Description of business and basis of presentation | 9 Months Ended |
Sep. 30, 2013 |
Description of business and basis of presentation | ' |
1. Description of business and basis of presentation |
The accompanying unaudited condensed consolidated financial statements of MannKind Corporation and its subsidiaries (the “Company”), have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These statements should be read in conjunction with the financial statements and notes thereto included in the Company’s latest audited annual financial statements. The audited statements for the year ended December 31, 2012 are included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2012 filed with the SEC on March 18, 2013 (the “Annual Report”). |
In the opinion of management, all adjustments, consisting only of normal, recurring adjustments, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the nine months ended September 30, 2013 may not be indicative of the results that may be expected for the full year. |
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates or assumptions. The more significant estimates reflected in these accompanying financial statements involve assessing long-lived assets for impairment, accrued expenses, including clinical study expenses, valuation of forward purchase contracts, valuation of the facility financing obligation, commitment asset, milestone rights, valuation of stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. |
Business — The Company is a biopharmaceutical company focused on the discovery and development of therapeutic products for diseases such as diabetes. The Company’s lead product candidate, AFREZZA (insulin human [rDNA origin]) inhalation powder, is an ultra rapid-acting insulin therapy that recently completed two additional Phase 3 clinical studies for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. On August 14, 2013, the Company released the results of these Phase 3 clinical studies, both of which met their primary efficacy endpoints and safety objectives. On October 13, 2013, the Company submitted the results of these studies to the U.S. Food and Drug and Administration (“FDA”) as an amendment to its new drug application (“NDA”). The FDA subsequently acknowledged the resubmission and advised the Company that it considers the updated NDA to be a complete class 2 response to the Company’s Completed Response Letter issued in January 2011, and assigned a user fee goal (PDUFA) date of April 15, 2014. |
Basis of Presentation — The Company is considered to be in the development stage as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning, and raising capital. It is costly to develop therapeutic products and conduct clinical studies for these products. From its inception through September 30, 2013, the Company has reported accumulated net losses of $2.2 billion, which include a goodwill impairment charge of $151.4 million and cumulative negative cash flow from operations of $1.7 billion. On December 15, 2013, $115.0 million aggregate principal under the Company’s 3.75% Senior Convertible Notes due 2013 (the “2013 notes”) will become due and payable (see Note 10 — Senior convertible notes). These factors raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties. At September 30, 2013, the Company’s capital resources consisted of cash and cash equivalents of $93.8 million. In addition, the Company expects to sell $40.0 million principal amount of the Company’s 9.75% Senior Convertible Notes due 2019 (the “2019 notes”) to Deerfield (as defined below) under a facility agreement in the fourth quarter of 2013 (see Note 11 — Facility financing agreement). The Company is required, with the funds made available by the purchase of these 2019 notes, to repay the 2013 notes. On September 30, 2013, the Company’s ability to borrow additional amounts under a loan arrangement provided by the Company’s principal stockholder, The Mann Group LLC (“The Mann Group”), terminated. In October 2013, however, the loan arrangement was amended to, among other things, extend the maturity date of the loan until January 5, 2020 and extend the date through which the Company can borrow under the loan arrangement to December 31, 2019 (see Note 13 — Subsequent events). As of October 31, 2013, the Company had $30.1 million principal amount of available borrowings under the loan arrangement, although the Company anticipates using a portion of these available borrowings to capitalize into principal, upon mutual agreement of the parties, accrued interest as it becomes due and payable under the loan arrangement (see Note 9 — Related-party arrangements and Note 13 — Subsequent events). Subsequent to September 30, 2013, the Company received $45.0 million in cash proceeds from the exercise of certain public offering warrants prior to their expiration on October 29, 2013. Based upon the Company’s current expectations, including the expectation that Deerfield will purchase $40.0 million principal amount of 2019 notes in the fourth quarter of 2013 in connection with the repayment of the 2013 notes, management believes the Company’s existing capital resources will enable it to continue planned operations into at least the first quarter of 2014. However, the Company cannot provide assurances that Deerfield will fund the third tranche under the Facility Agreement (as defined below), that the Company will be able to access capital through the ATM Agreements (as defined below) on favorable terms, or at all, or that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. |
Capital resources potentially available to the Company include proceeds from the exercise of warrants issued in its February 2012 public offering, the ATM Agreements and issuance of additional 2019 notes to Deerfield, as more fully described below: |
In February 2012, the Company sold in an underwritten public offering 35,937,500 units at an aggregate price to the public of $86.3 million, with each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock. Net proceeds from this offering were approximately $80.6 million, excluding any future proceeds from the exercise of warrants. The warrants are exercisable at $2.40 per share and expire in February 2016. As of September 30, 2013, the Company had received $4.5 million in cash proceeds from the exercise of the February 2012 public offering warrants, with $47.3 million remaining unexercised. |
