining term | 4.74 | years | ||||
Expected volatility | 98 | % | ||||
Dividend yield | 0 | % | ||||
Warrants outstanding June 2012 registered direct | 2,749,469 |
September 30, 2010 | September 30, 2011 | September 30, 2011 | September 30, 2012 | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
August 2010 Financing | ||||||||||||||||||||
May 2011 Financing | ||||||||||||||||||||
Stock price | $ | 2.16 | $ | 2.97 | ||||||||||||||||
Exercise price | $ | 9.92 | $ | 9.92 | ||||||||||||||||
Risk-free interest rate | .25 | % | .02 | % | 0.96 | % | 0.31 | % | ||||||||||||
Expected remaining term | 1.17 | years | .2 | years | 4.63 | years | 3.63 | years | ||||||||||||
Expected volatility | 100 | % | 60 | % | 75 | % | 82 | % | ||||||||||||
Dividend yield | 0 | % | 0 | % | 0 | % | 0 | % | ||||||||||||
Warrants outstanding August 2010 registered direct | 2,398,200 | 2,356,000 | ||||||||||||||||||
Warrants outstanding May 2011 registered direct | 2,256,929 | 2,256,929 |
May 2011 financing — |
(a) | warrants to purchase |
(b) | Series A |
(ii) | June 2012 financing — |
(a) | warrants to purchase 1,487,507 shares of the Company’s common stock with an exercise price of $2.66 per share and |
(b) | Series B convertible preferred stock — warrants to purchase 1,261,922 shares of the Company’s common stock with an exercise price of $2.66 per share. |
2010 stock incentive plan | ||||||
2005 employee stock purchase plan | ||||||
Common shares issuable upon conversion of Series A Preferred Stock | ||||||
Common shares issuable upon conversion of Series B Preferred Stock | ||||||
Warrants issued in connection with May 2011 registered direct offering | ||||||
Warrants issued in connection with June 2012 private placement | ||||||
Total | 11,717,399 |
Options | Number | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Balance, September 30, 2004 | — | $ | — | $ | — | |||||||||||||
Granted | 96,358 | 5.64 | — | |||||||||||||||
Outstanding balance, September 30, 2005 | 96,358 | 5.64 | — | |||||||||||||||
Granted | 115,401 | 22.60 | — | |||||||||||||||
Forfeited, expired | 15,054 | 13.60 | — | |||||||||||||||
Outstanding balance, September 30, 2006 | 196,705 | 12.92 | — | |||||||||||||||
Granted | 238,961 | 55.84 | — | |||||||||||||||
Exercised | 886 | 5.64 | — | |||||||||||||||
Forfeited, expired | 13,283 | 22.60 | — | |||||||||||||||
Outstanding balance, September 30, 2007 | 421,497 | 27.20 | — | |||||||||||||||
Granted | 431,849 | 67.52 | — | |||||||||||||||
Exercised | 43,604 | 20.72 | — | |||||||||||||||
Forfeited, expired | 25,892 | 44.16 | — | |||||||||||||||
Outstanding balance, September 30, 2008 | 783,850 | 55.68 | — | |||||||||||||||
Granted | 152,875 | 10.76 | — | |||||||||||||||
Exercised | 4,416 | 5.64 | — | |||||||||||||||
Forfeited, expired | 80,398 | 55.52 | — |
Options | Number | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | Number | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | ||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Balance, September 30, 2004 | — | $ | — | $ | — | |||||||||||||||||||||||||||||||
Granted | 385,432 | 1.41 | — | |||||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2005 | 385,432 | 1.41 | — | |||||||||||||||||||||||||||||||||
Granted | 461,602 | 5.65 | — | |||||||||||||||||||||||||||||||||
Forfeited, expired | 60,222 | 3.40 | — | |||||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2006 | 786,812 | 3.23 | — | |||||||||||||||||||||||||||||||||
Granted | 955,842 | 13.96 | — | |||||||||||||||||||||||||||||||||
Exercised | 3,542 | 1.41 | — | |||||||||||||||||||||||||||||||||
Forfeited, expired | 53,138 | 5.65 | — | |||||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2007 | 1,685,974 | 6.80 | — | |||||||||||||||||||||||||||||||||
Granted | 1,727,397 | 16.88 | — | |||||||||||||||||||||||||||||||||
Exercised | 174,410 | 5.18 | — | |||||||||||||||||||||||||||||||||
Forfeited, expired | 103,571 | 11.04 | — | |||||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2008 | 3,135,390 | $ | 13.92 | — | ||||||||||||||||||||||||||||||||
Granted | 611,500 | 2.69 | — | |||||||||||||||||||||||||||||||||
Exercised | 17,661 | 1.41 | — | |||||||||||||||||||||||||||||||||
Forfeited, expired | 321,596 | 13.88 | — | |||||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2009 | 3,407,633 | $ | 11.81 | — | 851,911 | 47.24 | — | |||||||||||||||||||||||||||||
Granted | 1,314,100 | 4.09 | — | 328,530 | 16.37 | — | ||||||||||||||||||||||||||||||
Exercised | 32,320 | 2.11 | — | 8,081 | 8.43 | — | ||||||||||||||||||||||||||||||
Forfeited, expired | 53,880 | 13.04 | — | 13,469 | 52.16 | — | ||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2010 | 4,635,533 | $ | 9.68 | — | 1,158,891 | 38.72 | — | |||||||||||||||||||||||||||||
