x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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94-3171943
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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Large accelerated filer
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Accelerated filer
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x |
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Non-accelerated filer
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o (Do not check if a smaller reporting company) |
Smaller reporting company
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Page
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Item 1.
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1
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1
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2
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3
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4
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Item 2.
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14
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Item 3.
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24
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Item 4.
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24
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PART II - OTHER INFORMATION
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Item 1.
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25
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Item 1A.
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25
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Item 2.
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25
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Item 6.
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25
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26
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• | the risk that we will require in the near term, but may be unable to secure, significant additional capital to continue our operations, fund our debt service and support our research and development activities, including expensive and time-consuming clinical trials, until such time, if ever, that our revenues from all sources are sufficient to offset our cash outflows. To the extent that we raise such capital through additional financings, such additional financings could result in equity dilution; |
• | the risk that, if we fail to successfully commercialize SURFAXIN and if we are unable to achieve revenues over the next several years that are consistent with our expectations, it may be more difficult to secure the additional capital we will require when needed, if at all, whether from strategic alliances or other sources, to continue our commercial and medical affairs activities, as well as our research and development programs and our operations would be impaired, which ultimately could have a material adverse effect on our business, financial condition and results of operations; |
• | risks relating to the ability of our sales and marketing organization to effectively introduce SURFAXIN in the United States (U.S.) and, if approved, our other product candidates, in a timely manner, if at all; and that we may not succeed in developing sufficient market awareness of our products or that our product candidates may not gain market acceptance by physicians, patients, healthcare payers and others in the medical community; |
• | risks relating to our ability to timely modify our business strategy to respond to changing circumstances, assumptions and forecasts, and otherwise as needed to manage growth effectively and respond to developments in our commercial operations and research and development activities, as well as our business, our industry and other factors; |
• | the risk that the initial and later phases of our AEROSURF phase 2 clinical program may be interrupted, delayed, or fail, which will harm our business; |
• | the risk that we and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on matters raised during the regulatory review process, or that we may be required to conduct significant additional activities to potentially gain approval of our product candidates, if ever; |
