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As Of Filer Filing For/On/As Docs:Size Issuer Agent 5/11/07 Targanta Therapeutics Corp S-1 22:437 RR Donnelley/FA
Document/Exhibit Description Pages Size
1: S-1 Registration Statement (General Form) HTML 1.86M
2: EX-3.1 2nd Amended & Restated Certificate of HTML 114K
Incorporation
3: EX-4.2 Amended & Restated Registration Rights Agreement HTML 115K
4: EX-10.1 2005 Stock Option Plan, As Amended HTML 79K
5: EX-10.1.1 Form of Notice of Stock Option Grant HTML 19K
6: EX-10.1.2 Form of Stock Option Agreement HTML 24K
7: EX-10.1.3 Form of Notice of Stock Option Grant for Montreal HTML 21K
Employees
8: EX-10.1.4 Form of Stock Option Agreement for Montreal HTML 24K
Employees
9: EX-10.3 Employment Agreement With Mark Leuchtenberger HTML 53K
10: EX-10.4 Employee Agreement With George Eldridge HTML 52K
11: EX-10.7 Lease Agreement With American Twine Ltd. HTML 203K
Partnership
12: EX-10.7.1 1st Amendment to Lease With American Twine Ltd. HTML 22K
Partnership
13: EX-10.12 Asset Purchase Agreement HTML 173K
14: EX-10.13 Note Issuance Agreement HTML 142K
15: EX-10.14 Senior Secured Convertible Acquisition Note HTML 35K
16: EX-10.15 Omnibus Amendment to Asset Purchase Agreement HTML 36K
17: EX-10.17 Form of Indemnification Agreement HTML 64K
18: EX-10.18 Form of Employee Agreement Re: Non-Competition, HTML 34K
Non-Solicitation
19: EX-10.19 Form of Series C-1 Preferred Stock Warrant HTML 76K
20: EX-10.20 Form of Common Stock Warrant HTML 76K
21: EX-21.1 List of Subsidiaries HTML 8K
22: EX-23.2 Consent of Ernst & Young Llp HTML 9K
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| Form S-1 |
As filed with the Securities and Exchange Commission on May 11, 2007
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
TARGANTA THERAPEUTICS CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 2834 | 20-3971077 | ||
| (State of Incorporation) | (Primary Standard Industrial Classification Code Number) | (I.R.S. Employer Identification Number) |
222 Third Street, Suite 2300
(617) 577-9020
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Chief Executive Officer
Targanta Therapeutics Corporation
222 Third Street, Suite 2300
(617) 577-9020
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)
Copies to:
| William B. Asher, Esq. Brian P. Lenihan, Esq. Lee S. Feldman, Esq. Choate Hall & Stewart LLP Two International Place (617) 248-5000 |
Glenn R. Pollner, Esq. Dewey Ballantine LLP 1301 Avenue of the Americas (212) 259-8000 |
Approximate date of commencement of proposed sale to the public:
As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ¨
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
CALCULATION OF REGISTRATION FEE
| Title of Each Class of Securities to be Registered | Proposed Maximum Aggregate Offering Price(1) |
Amount of Registration Fee(2) | ||||
| Common Stock, $0.0001 par value per share |
$ | 86,250,000 | $ | 2,647.88 | ||
| (1) | Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act. |
| (2) | Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price and includes the offering price of shares that the underwriters have the option to purchase to cover over-allotments, if any. |
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), shall determine.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED MAY 11, 2007
Shares
Common Stock
This is an initial public offering of shares of common stock of Targanta Therapeutics Corporation.
We are selling shares of common stock in this offering.
Prior to this offering, there has been no public market for our common stock. The initial public offering price of the common stock is expected to be between $ and $ per share. We will apply to list our common stock on The Nasdaq Global Market under the symbol “TARG.”
The underwriters have an option to purchase a maximum of additional shares to cover over-allotment of shares.
Investing in our common stock involves risks. See “ Risk Factors” beginning on page 10.
| Price to |
Underwriting |
Proceeds to | ||||
| Per Share |
$ | $ | $ | |||
| Total |
$ | $ | $ |
Delivery of the shares of common stock will be made on or about , 2007.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Sole Book-Running Manager
Credit Suisse
Cowen and Company
Lazard Capital Markets
Leerink Swann & Company
The date of this prospectus is , 2007.
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| SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS |
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| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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| MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX CONSEQUENCES TO NON-U.S. HOLDERS |
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| F-1 |
You should rely only on the information contained in this document or to which we have referred you. We have not authorized anyone to provide you with information that is different. This document may only be used where it is legal to sell these securities. The information contained in this document may only be accurate on the date of this document.
Until , 2007, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to unsold allotments or subscriptions.
Unless the context indicates otherwise, as used in this prospectus, the terms “Targanta,” “we,” “us” and “our” refer to Targanta Therapeutics Corporation and its subsidiaries. The name “Targanta” is our trademark. All other trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners.
PROSPECTUS SUMMARY
This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. You should read this entire prospectus carefully, especially the risks of investing in our common stock discussed under “Risk Factors” beginning on page 10, and the consolidated financial statements and notes to those consolidated financial statements, before making an investment decision.
Overview
We are a biopharmaceutical company focused on the development and commercialization of innovative antibiotics for serious infections treated or acquired in hospitals and other institutional settings. We are developing oritavancin, a novel intravenous antibiotic, for the treatment of serious gram-positive bacterial infections, including complicated skin and skin structure infections, or cSSSI, and bacteremia, an infection caused by bacteria in the bloodstream. Gram-positive bacteria have evolved into strains that are highly resistant to many currently available antibiotics, creating an ever-evolving need for novel antibiotics that employ different mechanisms to control them. According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in U.S. sales in 2006 and this market is rapidly growing.