On March 18, 2013, the Company entered into at-the-market issuance sales agreements (the “ATM Agreements”) with two sales agents, under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $50.0 million under each ATM Agreement (provided that in no event may the Company issue and sell more than $50.0 million of shares of its common stock under both ATM Agreements in the aggregate) from time to time through either of the sales agents. Neither the Company nor either of the sales agents has any obligation to sell shares of the Company’s common stock under the ATM Agreements. Any sales of common stock made under the ATM Agreements will be made in “at the market” offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”). The Company has not yet issued any shares of its common stock under the ATM Agreements. There can be no assurance that the Company will be able to access capital through the ATM Agreements on a timely basis, or at all. |
On July 1, 2013, the Company entered into a Facility Agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”), providing for the sale of up to $160.0 million of 2019 notes to Deerfield in four equal tranches of $40.0 million principal amount. In connection with the Facility Agreement, on July 1, 2013 the Company also entered into a Milestone Rights Purchase Agreement (the “Milestone Agreement”) with Deerfield Private Design Fund and Horizon Santé FLML SÁRL (“HS” and together with Deerfield Private Design Fund, the “Milestone Purchasers”), pursuant to which, the Company sold the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones including the first commercial sale of an AFREZZA product and the achievement of specified net sales figures (the “Milestone Rights” see Note 11 – Facility financing agreement). |
On July 1, 2013, Deerfield purchased the first tranche of 2019 notes and the Milestone Rights for an aggregate of $40.0 million. The closing of the second tranche of 2019 notes, which was subject to achievement and reporting of certain results from the Company’s two Phase 3 clinical studies of AFREZZA, occurred on September 5, 2013. There can be no assurance that the conditions required for the purchase of the third or fourth tranches of the 2019 notes will be met or met in a timeframe necessary to support the Company’s liquidity needs. |
The Company will need to raise additional capital through the resources identified above or, through the sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, assets sales or other means, in order to continue the development and commercialization of AFREZZA and other product candidates and to support its other ongoing activities. However, the Company cannot provide assurances that such additional capital will be available through any such sources or other sources. |
Fair Value of Financial Instruments — The carrying amounts of certain financial instruments, which include cash equivalents and accounts payable, approximate their fair values due to their relatively short maturities. The fair value of the note payable to related party cannot be reasonably estimated as the Company would not be able to obtain a similar credit arrangement in the current economic environment. |
Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash. As of September 30, 2013 and December 31, 2012, the Company held $93.8 million and $61.8 million, respectively, of cash and cash equivalents, consisting primarily of money market funds of $91.1 million and $60.8 million, respectively, and the remaining in non-interest bearing checking accounts. The fair value of these money market funds was determined by using quoted prices for identical investments in an active market (Level 1 in the fair value hierarchy). |
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The following is a summary of the carrying values and estimated fair values of the 2013 notes, the Company’s 5.75% Senior Convertible Notes due 2015 (the “2015 notes”) and the 2019 notes (in millions). |
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| | September 30, 2013 | | | December 31, 2012 | |
| | Carrying | | | Estimated | | | Carrying | | | Estimated | |
value | fair value | value | fair value |
2013 notes | | $ | 114.9 | | | $ | 114.8 | | | $ | 114.4 | | | $ | 81.9 | |
2015 notes | | $ | 98.2 | | | $ | 106 | | | $ | 97.6 | | | $ | 63.2 | |
2019 notes | | $ | 72.9 | | | $ | 75.7 | | | | — | | | | — | |
The estimated fair value of the 2013 notes was calculated based on quoted prices in an active market (Level 1 in the fair value hierarchy). The estimated fair value of the 2015 notes was calculated based on model-derived valuations whose inputs were observable, such as the Company’s stock price, and non-observable, such as the Company’s longer-term historical volatility (Level 3 in the fair value hierarchy). As there is no current observable market for the 2015 notes, the Company determined the estimated fair value using a convertible bond valuation model within a lattice framework. The convertible bond valuation model combined expected cash outflows with market-based assumptions regarding risk-adjusted yields, stock price volatility and recent price quotes and trading information regarding Company issued debt instruments and shares of common stock into which the notes are convertible. As there is no current observable market for the 2019 notes, the Company determined the estimated fair value using a bond valuation model based on a discounted cash flow methodology. The bond valuation model combined expected cash flows associated with principal repayment and interest based on the contractual terms of the debt agreement discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy). |