• | risks relating to the transfer of our manufacturing technology to contract manufacturing organizations (CMOs) and assemblers; |
• | risks relating to our and our CMOs' ability to manufacture our KL 4 surfactant, in liquid and lyophilized dosage forms, which must be processed in an aseptic environment and tested using sophisticated and extensive analytical methodologies and quality control release and stability tests, for both commercial and research and development activities; |
• | risks relating to our and our CMOs’ ability to develop and manufacture combination drug/device products based on our CAG technology, for preclinical and clinical studies of our product candidates and, if approved, for commercialization; |
• | the risk that we, our CMOs or any of our third-party suppliers, many of which are single-source providers, may encounter problems in manufacturing our KL 4 surfactant drug products and the APIs used in the manufacture of our drug products, CAG devices and other materials on a timely basis or in an amount sufficient to support our needs; |
• | the risk that we may not succeed in implementing our long-term manufacturing strategy to assure continuity of SURFAXIN commercial drug product supply, which could expose us to risks that may affect our ability to maintain sufficient supplies of SURFAXIN commercial drug product; |
• | the risk that we may be unable to enter into strategic alliances and/or collaboration agreements that would assist and support us in markets outside the U.S. with the development of our KL 4 surfactant pipeline products, beginning with AEROSURF, including development of our lyophilized KL 4 surfactant, and, if approved, commercialization of AEROSURF in markets outside the U.S.; support the commercialization of SURFAXIN in countries where regulatory approval is facilitated by the information contained in the SURFAXIN new drug application (NDA) approved by the FDA; and potentially support the development and, if approved, commercialization, of our other pipeline products; |
• | risks relating to our plans potentially to secure marketing and distribution capabilities in certain markets through third-party strategic alliances and/or marketing alliances and/or distribution arrangements, that could require us to give up rights to our drug products, drug product candidates and drug delivery technologies; |
• | risks relating to our pledge of substantially all of our assets to secure our obligations under our loan facility (Deerfield Loan) with affiliates of Deerfield Management Company, L.P., which could make it more difficult for us to secure additional capital to satisfy our obligations and require us to dedicate cash flow to payments for debt service, which would reduce the availability of our cash flow to fund working capital, capital expenditures and other investment; and |
• | other risks and uncertainties as detailed in “Risk Factors” in our most recent Annual Report on Form 10‑K filed with the Securities and Exchange Commission (SEC) on March 17, 2014, and our other filings with the SEC and any amendments thereto, and in the documents incorporated by reference in this report. |
(in thousands, except per share data)
|
||||||||
|
March 31,
|
December 31,
|
||||||
|
2014
|
2013
|
||||||
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(Unaudited)
|
|
||||||
ASSETS
|
|
|
||||||
Current Assets:
|
|
|
||||||
Cash and cash equivalents
|
$
|
75,942
|
$
|
86,283
|
||||
Accounts receivable
|
–
|
67
|
||||||
Inventory, net
|
173
|
112
|
||||||
Prepaid expenses and other current assets
|
702
|
777
|
||||||
Total current assets
|
76,817
|
87,239
|
||||||
Property and equipment, net
|
2,007
|
1,656
|
||||||
Restricted cash
|
325
|
325
|
||||||
Other assets
|
349
|
97
|
||||||
Total assets
|
$
|
79,498
|
$
|
89,317
|
||||
LIABILITIES & STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable
|
$
|
2,578
|
$
|
1,433
|
||||
Accrued expenses
|
3,726
|
4,785
|
||||||
Deferred revenue
|
85
|
139
|
||||||
Common stock warrant liability
|
4,672
|
5,425
|
||||||