We expect to submit a new drug application (or NDA) with the United States Food and Drug Administration (or the FDA) seeking to commercialize oritavancin for the treatment of cSSSI in the first quarter of 2008 and hope to receive FDA regulatory approval in late 2008 in the United States and thereafter receive regulatory approval in Europe. We plan on commercializing oritavancin through our own direct sales force in the United States and in select other countries, and to out-license oritavancin to, or collaborate with, third parties in other countries as we deem appropriate. In addition to oritavancin, we have discovered another antibiotic that is currently in pre-clinical development for the treatment of osteomyelitis, and we continually evaluate opportunities for potential in-licensing of other antibiotics for the treatment of hospital-based infections.
We acquired worldwide rights to oritavancin from InterMune, Inc. in late 2005, and believe that since then we have greatly improved its commercial and economic prospects by resolving several important issues with the FDA and by substantially lowering the royalty rate that may be payable to Eli Lilly and Company, the original discoverer of oritavancin. Our strategy is to capitalize on the unique attributes of oritavancin to develop it into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for cSSSI and subsequently for other indications.
Our Lead Product: Oritavancin
Oritavancin is a novel semi-synthetic glycopeptide antibiotic for the treatment of serious gram-positive infections. Oritavancin has completed two Phase 3 studies for the treatment of cSSSI in which the primary end points were successfully met. In addition, oritavancin has completed two Phase 2 trials for the treatment of bacteremia with successful outcomes. Oritavancin is synthetically modified from a naturally occurring compound, and was originally discovered and developed by Lilly to combat a broad spectrum of gram-positive pathogens in response to the emergence of pathogens resistant to vancomycin, the most commonly prescribed antibiotic for resistant gram-positive infections. Oritavancin is protected by intellectual property rights that we licensed from Lilly. The issued oritavancin patents and pending patent applications are part of an extensive world-wide patent estate that includes a composition of matter patent that runs in the United States through November 24, 2015, and, with extension of patent protection available under the Hatch-Waxman Act, we believe may run for up to an additional five years.
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As a glycopeptide (which is a short chain of amino acids with attached sugar molecules), oritavancin shares some properties of other members of the glycopeptide class of antibiotics, which includes vancomycin, the current standard of care for serious gram-positive infections in the U.S. and Europe, as well as telavancin, for which an NDA was submitted in 2006 by Theravance, Inc. However, we believe that oritavancin has advantages compared to other glycopeptides and other classes of gram-positive antibiotics, including the following:
| • | Rapidly Bactericidal and Potentially Less Likely to Engender Resistance. Similar to other glycopeptides, oritavancin disrupts cell wall synthesis by bacteria. However, oritavancin inhibits two separate enzymes involved in cell wall synthesis while most other glycopeptides, including vancomycin, inhibit a single enzyme. Further, oritavancin also causes the rapid rupture of bacterial membranes, leading to significantly faster killing of the bacteria (known as bactericidal activity) as compared to vancomycin and other antibiotics. Taken together, these multiple mechanisms of action may reduce the potential for the emergence of strains of bacteria that are resistant to oritavancin as compared with other antibiotics. To date, no resistant strains have been observed in any clinical trials for oritavancin, and laboratory efforts to cultivate oritavancin-resistant bacteria have proved much less successful than is historically the case with most non-glycopeptide antibiotics. |
| • | Broad Spectrum Against Gram-Positive Bacteria. In-vitro testing indicates that, compared to other antibiotics, oritavancin treats the broadest spectrum of gram-positive pathogens, including organisms resistant to vancomycin and other antibiotics such as linezolid and daptomycin. Unlike vancomycin, in addition to killing actively dividing bacteria, oritavancin has been shown to kill quiescent or non-dividing bacteria, such as those found in biofilm, suggesting potential utility in treating endocarditis, as well as device and catheter related infections. |
| • | Superior In-Vitro Potency. We have performed in-vitro tests on over 8,000 recent bacterial clinical isolates, employing an assay accepted by both the FDA and the Clinical Laboratory Standards Institute (or CLSI), a national standards-developing organization. These tests show that the potency of oritavancin is up to 32 times greater than demonstrated in earlier testing done by Lilly and InterMune and that oritavancin has superior potency against a broad spectrum of gram-positive pathogens compared with tests conducted by us or published data on the potency of other antibiotics. |
| • | Lower Incidence of Adverse Events. Oritavancin has been shown in clinical trials to have a lower rate of adverse events than vancomycin, and its published adverse events rates compare favorably against those published for other antibiotics against resistant gram-positive infections. Unlike other glycopeptides, including vancomycin, telavancin and dalbavancin, oritavancin has not required, in clinical trials to date, monitoring for the purpose of adjusting the blood level of the glycopeptide due to hepatic or renal insufficiency. Further, unlike certain other antibiotics for gram-positive infections, oritavancin did not elevate muscle enzymes, and did not significantly prolong QT interval or cause other electrophysiological changes. |
| • | Favorable Elimination Profile. Unlike many other antibiotics, oritavancin is not metabolized and is slowly eliminated from the body as unchanged drug, substantially reducing the potential for adverse events such as renal toxicity or delayed hypersensitivity that might result from the presence of reactive metabolites. |
| • | Long Half-Life. The in-vivo half-life of oritavancin is significantly longer than the half-lives of most potential competitors. This enables oritavancin to be administered daily, or potentially less frequently. Oritavancin’s Phase 3 trials in cSSSI, for example, tested the compound in a regimen of one dose per day for only three to seven days, substantially less than the labeled or tested regimens of other antibiotics against gram-positive infections. We also believe that a higher dose of the drug may prove effective in treating cSSSI using a single administration, which may be useful in non-hospital institutional settings |
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| such as nursing homes, or for patients being discharged from hospitals. We plan to begin a Phase 2 study in 2007 and a Phase 3 study in 2008 to evaluate a single dose regimen of oritavancin for cSSSI. We believe that azithromycin, a long-acting antibiotic, has demonstrated that a long-acting antibiotic can be commercially successful once clinicians are convinced it has a benign adverse event profile. |
| • | Potential Efficacy in Bacteremia. Oritavancin has completed two Phase 2 studies in bacteremia with successful outcomes, including a Phase 2 study where vancomycin was used as the comparator. Based on these results, we plan to begin a Phase 3 bacteremia study in 2008. Many other antibiotics used against gram-positive pathogens are ineffective against bacteremia or have toxicities that may limit their use for longer durations. |
As a result of these advantages, we believe that oritavancin could provide physicians with an efficacious and novel antibiotic for the treatment of serious gram-positive infections while providing significant pharmoeconomic benefits by reducing the need for patient monitoring and shortening hospital stays.