Granted | 1,163,273 | 1.59 | — | 290,834 | 6.36 | — | ||||||||||||||||||||||||||||||
Exercised | 417 | 1.41 | — | 104 | 5.64 | — | ||||||||||||||||||||||||||||||
Forfeited, expired | 337,094 | 9.62 | — | 84,271 | 38.48 | — | ||||||||||||||||||||||||||||||
Outstanding balance, September 30, 2011 | 5,461,295 | $ | 8.17 | 5 | $ | — | 1,365,350 | 32.68 | — | |||||||||||||||||||||||||||
Exercisable shares, September 30, 2011 | 3,217,200 | $ | 10.45 | 4 | $ | — | ||||||||||||||||||||||||||||||
Granted | 215,877 | 2.54 | — | |||||||||||||||||||||||||||||||||
Forfeited, expired | 34,773 | 32.09 | — | |||||||||||||||||||||||||||||||||
Outstanding balance September 30, 2012 | 1,546,454 | $ | 27.80 | 4 | $ | — | ||||||||||||||||||||||||||||||
Exercisable shares, September 30, 2012 | 1,197,230 | $ | 33.39 | 3 | $ | — |
September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2009 | 2010 | 2011 | |||||||||||||
Stock compensation expense — RSUs | $ | — | $ | 205 | $ | 585 |
September 30, | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2010 | 2011 | 2012 | |||||||||||||
Stock compensation expense — RSUs | $ | 205 | $ | 585 | $ | 1,202 |
Shares | Weighted Average Grant-Date Fair Value | Shares | Weighted Average Grant-Date Fair Value | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Non-vested and outstanding balance at September 30, 2009 | — | $ | — | — | $ | — | ||||||||||||||
Shares granted | 250,000 | 3.95 | 62,510 | 15.80 | ||||||||||||||||
Shares forfeited or expired | 980 | 3.95 | 246 | 15.80 | ||||||||||||||||
Non-vested and outstanding balance at September 30, 2010 | 249,020 | 3.95 | 62,264 | 15.80 | ||||||||||||||||
Changes during the period: | ||||||||||||||||||||
Shares granted | 362,562 | 1.89 | 90,639 | 7.56 | ||||||||||||||||
Shares vested and issued | (89,711 | ) | 4.30 | 22,435 | 17.20 | |||||||||||||||
Shares forfeited or expired | (35,148 | ) | 2.37 | 8,791 | 9.40 | |||||||||||||||
Non-vested and outstanding balance at September 30, 2011 | 486,723 | 2.35 | 121,677 | 9.40 | ||||||||||||||||
Changes during the period: | ||||||||||||||||||||
Shares granted | 274,189 | 2.36 | ||||||||||||||||||
Shares vested and issued | 327,713 | 3.45 | ||||||||||||||||||
Non-vested and outstanding balance at September 30, 2012 | 68,153 | $ | 10.51 |
December 31, 2010 | March 31, 2011 | June 30, 2011 | September 30, 2011 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net Profit (loss) | $ | (5,309 | ) | $ | (5,442 | ) | $ | (3,974 | ) | $ | 4,133 | |||||||
Basic net loss per common share(1) | $ | (0.20 | ) | $ | (0.21 | ) | $ | (0.12 | ) | $ | 0.11 | |||||||
Diluted net loss per common share | $ | (0.20 | ) | $ | (0.21 | ) | $ | (0.12 | ) | $ | 0.10 | |||||||
Weighted average common shares basic | 26,419,105 | 26,469,890 | 33,017,859 | 38,631,390 | ||||||||||||||
Weighted average common shares diluted | 26,419,105 | 26,469,890 | 33,017,859 | 40,445,334 |
December 31, 2011 | March 31, 2012 | June 30, 2012 | September 30, 2012 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net loss | $ | (4,501 | ) | $ | (4,316 | ) | $ | (6,051 | ) | $ | (5,879 | ) | ||||||
Basic and diluted net loss per common share(1) | $ | (0.47 | ) | $ | (0.45 | ) | $ | (0.60 | ) | $ | (0.42 | ) | ||||||
Weighted average common shares basic and diluted | 9,673,529 | 9,688,384 | 10,152,194 | 13,982,826 |
December 31, 2009 | March 31, 2010 | June 30, 2010 | September 30, 2010 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net loss | $ | (11,148 | ) | $ | (10,409 | ) | $ | (8,629 | ) | $ | (8,104 | ) | ||||||
Basic and diluted net loss per common share | $ | (0.47 | ) | $ | (0.44 | ) | $ | (0.36 | ) | $ | (0.31 | ) | ||||||
Weighted average common shares basic and diluted | 23,848,855 | 23,885,856 | 23,944,386 | 24,961,083 |
December 31, 2010 | March 31, 2011 | June 30, 2011 | September 30, 2011 | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net (loss) income | $ | (5,309 | ) | $ | (5,442 | ) | $ | (3,974 | ) | $ | 4,133 | |||||||
Basic net (loss) income per common share | $ | (0.80 | ) | $ | (0.82 | ) | $ | (0.48 | ) | $ | 0.43 | |||||||
Diluted net (loss) income per common share(1) | $ | (0.80 | ) | $ | (0.82 | ) | $ | (0.48 | ) | $ | 0.41 | |||||||
Weighted average common shares basic | 6,604,726 | 6,617,422 | 8,254,413 | 9,657,795 | ||||||||||||||
Weighted average common shares diluted | 6,604,726 | 6,617,422 | 8,254,413 | 10,111,336 |
(1) | Basic earnings (loss) per share calculation for the third and fourth quarter include the weighted average effect of stock issuances; therefore, the sum of the quarterly earnings per share will not equal full-year earnings per share amounts which reflect the weighted average effect on an annual basis. |