Equipment loans, current portion
|
74
|
73
|
||||||
Total current liabilities
|
11,135
|
11,855
|
||||||
|
||||||||
Long-term debt, $30,000 net of discount of $11,207 at March 31, 2014 and $11,646 at December 31, 2013
|
18,793
|
18,354
|
||||||
Equipment loans, non-current portion
|
49
|
69
|
||||||
Other liabilities
|
714
|
538
|
||||||
Total liabilities
|
30,691
|
30,816
|
||||||
Stockholders’ Equity:
|
||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding
|
–
|
–
|
||||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 85,073,173 and 84,659,111 shares issued at March 31, 2014 and December 31, 2013, respectively; 85,052,281 and 84,638,219 shares outstanding at March 31, 2014 and December 31, 2013, respectively
|
85
|
85
|
||||||
Additional paid-in capital
|
543,202
|
541,420
|
||||||
Accumulated deficit
|
(491,426
|
)
|
(479,950
|
)
|
||||
Treasury stock (at cost); 20,892 shares
|
(3,054
|
)
|
(3,054
|
)
|
||||
Total stockholders’ equity
|
48,807
|
58,501
|
||||||
Total liabilities & stockholders’ equity
|
$
|
79,498
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$
|
89,317
|
(in thousands, except per share data)
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|
|||||||
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Three Months Ended
|
|||||||
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
|
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|
||||||
|
|
|
||||||
Revenues:
|
|
|
||||||
Product sales
|
$
|
28
|
$
|
–
|
||||
Grant revenue
|
3
|
72
|
||||||
|
31
|
72
|
||||||
Expenses:
|
||||||||
Cost of product sales
|
781
|
–
|
||||||
Research and development
|
5,590
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8,472
|
||||||
Selling, general and administrative
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4,423
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4,220
|
||||||
|
10,794
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12,692
|
||||||
Operating loss
|
(10,763
|
)
|
(12,620
|
)
|
||||
|
||||||||
Change in fair value of common stock warrant liability
|
378
|
162
|
||||||
|
||||||||
Other income / (expense):
|
||||||||
Interest and other income
|
2
|
1
|
||||||
Interest and other expense
|
(1,093
|
)
|
(178
|
)
|
||||
Other income / (expense), net
|
(1,091
|
)
|
(177
|
)
|
||||
Net loss
|
$
|
(11,476
|
)
|
$
|
(12,635
|
)
|
||
Net loss per common share – Basic and diluted
|
$
|
(0.14
|
)
|
$
|
(0.29
|
)
|
||
Weighted-average number of common shares outstanding – basic and diluted
|
84,728
|
43,657
|
|
Three Months Ended
|
|||||||
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
|
|
|
||||||
Cash flows from operating activities:
|
|
|
||||||
Net loss
|
$
|
(11,476
|
)
|
$
|
(12,635
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
149
|
197
|
||||||
Provision for excess inventory
|
766
|
–
|
||||||
Stock-based compensation and 401(k) Plan employer match
|
954
|
612
|
||||||
Fair value adjustment of common stock warrants
|
(378
|
)
|
(162
|
)
|
||||
Amortization of discount on long-term debt
|
439
|
59
|
||||||
Changes in:
|
||||||||
Inventory
|
(1,083
|
)
|
195
|
|||||
Accounts receivable
|
67
|
–
|
||||||
Prepaid expenses and other current assets
|
75
|
98
|
||||||
Accounts payable
|
1,145
|
659
|
||||||
Accrued expenses
|
(1,059
|
)
|
814
|
|||||
Deferred revenue
|
(54
|
)
|
–
|
|||||
Other assets
|
–
|
(111
|
)
|
|||||
Other liabilities
|
176
|
39
|
||||||
Net cash used in operating activities
|
(10,279
|
)
|
(10,235
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchase of property and equipment
|
(497
|
)
|
(120
|
)
|
||||
Net cash used in investing activities
|
(497
|
)
|
(120
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of long-term debt, net of expenses
|
–
|
9,850
|
||||||
Proceeds from exercise of common stock options
|
31
|
1
|
||||||
Proceeds from exercise of common stock warrants
|
423
|
–
|
||||||
Repayment of equipment loans
|
(19
|
)
|
(18
|
)
|
||||
Net cash provided by financing activities
|
435
|
9,833
|
||||||
Net decrease in cash and cash equivalents
|
(10,341
|
)
|
(522
|
)
|
||||
Cash and cash equivalents – beginning of period
|
86,283
|
26,892
|
||||||
Cash and cash equivalents – end of period
|
$
|
75,942
|
$
|