Oritavancin has been tested in over 1,500 patients and has completed two Phase 3 trials for the indication of cSSSI conducted by Lilly and InterMune. We believe that the completed Phase 3 trials should be sufficient for FDA approval of oritavancin for cSSSI due to the following:
| • | Efficacy. Each Phase 3 clinical trial used a non-inferiority trial design and met the primary endpoint of non-inferiority, which is currently accepted by the FDA as the appropriate trial design for antibiotics that treat serious gram-positive infections. These trials compared oritavancin to an active control arm of vancomycin followed by cephalexin and showed that oritavancin was effective in an average of 5.3 days compared to 10.9 days for vancomycin / cephalexin. |
| • | Safety. In each of these Phase 3 trials, oritavancin was well tolerated and, compared to the control arms, exhibited a favorable safety profile and a lower discontinuation rate due to adverse events. |
| • | Favorable FDA Interactions. The FDA confirmed to us in writing in March 2007 that the non-inferiority design using an active control that was employed in both Phase 3 trials was appropriate for cSSSI. In addition, in three separate meetings, including our pre-NDA meeting on January 31, 2007 in which we specifically discussed the Phase 3 trials, the FDA has not requested that we perform additional clinical trials to demonstrate efficacy in cSSSI. Since the FDA’s accepted delta (difference in cure rates) for non-inferiority trials for antibiotics that treat serious infections like cSSSI (using a comparator like vancomycin) is now 10%, the FDA has requested that we provide justification, as part of our NDA, for the choice of the 15% non-inferiority delta previously accepted by the FDA for the first of these two Phase 3 trials. As part of this analysis, the FDA has requested that we provide information on the non-inferiority margin both in terms of the benefit of oritavancin as compared to historical vancomycin and placebo cure rates and in terms of acceptable loss of treatment effect relative to historical vancomycin and placebo cure rates (in a population as similar as possible to the population enrolled in these Phase 3 clinical trials). The FDA has indicated that this analysis will be critical to approval of our NDA. |
Accomplishments Since We Acquired Oritavancin
We believe that we have greatly improved the commercial and economic prospects for oritavancin since we acquired worldwide rights to it in late 2005 from InterMune because of actions we have taken that include:
| • | Regulatory. We have resolved certain outstanding regulatory issues for oritavancin. We submitted data to the FDA regarding a previous concern that, in two Phase 1 studies conducted by InterMune in 2003, oritavancin had an increased rate of injection-site phlebitis (or vascular inflammation). In January 2007, |
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| the FDA accepted our assessment of the data we had submitted and agreed to lift the voluntary clinical hold originally requested by InterMune in 2004. Further, the FDA did not object to our plan to file our NDA. |
| • | Potency. We have performed in-vitro potency tests on more than 8,000 recent bacterial isolates, employing an assay that has been accepted recently by the FDA and the national standards-developing organization CLSI. These tests show that oritavancin is as much as 32 times more potent than previously shown by Lilly and InterMune and has superior potency against a broad spectrum of gram-positive bacteria compared with tests conducted by us or published data on the potency of other antibiotics. |
| • | Economic. We were able to negotiate a substantially lower royalty obligation to Lilly than would have been payable to Lilly by InterMune, oritavancin’s previous licensee. |
The Gram-Positive Antibiotic Market
There is a growing need for novel antibiotics because bacteria mutate quickly and often develop resistance to existing antibiotics. According to a July 2004 publication by the Infectious Diseases Society of America, approximately 70% of all bacterial infections resulting in hospitalization are now resistant to some form of antibiotic. According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in U.S. sales in 2006. According to IMS Health, the predominant treatment for resistant gram-positive bacteria is vancomycin, which currently accounts for approximately 85% of courses of therapy in the United States for antibiotic-resistant gram-positive pathogens. Use of vancomycin, a generic drug, has been declining in recent years due to its decreasing efficacy against resistant strains of gram-positive bacteria and the emergence of more attractive treatment options. Two other antibiotics comprise the majority of remaining sales in the resistant gram-positive market: Zyvox®, which is known generically as linezolid and marketed by Pfizer; and Cubicin®, which is known generically as daptomycin and marketed by Cubist Pharmaceuticals. However, bacterial resistance has already emerged to both of these drugs.