As discussed in Note 11 — Facility financing agreement, in connection with the Facility Agreement, the Company issued 2019 notes and Milestone Rights and recorded a commitment asset on July 1, 2013. The estimated fair value of the 2019 notes was calculated using a bond valuation model based on a discounted cash flow methodology. The bond valuation model combined expected cash flows associated with principal repayment and interest based on the contractual terms of the debt agreement discounted to present value using a selected market discount rate of 12% (Level 3 in the fair value hierarchy). The estimated fair value of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy). The expected timing and probability of achieving the milestones, starting in 2014, was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate (17.5%) was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The fair value of the commitment asset was estimated using the income approach by estimating the fair value of the future tranches using a market debt rate (12%) commensurate with the risk of the future tranches and the fair value of the cash expected to be received by the Company and assessing the probability of the commitments being funded in the future based on the operational hurdles required for funding being met (Level 3 in the fair value hierarchy). At September 30, 2013, the carrying value of the Milestone Rights and commitment asset approximates their respective estimated fair values. |
The Company concluded its Common Stock Purchase Agreement with The Mann Group entered into in February 2012 (“The Mann Group Common Stock Purchase Agreement”) (see Note 7 — Common and preferred stock) represented a contingent forward purchase contract that met the definition of a derivative instrument in accordance with ASC 815 Derivatives and Hedging (“ASC 815”). Of the 31,250,000 shares issuable pursuant to The Mann Group Common Stock Purchase Agreement, the portion of the derivative instrument representing 14.7 million shares were recorded as equity (“Equity Portion”) as they met the criteria for equity classification under ASC 815-40 Derivatives and Hedging, Contracts in an Entity’s Own Stock. The remaining 16.5 million shares (“Non-Equity Portion”) required classification outside of equity as the Company did not have sufficient available shares at the time of issuance. The Company revalued the Non-Equity Portion of the forward purchase contract at each reporting date and recorded a fair value adjustment within “Other income (expense).” The estimated fair value of The Mann Group Common Stock Purchase Agreement was based on a forward purchase contract valuation (Level 3 in the fair value hierarchy). The fair value of the forward purchase contract was highly sensitive to the discount applied for lack of marketability and the stock price, and changes in this discount and/or the stock price caused the value of the forward purchase contract to change significantly. The Company recognized the change in fair value of $(336,000) in “Other income (expense)” for the three months ended March 31, 2012. The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract was estimated to be equal to the valuation date stock price minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.06% at March 31, 2012. As the shares which would be received upon settlement were unregistered, the Company applied a discount for lack of marketability of 2.57% at issuance and 1.64% at March 31, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock was publicly traded and the fact that there was no contractual restriction on the unregistered shares being registered. As of and for the nine months ended September 30, 2012, the Company recognized the change in fair value of $12.0 million in “Other income.” The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract is estimated to be equal to the valuation date stock price of $2.40 at issuance and $1.69 at May 17, 2012 (the date at which the Company had sufficient available shares) minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.18% at May 17, 2012. As the shares which would be received upon settlement are currently unregistered, the Company applied a discount for lack of marketability of 10.27% at issuance and 1.67% at May 17, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock is publicly traded and the fact that there is no contractual restriction on the unregistered shares being registered. |
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The following roll-forward provides a summary of changes in fair value of the Company’s Level 3 forward purchase contract (in thousands): |
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| | Three months | | | Nine months | | | | | | | | | |
ended | ended | | | | | | | | |
September 30, 2012 | September 30, 2012 | | | | | | | | |
| | Forward | | | Forward | | | | | | | | | |
Purchase | Purchase | | | | | | | | |
Contract | Contract | | | | | | | | |
Beginning Balance | | $ | — | | | $ | — | | | | | | | | | |
Issuance | | | — | | | | 1,080 | | | | | | | | | |
Adjustments to fair value included in other income | | | — | | | | 12,011 | | | | | | | | | |
Transfers to additional paid-in-capital | | | — | | | | (13,091 | ) | | | | | | | | |
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Ending Balance | | $ | — | | | $ | — | | | | | | | | | |
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Recently Issued Accounting Standards — In February 2013, the FASB issued ASU 2013-02, Comprehensive Income (Topic 220) – Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. These amendments do not change the current requirements for reporting net income or other comprehensive income in the financial statements. These amendments provide for additional disclosure requirements for amounts reclassified out of accumulated other comprehensive income. These amendments are effective prospectively for interim and annual periods beginning after December 15, 2012. Early adoption is permitted. Effective January 1, 2013, the Company adopted the new requirements as set forth in ASU 2013-02 in the disclosure of comprehensive income on the Company’s consolidated financial statements. The adoption of the new requirements did not have a significant impact on the Company’s consolidated financial statements. |
In July 2013, the FASB ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force). The amendments in this ASU provide guidance on the financial statements presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as a liability. The amendments in this ASU do not require new recurring disclosures. The amendments in this ASU are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The Company is evaluating the impact, if any, of the adoption of ASU 2013-11 will have on the Company’s consolidated financial statements. |