26,370
|
||||
Supplementary disclosure of cash flows information:
|
||||||||
Interest paid
|
$
|
649
|
$
|
116
|
· | Chargebacks . Chargebacks are discounts that occur when contracted customers purchase directly from our specialty distributor. Contracted customers, which currently consist primarily of member hospitals of Group Purchasing Organizations, generally purchase the product at a discounted price. Our specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the customer. The allowance for specialty distributor chargebacks is based on known sales to contracted customers. |
· | Sales discounts : Sales discounts are offered to certain contracted customers based upon a customer’s historical volume of surfactant product purchases. Customers must enter into a Letter of Participation (LOP) with us to receive sales discounts. Sales discounts are periodically adjusted on a prospective basis based upon the customer’s purchases of SURFAXIN, as provided in the LOP. The allowance for sales discounts is based on known sales to contracted customers. |
· | Specialty distributor deductions . Our specialty distributor is offered various forms of consideration including allowances, service fees and prompt payment discounts. Specialty distributor allowances and service fees are provided in our contractual agreement and are generally a percentage of the purchase price paid by the specialty distributor. The specialty distributor is offered a prompt pay discount for payment within a specified period. |
· | Returns . Sales of our products are not subject to a general right of return; however, we will accept product that is damaged or defective when shipped or for expired product up to six months subsequent to its expiry date. Product that has been administered to patients is no longer subject to any right of return. |
· | Level 1 – Quoted prices in active markets for identical assets and liabilities. |
· | Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
· | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
|
Fair Value
|
Fair value measurement using
|
||||||||||||||
|
March 31, 2014
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
|
|
|
|
|||||||||||||
Assets:
|
|
|
|
|
||||||||||||
Cash and cash equivalents
|
$
|
75,942
|
$
|
75,942
|
$
|
–
|
$
|
–
|
||||||||
Certificate of Deposit
|
325
|
325
|
–
|
–
|
||||||||||||
Total Assets
|
$
|
76,267
|
$
|
76,267
|
$
|
–
|
$
|
–
|
||||||||
|
||||||||||||||||
Liabilities:
|
||||||||||||||||
Common stock warrant liability
|
$
|
4,672
|
$
|
–
|
$
|
–
|
$
|
4,672
|
|
Fair Value
|
Fair value measurement using
|
||||||||||||||
|
December 31,
2013
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
|
|
|
|
|||||||||||||
Assets:
|
|
|
|
|
||||||||||||
Cash and cash equivalents
|
$
|
86,283
|
$
|
86,283
|
$
|
–
|
$
|
–
|
||||||||
Certificate of Deposit
|
325
|
325
|
–
|
–
|
||||||||||||
Total Assets
|
$
|
86,608
|
$
|
86,608
|
$
|
–
|
$
|
–
|
||||||||
|
||||||||||||||||
Liabilities:
|
||||||||||||||||
Common stock warrant liability
|
$
|
5,425
|
$
|
–
|
$
|
–
|
$
|
5,425
|
(in thousands)
|
Fair Value Measurements of
Common Stock Warrants Using
Significant Unobservable Inputs
(Level 3)
|
|||
|
||||
Balance at December 31, 2013
|
$
|
5,425
|
||
Exercise of warrants
|
(375
|
)
|
||
Change in fair value of common stock warrant liability
|
(378
|
)
|
||
Balance at March 31, 2014
|
$
|
4,672
|
(in thousands)
|
Fair Value Measurements of
Common Stock Warrants Using
Significant Unobservable Inputs
(Level 3)
|
|||
|
||||
Balance at December 31, 2012
|
$
|
6,305
|
||
Change in fair value of common stock warrant liability
|
(162
|
)
|
||
Balance at March 31, 2013
|
$
|
6,143
|
Significant Unobservable Input
Assumptions of Level 3 Valuations
|
March 31, 2014
|
December 31, 2013
|
||||||
|
|
|
||||||
Historical Volatility
|
60%-62
|
%
|
62% -76
|
%
|
||||
Expected Term (in years)
|
0.1 – 1.9
|
0.4 – 2.1
|
||||||
Risk-free interest rate
|
0.03% - 0.41
|
%
|
0.08% - 0.44
|
%
|
March 31,
|
December 31,
|
|||||||
(in thousands)
|
2014
|
2013
|
||||||
|
||||||||
Inventories, current:
|
||||||||
Raw materials
|
$
|
52
|
$
|
52
|
||||
Finished goods, net of reserves
|
121
|
60
|
||||||
|
173
|
112
|