Based on recent market research we performed, we believe that significant unmet needs remain in the treatment of gram-positive infections. Based on this research, we learned that infectious disease physicians most desired greater efficacy, fewer side effects, fewer treatment issues and shorter hospital stays. We believe that oritavancin has advantages in all of these categories.
Our Strategy
We hold the worldwide rights to oritavancin and our strategy is to develop oritavancin into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for the treatment of cSSSI and subsequently for other indications. Specifically, we plan to:
| • | Obtain regulatory approval for oritavancin for the treatment of cSSSI in the United States; |
| • | Build a hospital-directed sales force to commercialize oritavancin in the United States; |
| • | Pursue clinical development of oritavancin in other dosing regimens and for additional indications; |
| • | Submit a marketing authorization application for oritavancin in the European Union (or the EU) and evaluate the potential for a blended commercialization strategy composed of proprietary sales and partnerships with third parties; |
| • | Out-license oritavancin to third parties for commercialization in key Asian countries; and |
| • | Pursue the development of other innovative antibiotics for the hospital market, either through in-licensing or internal development. |
4
Risks Related to Our Business
Our ability to implement our current business strategy is subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. These risks include, among others, our dependence on the success of oritavancin; delays in obtaining, or a failure to obtain, regulatory approval for our product candidates; failure of any approved product to achieve significant commercial acceptance in the medical community or receive reimbursement by third-party payors; unfavorable clinical trial results; our dependence upon third parties under our licensing, contract research and manufacturing agreements; delays in product launch; and failure to maintain and protect our proprietary intellectual property assets. All of our product candidates are subject to regulatory approval by the FDA and comparable agencies in other countries. Oritavancin is our only product candidate presently in clinical development and has not yet received regulatory approval. We cannot give any assurance that it, or any other product candidates we may develop or acquire, will receive regulatory approval or be successfully commercialized.
We have not generated any revenue to date from product sales and have incurred significant operating losses since our inception in 1997. We incurred net losses of approximately $2.7 million, $5.1 million, and $4.7 million in fiscal years ended May 31, 2003, 2004, and 2005, respectively, $16.1 million for the seven months ended December 31, 2005, and $29.3 million for the year ended December 31, 2006. As of December 31, 2006, we had an accumulated deficit of approximately $61.6 million and we expect to incur losses for the foreseeable future. We are unable to predict the extent of future losses or when we will become profitable, if at all. Even if we succeed in developing and commercializing one or more of our product candidates, we may never generate sufficient revenue to achieve and sustain profitability.
Corporate Information
We are incorporated as a Delaware corporation, effective December 6, 2005, with two subsidiaries in Canada and we initiated operations through our Canadian subsidiary in May 1997 in Montreal, Quebec. In 2006, we relocated our principal executive offices to 222 Third Street, Suite 2300, Cambridge, Massachusetts 02142, where our telephone number is (617) 577-9020. We have additional sites in Indianapolis, Indiana, Montreal, Quebec and Toronto, Ontario. Our web site address is http://www.targanta.com. The information contained in, or that can be accessed through, our website is not part of this prospectus and should not be considered part of this prospectus.
5
THE OFFERING
| Common stock offered by us |
shares |
| Common stock to be outstanding after this offering |
shares |
| Use of proceeds |
We expect to receive net proceeds from the offering of approximately $ million. We intend to use the proceeds from the offering as follows: |
| • | to fund internal and external costs in connection with our anticipated NDA submission for oritavancin in the United States and for other regulatory filings thereafter in Europe; |
| • | to fund clinical trials for oritavancin in cSSSI using a single administration and to continue the clinical development of oritavancin for other indications such as bacteremia; |
| • | to fund commercial launch-related expenses for oritavancin including manufacturing, marketing, and sales in anticipation of regulatory approval; |
| • | to make regularly scheduled payments on existing debt facilities; |
| • | to apply the remaining funds for general corporate purposes and the potential acquisition of, or investment in, technologies, products, or companies that complement our business. |
For further information, see “Use of Proceeds.”
| Proposed Nasdaq Global Market symbol |
“TARG” |
The number of shares of our common stock outstanding following this offering is based on 11,457,760 shares of our common stock outstanding as of April 30, 2007, and excludes:
| • | 2,051,749 shares of our common stock reserved for issuance under our stock plans, of which options to purchase 46,017 shares of our common stock are outstanding at a weighted average price of $50.94 per share; |
| • | the issuance of up to 603,370 shares of our common stock upon the exercise of outstanding warrants at a weighted average price of $13.86 per share, all of which are currently exercisable; and |
| • | shares potentially issuable to InterMune upon our future achievement of a milestone under our agreements with InterMune, consisting of 358,798 shares of our Series C-2 preferred stock and 358,797 shares of our Series C-3 preferred stock, as well as a warrant exercisable for up to 35,553 shares of our Series C-1 preferred stock. |
This number also assumes no exercise of the underwriters’ over-allotment option. If the over-allotment option is exercised in full, we will issue and sell an additional shares of our common stock.
6
Except as otherwise noted, we have presented the information in this prospectus based on the following assumptions:
| • | a 1-for- reverse stock split of our common stock completed immediately prior to the effectiveness of this offering; |
| • | the issuance and sale of shares of our common stock in the offering at the initial public offering price of $ per share; |
| • | the exchange of all outstanding exchangeable shares of our two Canadian subsidiaries into 3,582,805 shares of common stock of the Company, which exchange shall be effected upon the closing of this offering; |
| • | the automatic conversion of all outstanding shares of our preferred stock, including preferred exchangeable shares of our two Canadian subsidiaries, which shares will be exchanged into shares of our preferred stock immediately prior to this offering, into an aggregate of 11,437,530 shares of our common stock and the conversion of outstanding warrants to purchase 603,370 shares of our common stock upon the closing of this offering; |
| • | no exercise by the underwriters of their over-allotment option to purchase additional shares of our common stock in the offering; and |
| • | the filing of our amended and restated certificate of incorporation with the Secretary of State of the State of Delaware and the adoption of our amended and restated by-laws immediately prior to the closing of the offering. |
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SUMMARY CONSOLIDATED FINANCIAL INFORMATION
The following tables present a summary of our historical financial information and pro forma net loss per common share. You should read the following summary financial data in conjunction with “Selected consolidated financial data,” “Management’s discussion and analysis of financial condition and results of operations” and our consolidated financial statements and related notes, all included elsewhere in this prospectus. Pro forma basic and diluted net loss per common share is calculated assuming the automatic conversion of all outstanding shares of our convertible preferred stock, redeemable convertible preferred stock and convertible debt as of December 31, 2006 into an aggregate of 383,036 shares of our common stock. In 2005, we changed our fiscal year end from May 31 to December 31.
| Year Ended 2004 |
Year Ended 2005 |
Seven Months 2005 |
Year Ended 2006 |
For the Period from May 20, 1997 (date of inception) through 2006 |
||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||||||
| Statement of operations data: |
||||||||||||||||||||
| Operating expenses |
||||||||||||||||||||
| Research and development |
$ | 5,198 | $ | 4,503 | $ | 2,319 | $ | 11,456 | $ | 30,747 | ||||||||||
| Acquired in-process research and development |
— | — | 11,847 | — | 11,847 | |||||||||||||||
| General and administrative |
1,506 | 1,388 | 2,114 | 3,678 | 11,461 | |||||||||||||||
| Total operating expenses |
6,704 | 5,891 | 16,280 | 15,134 | 54,055 | |||||||||||||||
| Other income (expense) |
||||||||||||||||||||
| Interest income |
125 | 78 | 31 | 280 | 915 | |||||||||||||||
| Interest expense |
(41 | ) | (211 | ) | (846 | ) | (14,642 | ) | (15,893 | ) | ||||||||||
| Foreign exchange gain (loss) |
— | — | 15 | (214 | ) | (199 | ) | |||||||||||||
| Gain on disposal of property and equipment |
— | — | — | — | 47 | |||||||||||||||
| Other income (expense), net |
84 | (133 | ) | (800 | ) | (14,576 | ) | (15,130 | ) | |||||||||||
| Loss before income tax benefit |
(6,620 | ) | (6,024 | ) | (17,080 | ) | (29,710 | ) | (69,185 | ) | ||||||||||
| Income tax benefit |
1,517 | 1,364 | 1,015 | 384 | 7,592 | |||||||||||||||
| Net loss |
$ | (5,103 | ) | $ | (4,660 | ) | $ | (16,065 | ) | $ | (29,326 | ) | $ | (61,593 | ) | |||||
| Net loss per share—basic and diluted |
$ | (344.16 | ) | $ | (305.33 | ) | $ | (828.72 | ) | $ | (1,596.18 | ) | ||||||||
| Weighted average number of common shares used in net loss per share—basic and diluted |
20,209 | 20,216 | 20,230 | 20,230 | ||||||||||||||||
| Unaudited |
||||||||||||||||||||
| Pro forma net loss per share—basic and diluted |
$ | (120.13 | ) | |||||||||||||||||
| Shares used in computing pro forma net loss per share—basic and diluted |
298,918 | |||||||||||||||||||
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The pro forma balance sheet data as of December 31, 2006 gives effect to the automatic conversion of all outstanding shares of our convertible preferred stock, redeemable convertible preferred stock and convertible debt into an aggregate of 383,036 shares of our common stock upon the closing of this offering and a charge to operations of $8.3 million related to previously unamortized deferred financing costs and debt discounts. The pro forma as adjusted balance sheet data as of December 31, 2006 also gives effect to the sale of shares of common stock offered by this prospectus at the assumed initial public offering price of $ per share, after deducting underwriting discounts and commissions and estimated offering expenses.
| As of December 31, 2006 |
Actual | Pro forma | Pro forma as adjusted | ||||||||
| (in thousands) | |||||||||||
| Balance sheet data: |
|||||||||||
| Cash, cash equivalents and short-term investments |
$ | 12,533 | $ | 12,533 | $ | ||||||
| Working capital (deficit) |
(7,683 | ) | 11,262 | ||||||||
| Total assets |
15,214 | 14,841 | |||||||||
| Note payable |
7,297 | 7,297 | |||||||||
| Convertible debt |
28,516 | — | |||||||||
| Series B redeemable convertible preferred stock |
17,988 | — | |||||||||
| Deficit accumulated during the development stage |
(61,593 | ) | (69,900 | ) | |||||||
| Total stockholders’ (deficit) equity |
(42,291 | ) | 4,852 | ||||||||
The pro forma balance sheet data does not reflect the Series C financing transaction that closed on January 31 and February 16, 2007 or the gross proceeds of that financing of $58.4 million. Giving effect to this transaction as of December 31, 2006, we would have had cash, cash equivalents and short-term investments of $70.9 million and debt balances of $7.3 million.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should consider carefully the risks described below, together with the other information in this prospectus (including our financial statements and the related notes) before investing in our common stock. If any of the following risks actually occur, our business, operating results or financial condition could be materially adversely affected. This could cause the market price of our common stock to decline, and could cause you to lose all or part of your investment.