||||||
Inventories, non-current:
|
||||||||
Raw materials
|
256
|
–
|
||||||
Total inventories, net
|
$
|
429
|
$
|
112
|
|
|
|
Fair Value of Warrants
(in thousands)
|
||||||||||||||||||
Issuance
Date
|
Number of
Warrant Shares
Issuable
|
Exercise
Price
|
Warrant
Expiration
Date
|
Value at
Issuance
Date
|
|||||||||||||||||
March 31,
2014
|
December 31,
2013
|
||||||||||||||||||||
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
5/13/2009
|
466,667
|
$
|
17.25
|
5/13/2014
|
$
|
3,360
|
$
|
–
|
$
|
–
|
|||||||||||
2/23/2010
|
916,669
|
12.75
|
2/23/2015
|
5,701
|
1
|
6
|
|||||||||||||||
2/22/2011
|
4,552,600
|
1.50
|
2/22/2016
|
8,004
|
4,671
|
5,419
|
|||||||||||||||
|
|
$
|
4,672
|
$
|
5,425
|
March 31,
|
December 31,
|
|||||||
(in thousands)
|
2014
|
2013
|
||||||
|
||||||||
Note Payable
|
$
|
30,000
|
$
|
30,000
|
||||
Unamortized discount
|
(11,207
|
)
|
(11,646
|
)
|
||||
Long-term debt, net of discount
|
$
|
18,793
|
$
|
18,354
|
Three months ended
|
||||||||
(in thousands)
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
|
|
|
||||||
Cash interest expense
|
$
|
647
|
$
|
113
|
||||
Non-cash amortization of debt discount
|
439
|
57
|
||||||
Amortization of debt costs
|
5
|
5
|
||||||
Total interest expense
|
$
|
1,091
|
$
|
175
|
March 31,
|
||||||||
2014
|
2013
|
|||||||
Weighted-average expected volatility
|
100
|
%
|
110
|
%
|
||||
Weighted-average expected term
|
5.4 years
|
4.8 years
|
||||||
Weighted-average risk-free interest rate
|
1.6
|
%
|
0.74
|
%
|
||||
Expected dividends
|
–
|
–
|
Three Months Ended
|
||||||||
(in thousands)
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
Research & Development
|
$
|
248
|
$
|
141
|
||||
Selling, General & Administrative
|
455
|
215
|
||||||
Total
|
$
|
703
|
$
|
356
|
·
|
With the commercial introduction of SURFAXIN underway, our commercial and medical teams are focused on forming relationships with key constituents in our target hospitals, including neonatologists, pharmacists, respiratory therapists, NICU nurses and other staff in the NICU with the goal of obtaining formulary acceptance and, ultimately, product utilization in our target hospitals. We also are focused on conducting in-service training to assure that SURFAXIN is administered in a safe and consistent manner.
|
· | Our AEROSURF phase 2 clinical program is underway. The initial phase 2a clinical trial is designed to assess the safety and tolerability of aerosolized KL 4 surfactant in premature infants 29 to 32 weeks gestational age receiving nCPAP for RDS. Results are expected in the third quarter of 2014. We currently are planning for, and expect to initiate, a phase 2b clinical study in the second half of 2014 and expect to complete it in the second half of 2015. |
· |
We are progressing with our long-term manufacturing strategy. We are continuing to explore possible alternatives that could enable longer-term utilization of our Totowa Facility, the lease for which currently is scheduled to expire on June 30, 2015. We are also pursuing potentially manufacturing KL
4
surfactant using third-party CMOs. Since 2012, we having been working with DSM to complete a technology transfer of our liquid KL
4
surfactant manufacturing process to DSM and we have entered into a supply agreement with DSM that provides for the manufacture of commercial supply of SURFAXIN drug product through December 31, 2015, with such potential extensions as we may agree. We also are working to identify a second CMO to manufacture SURFAXIN drug product. Although we believe that we will successfully execute our plan to provide for the long-term availability of SURFAXIN drug product, there can be no assurance that we will be successful. See our 2013 Form 10-K "Item – 1A – Risk Factors – Our manufacturing strategy includes relying, at least in part in the future, on third parties to manufacture our current approved products as well as certain of our drug product candidates and medical devices, which exposes us to risks that may affect our ability to maintain supplies of our commercial products and/or delay our research and development activities, regulatory approval and commercialization of our drug product candidates."