Risks Related to our Business
We are dependent on the success of our lead product candidate, oritavancin, and we cannot give any assurance that it will receive regulatory approval, which is necessary before it can be commercialized.
Our near-term prospects are substantially dependent on our ability to submit an NDA on a timely basis for our lead product candidate, oritavancin, obtain FDA approval to market oritavancin and successfully commercialize this product. We currently plan to submit an NDA to the FDA in the first quarter of 2008 seeking approval to commercialize oritavancin for the treatment of cSSSI. We will not be able to commercialize oritavancin prior to obtaining FDA approval. Even if we submit an NDA to the FDA on our currently anticipated timeline, we would not expect to receive FDA approval and be able to commercialize this product for at least twelve months after the date of this offering, at the earliest. We cannot assure you that our timeline for filing an NDA for oritavancin will not be delayed, or that we will be able to obtain FDA approval for this product. If we are not able to commercialize oritavancin for cSSSI or for any other indications, we will not be able to generate product revenues in the foreseeable future, or at all. Oritavancin is the only one of our product candidates for which clinical trials have been conducted, and we do not expect to advance any other product candidates into clinical trials until 2009, if at all.
We have limited experience conducting clinical trials, and no prior experience in submitting an NDA to the FDA seeking regulatory approval to commercialize a drug. The two Phase 3 clinical trials that we intend to use in support of our NDA for oritavancin for cSSSI were conducted by our predecessors in the development of this drug. These two Phase 3 trials were designed and conducted as non-inferiority studies in which oritavancin was compared with vancomycin followed by cephalexin, an approved treatment for patients who have serious gram-positive infections. The goal of a non-inferiority study, such as those conducted with respect to oritavancin, is to show that a product candidate is not less effective than the approved treatment.
It is possible that the FDA may refuse to accept our NDA for substantive review or may conclude after review of our data that our application is insufficient to allow approval of oritavancin. If the FDA does not accept or approve our NDA, it may require that we conduct additional clinical, pre-clinical or manufacturing validation studies and submit that data before it will reconsider our application. Depending on the extent of these or any other FDA required studies, approval of any NDA or application that we submit may be delayed by several years, or may require us to expend more resources than we have available. In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent regulatory approval, as well as impose more stringent product labeling and post-marketing testing requirements on pharmaceutical products generally, and particularly in our areas of focus. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing oritavancin or any of our other product candidates, generating revenues, and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve our application. If any of these outcomes occur, we may be forced to abandon our application for approval of oritavancin, which would materially adversely affect our business and could potentially cause us to cease operations.
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We may experience significant delays in the launch of oritavancin for commercialization, which would delay our generation of revenues.
We could experience significant delays in the commercial launch of oritavancin due to many factors, including:
| • | a delay in the filing of our NDA with the FDA, whether as a result of unforeseen delays in compiling clinical trial data from the Phase 3 trials conducted on oritavancin for inclusion in our NDA or otherwise; |
| • | the FDA’s refusal to accept our NDA, any requirement by the FDA that we conduct additional studies to support our NDA or the denial by the FDA of our NDA submission; |
| • | the receipt of unsatisfactory or unexpected results from the additional toxicology testing that we intend to perform as a result of a request from the FDA on existing oritavancin drug product produced by Abbott Laboratories (or Abbott) and Cardinal Health PTS, LLC (or Cardinal), our current suppliers, which results could cause the FDA to refuse to approve our NDA, require us to conduct additional testing, require changes to our manufacturing process or prohibit us from using existing drug product inventory for the commercial launch of oritavancin; |
| • | any requirement by the FDA that the drug product we use for commercial launch contain a reduced level of impurities, which could potentially render our existing drug product inventory unusable for our planned commercial launch and would require us to expend considerable time and expense to replace that inventory for commercial launch, which may be impossible or cost-prohibitive; |
| • | any issues raised by the FDA in connection with its pre-approval inspections of the manufacturing facilities of our contract manufacturing partners, which may result in the FDA’s refusal to approve oritavancin for commercial sale or may require additional manufacturing validation studies or restrictions on operations, any of which would be costly and time consuming and require further FDA review and approval; |
| • | any delay in commencing and completing further Phase 2 and Phase 3 clinical trials of oritavancin for other indications, including for the treatment of cSSSI with a single, larger dose, or for the treatment of other indications; |
| • | the receipt of unsatisfactory or unexpected results from these further clinical trials, which could cause the FDA to require us to perform additional testing or to deny applications that we intend to submit in the future for additional indications for oritavancin; |
| • | a delay in filing required applications with foreign regulatory authorities and any requirement by a foreign regulatory authority that we conduct further clinical trials in order to qualify our application for approval; and |
| • | our failure to establish a sales and marketing force in the time frame that we anticipate and any failure or delay in getting oritavancin listed on hospital and health management organization formularies. |
Any one or a combination of these events could significantly delay, or even prevent, our ability to commercialize oritavancin. If we are not successful in commercializing oritavancin, or if we are significantly delayed in doing so, our business, operating results and financial condition will be materially adversely affected.
Recent FDA and Congressional actions have led to uncertainty as to the standards for obtaining FDA approval of new drugs generally and new antibiotics specifically, and we cannot assure you that the FDA will not either require us to meet new standards in order to obtain approval for commercial sale of oritavancin or require us to demonstrate to the FDA’s satisfaction why trial results under superseded standards are adequate.
In 2006, the FDA, for certain types of antibiotics for certain less serious, typically self-resolving infections, refused to accept successfully completed non-inferiority studies as the basis for approval. Instead, for some
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antibiotic products or trials involving comparator antibiotics, the FDA required placebo-controlled trials demonstrating the superiority of a drug candidate to placebo before considering approval. Conducting placebo-controlled trials for antibiotics can be time-consuming, expensive, and difficult to complete. Institutional review boards may not grant approval for placebo-controlled trials because of ethical concerns about denying some participating patients access to any antibiotic therapy during the course of the trial. Even if institutional review board approval is obtained, it may be difficult to enroll patients in placebo-controlled trials, particularly for infections that are serious and, if left untreated, life-threatening, because certain patients would not receive antibiotic therapy. In addition, the FDA has not indicated whether all antibiotics would require placebo- controlled superiority studies for FDA approval. This lack of guidance creates uncertainties about the standards for approval of antibiotics in the United States.
Moreover, recent events, including complications arising from FDA-approved drugs, have raised questions about the safety of marketed drugs and may result in new legislation by the U.S. Congress and increased caution by the FDA and comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory approvals. In particular, non-inferiority studies have come under scrutiny from Congress, in part because of a congressional investigation as to the safety of Ketek, an antibiotic approved by the FDA on the basis of non-inferiority studies. Certain key members of Congress have asked the U.S. Government Accountability Office, an independent, non-partisan arm of Congress, to investigate the FDA’s reliance on non-inferiority studies as a basis for approval. It is possible that members of Congress may draft and introduce, and that Congress may pass, legislation that could significantly change the FDA’s approval process for antibiotics. If this were to happen, the path to regulatory approval for oritavancin might be significantly delayed.
We believe, based on our communications to date with the FDA, that the FDA will not require placebo-controlled studies to support approval of an NDA for oritavancin for cSSSI. In particular, the FDA has acknowledged that clinical trials relying on a non-inferiority trial design, like the two Phase 3 clinical trials conducted by our predecessors on oritavancin for cSSSI, are the appropriate type of trial design for the study of the safety and efficacy of oritavancin for the treatment of a serious and, if left untreated, life-threatening infection like cSSSI. However, though we have not been asked to date to do so, we cannot assure you that the FDA will not require us to perform additional clinical trials to demonstrate the non-inferiority or superiority of oritavancin as compared either to placebo or to previously approved treatments like vancomycin. In addition, we cannot assure you that the FDA will, when reviewing our NDA submission, consider the results of the two Phase 3 clinical trials of oritavancin sufficient.
If we cannot justify to the FDA the 15% non-inferiority margin used in the first Phase 3 study of oritavancin with respect to oritavancin’s benefit over placebo and its non-inferiority to vancomycin and other approved antibiotics, the FDA may not approve oritavancin without an additional Phase 3 study or at all.
The first of the two Phase 3 studies of oritavancin for cSSSI conducted by our predecessors was designed to demonstrate non-inferiority on primary endpoint with a delta, or difference, in cure rate of 15% between oritavancin and the comparator (a combination of vancomycin followed by cephalexin). A 15% delta was appropriate for this non-inferiority trial at the time the FDA reviewed the protocol design of this Phase 3 trial, which commenced in 1999. The results of this first Phase 3 trial demonstrated oritavancin’s efficacy at the lower bound using a 95% confidence interval to be -14.8%, which was within the non-inferiority delta as compared to the control arm. Although the trial results were within the then accepted 15% non-inferiority delta for this particular clinical trial, new International Conference on Harmonization, or ICH, guidelines now request the sponsor to provide a reliable estimate of the placebo-adjusted cure rate of the control treatment (in our case, vancomycin) in a population similar to that enrolled in the trial, before selecting the non-inferiority margin. In pre-NDA meetings, the FDA has noted that a new retrospective justification by us of a 15% non-inferiority margin, based on the new ICH guidelines, will be a critical element in its review of this Phase 3 clinical trial. We are in the process of compiling materials and information in an effort to apply the new ICH guidelines to support
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retrospectively the 15% non-inferiority margin. If we are unable to identify sufficient materials and information to justify the 15% non-inferiority margin, or if the FDA does not find the materials and information we submit to be persuasive and sufficient to support approval of an NDA or find our justification for the use of a 15% non-inferiority delta compelling, we may be unable to obtain FDA approval for oritavancin without additional clinical trials or at all. Any requirement of the FDA that we conduct an additional Phase 3 study of oritavancin would entail substantial expense and delay, and we cannot assure you in such a case that oritavancin would ever receive FDA approval.
If we are unable to discover, develop or acquire product candidates that are safe and effective, our business will be adversely affected.
We have never commercialized any of our product candidates. Further, we are uncertain whether any of our product candidates will prove effective and safe in humans or meet applicable regulatory standards. Companies in the biotechnology and pharmaceutical industries, including companies with greater experience in pre-clinical testing and clinical trials than we have, have suffered significant setbacks in advanced clinical trials, even after demonstrating promising results in earlier trials. The risk of failure for all of our product candidates is high. The data supporting our drug discovery and development programs is derived solely from laboratory experiments, preclinical studies and clinical studies. Further, we have limited experience conducting clinical trials, and the two Phase 3 clinical trials that we will use in support of the NDA we intend to submit to the FDA later this year for oritavancin for cSSSI were conducted by our predecessors in the development of oritavancin. There can be no assurance that the Phase 3 clinical trials conducted by our predecessors included a sufficiently large population of patients to demonstrate safety and efficacy sufficient for the FDA to approve the dosage levels that will be included in the product label within our NDA submission.