|
· | We recently announced that we have secured three additional patents in the U.S., including two patents containing composition of matter and method of making claims for our lyophilized KL 4 surfactant, which extend to 2033, and one related to our novel AFECTAIR aerosol-conducting airway connector that extends to April 2029. These patents are indicative of our efforts to protect the long-term commercial potential of our KL 4 surfactant and aerosol delivery technologies. our lyophilized KL 4 surfactant is being developed initially for our AEROSURF development program. Our longer term goal is to develop our technologies to address other potential indications that could benefit from our proprietary KL 4 surfactant. |
(in thousands)
|
Three Months Ended
March 31,
|
|||||||
Research and Development Expenses
|
2014
|
2013
|
||||||
|
||||||||
Product development and manufacturing
|
$
|
3,623
|
$
|
6,824
|
||||
Medical and regulatory operations
|
1,633
|
1,451
|
||||||
Direct preclinical and clinical programs
|
333
|
197
|
||||||
Total Research & Development Expenses
|
$
|
5,590
|
$
|
8,472
|
(in thousands)
|
Three Months Ended
March 31,
|
|||||||
2014
|
2013
|
|||||||
Selling, General and Administrative Expenses
|
$
|
4,423
|
$
|
4,220
|
(in thousands)
|
Three Months Ended
March 31,
|
|||||||
2014
|
2013
|
|||||||
Change in fair value of common stock warrant liability
|
$
|
378
|
$
|
162
|
Three months ended
|
||||||||
(in thousands)
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
|
|
|
||||||
Interest income
|
$
|
2
|
$
|
1
|
||||
Interest expense
|
(1,093
|
)
|
(178
|
)
|
||||
Other income / (expense), net
|
$
|
(1,091
|
)
|
$
|
(177
|
)
|
Three months ended
|
||||||||
(in thousands)
|
March 31,
|
|||||||
|
2014
|
2013
|
||||||
|
|
|
||||||
Cash interest expense
|
$
|
647
|
$
|
113
|
||||
Non-cash amortization of debt discount
|
439
|
57
|
||||||
Amortization of debt costs
|
5
|
5
|
||||||
Total interest expense
|
$
|
1,091
|
$
|
175
|
|
Discovery Laboratories, Inc.
(Registrant)
|
|
|
|
|
Date: May 12, 2014
|
By:
|
/s/ John G. Cooper
|
|
|
John G. Cooper
|
|
|
President and Chief Executive Officer
|
|
|
|
Date: May 12, 2014
|
By:
|
/s/ John Tattory
|
|
|
John Tattory
|
|
|
Chief Financial Officer
|
Exhibit No.
|
Description
|
Method of Filing
|
|
|
|
|
|
3.1
|
Amended and Restated Certificate of Incorporation filed as of August 1, 2013, including amendments reflected in a Certificate of Amendment to the Restated Certificate of Incorporation of Discovery filed on December 27, 2010, and in a Certificate of Amendment to the Restated Certificate of Incorporation of Discovery filed on October 3, 2011
|
Incorporated by reference to Exhibit 3.1 to Discovery’s Quarterly Report on Form 10-Q, as filed with the SEC on August 8, 2013.
|
|
|
|
|
|
3.2
|
Certificate of Designations, Preferences and Rights of Series A Junior Participating Cumulative Preferred Stock of Discovery, dated February 6, 2004
|
Incorporated by reference to Exhibit 2.2 to Discovery’s Form 8-A, as filed with the SEC on February 6, 2004.
|
|
|
|
|
|
3.3
|
Amended and Restated By-Laws of Discovery, as amended effective September 3, 2009
|
Incorporated by reference to Exhibit 3.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on September 4, 2009.
|
|
|
|
|
|
4.1
|
Shareholder Rights Agreement, dated as of February 6, 2004, by and between Discovery and Continental Stock Transfer & Trust Company
|
Incorporated by reference to Exhibit 10.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 6, 2004.
|
|
|
|
|
|
4.2
|
Warrant Agreement dated December 12, 2008 by and between Kingsbridge Capital Limited and Discovery
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on December 15, 2008.
|
|
|
|
|
|
4.3
|
Form of Warrant to Purchase Common Stock issued in May 2009
|
Incorporated by reference to Exhibit 10.3 to Discovery’s Current Report on Form 8-K, as filed with the SEC on May 8, 2009.
|
|
|
|
|
|
4.4
|
Form of Warrant to Purchase Common Stock issued in February 2010
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 18, 2010.
|
|
|
|
|
|
4.5
|
Warrant Agreement, dated as of April 30, 2010, by and between Discovery and PharmaBio
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on April 28, 2010.
|
|
|
|
|
|
4.6
|
Warrant Agreement dated June 11, 2010 by and between Kingsbridge Capital Limited and Discovery
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on June 14, 2010.
|
|
|
|
|
|
4.7
|
Form of Series I Warrant to Purchase Common Stock issued on June 22, 2010 (Five-Year Warrant)
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on June 17, 2010.
|
Exhibit No.
|
Description
|
Method of Filing
|
|
4.8
|
Warrant Agreement, dated as of October 12, 2010, by and between Discovery and PharmaBio
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on October 13, 2010.
|
|
|
|
|
|
4.9
|
Form of Series I Warrant to Purchase Common Stock issued on February 22, 2011 (Five-Year Warrant)
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 16, 2011.
|
|
|
|
|
|
4.10+
|
Form of Warrant dated February 13, 2013, issued to affiliates of Deerfield Management Co., LLP (Deerfield) under a Facility Agreement dated as of February 13, 2012 between Discovery and Deerfield
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on June 14, 2013.
|
|
|
|
|
|
4.11+
|
Form of Warrant dated December 3, 2013, issued to affiliates of Deerfield Management Co., LLP (Deerfield) on December 3, 2013 under a Facility Agreement dated as of February 13, 2012 between Discovery and Deerfield
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on December 6, 2013.
|
|
|
|
|
|
Employment Agreement dated as of March 21, 2014 between Discovery and John Tattory
|
Filed herewith.
|
||
|
|
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
Filed herewith.
|
||
|
|
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
Filed herewith.
|
||
|
|
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith.
|
||
|
|
|
|
101.1
|
The following consolidated financial statements from the Discovery Laboratories, Inc. Annual Report on Form 10-Q for the quarter ended March 31, 2014, formatted in Extensive Business Reporting Language (“XBRL”): (i) Balance Sheets as of March 31, 2014 (unaudited) and December 31, 2013, (ii) Statements of Operations (unaudited) for the three months ended March 31, 2014 and March 31, 2013, (iii) Statements of Cash Flows (unaudited) for the three months ended March 31, 2014 and March 31, 2013, and (v) Notes to consolidated financial statements.
|
|
Exhibit No.
|
Description
|
Method of Filing
|
|
101.INS
|
Instance Document
|
Filed herewith.
|
|
|
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
Filed herewith.
|
|
|
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
Filed herewith.
|
|
|
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
Filed herewith.
|
|
|
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
Filed herewith.
|
|
|
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Filed herewith.
|
|
|
|
Dated:
April 9, 2014
|
|
By:
|
/s/ Kathryn A. Cole
|
|
|
|
Name:
|
Kathryn A. Cole
|
|
/s/ John A. Tattory
|
|
Title:
|
Senior Vice President, Human Resources
|
|
John A. Tattory
|
Accepted and Agreed to:
|
|
Discovery Laboratories, Inc.
|
||
|
|
|
|
|
Name:
|
|
By:
|
||
Date:
|
|
Name:
|
|
|
SS#:
|
|
Title:
|
|
|
|
No inventions or improvements.
|
|
|
|
|
|
See below: Any and all inventions regarding
|
|
|
|
|
|
Additional sheets attached.
|
|
|
No materials or documents.
|
|
|
|
|
|
See below:
|
|
|
Date
|
|
Date: May 12, 2014
|
/s/ John G. Cooper
|
|
John G. Cooper
|
||
|
President and Chief Executive Officer
|
Date: May 12, 2014
|
/s/ John Tattory
|
|
|
John Tattory
|
|
|
Senior Vice President and Chief Financial Officer
|
|