We anticipate performing further clinical trials of oritavancin over the next several years in an effort to establish its efficacy in other indications. Beyond oritavancin, our other compounds remain in the lead identification, lead optimization, preclinical testing and early clinical testing stages. It is, therefore, impossible to predict when or if any of our compounds and product candidates will prove effective or safe in humans or will receive regulatory approval.
In addition to internal development, an element of our strategy is to seek to in-license other innovative antibiotic product candidates from third parties. Our success in executing on this strategy depends upon our ability to identify, select and acquire the right product candidates and products on terms that are acceptable to us. Any product candidate we identify, license or acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities.
If we are unable to discover, develop or acquire medicines that are effective and safe in humans, our business will fail.
The development and testing of our product candidates are subject to extensive regulation, which can be costly and time consuming. Any of our product candidates may encounter unanticipated delays or suffer significant setbacks or fail in later clinical studies.
Product candidates that have shown promising results in early preclinical or clinical studies may subsequently suffer significant setbacks or fail in later clinical studies. Clinical studies involving our product candidates may reveal that those candidates are ineffective, inferior to existing approved medicines, unacceptably toxic or have other unacceptable side effects. Negative or inconclusive results from or adverse medical events during a clinical trial could cause the clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful.
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Clinical testing is expensive, can take many years to complete and its outcome is uncertain. Failure can occur at any time during the clinical trial process. Additionally, the time required to obtain approval by the FDA is unpredictable, but typically takes many years following the commencement of clinical trials. If our clinical studies are substantially delayed or fail to prove the safety and effectiveness of our product candidates, we may not receive regulatory approval of any of our product candidates, and our business, operating results and financial condition will be materially harmed.
Further, we must conduct our clinical trials under protocols that are acceptable to regulatory authorities and to the committees responsible for clinical studies at the hospital sites at which these studies are conducted. We may experience delays in preparing protocols or receiving approval for them that may delay either or both of the start and finish of our clinical trials. In addition, we may receive feedback from regulatory authorities or results from earlier stage clinical studies that require modifications or delays in planned later stage clinical trials or that cause a termination or suspension of our drug development efforts. If we were to encounter any of these types of delays or suspensions, our drug development costs would likely increase and the timeline for our receipt of regulatory approvals would likely be delayed.
We may be required to suspend or discontinue clinical trials due to the occurrence of unacceptable side effects or other safety risks that could preclude or delay approval of our product candidates.
Our clinical trials may be suspended at any time for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to participants.
Many antibiotics produce significant side effects, including severe allergic reaction, decreased blood pressure, suppression of the bone marrow, inflammation, swelling at the site of injection, muscle toxicity, optic and peripheral neuropathies and headaches. In clinical trials performed to date, side effects of oritavancin have included headache, nausea, vomiting, constipation, phlebitis, dizziness, insomnia, diarrhea and histamine reactions such as flushing, wheezing and itching. In addition, future clinical trials could reveal other side effects. The incidence of these or other side effects could cause us to interrupt, delay or halt future clinical trials of our product candidates and could result in the FDA or other regulatory authorities stopping further development of or denying approval of our product candidates for any or all targeted indications. Even if we believe our product candidates are safe, our data is subject to review by the FDA and comparable foreign regulatory authorities, which may disagree with our conclusions. Moreover, though we have clinical trial insurance, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in one of our clinical trials.
In 2004, InterMune, then the developer of oritavancin, requested a voluntary, self-imposed clinical hold on oritavancin prior to completion of two Phase 1 studies (OCSI-007 and OCSI-008) that were performed to evaluate drug-drug interaction and QT interval prolongation. InterMune requested this self-imposed clinical hold in part due to the observance of phlebitis at the infusion site judged to be unexpectedly greater in incidence and severity than anticipated. We have, since our acquisition of the rights to oritavancin from InterMune in December 2005, reexamined the data from all of the clinical trials with oritavancin and determined that the incidence of phlebitis in the clinical trials of oritavancin for cSSSI was not substantially higher than found with treatment with vancomycin or other glycopeptides. Further, we submitted our assessment of this data to the FDA and, at a January 2007 pre-NDA meeting, the FDA accepted our assessment and agreed to lift the voluntary clinical hold on oritavancin. Although we believe that we have satisfactorily resolved this safety concern, we cannot assure you that this historic safety concern or any other safety concerns will not result in significant delays in obtaining regulatory approval of our NDA or more stringent product labeling requirements for the cSSSI indication.
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The regulatory approval process for our product candidates is complex and costly. If oritavancin or the other product candidates that we develop are not approved by regulatory agencies, including the FDA, we will be unable to commercialize them.
Before we can launch our product candidates for commercial distribution, we must provide the FDA and similar foreign regulatory authorities with data from preclinical and clinical studies that demonstrates that our product candidates are safe and effective for a defined indication. Our product candidates may face delays in receiving regulatory approval or may fail to receive regulatory approval at all for many reasons, including the following:
| • | approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change; |
| • | we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for a particular indication; |
| • | the results of clinical trials may not meet the level of statistical significance required by the FDA or other regulatory authorities for approval; |
| • | the FDA or other regulatory authorities may disagree with the design of our clinical trials; |
| • | we may be unable to demonstrate that a product candidate’s benefits outweigh its risks or that it presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial; |
| • | the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials, including our assessment that the incidence of injection-site phlebitis in healthy volunteers in the clinical trials performed by our predecessors on oritavancin for cSSSI (which trials involved a higher dose of oritavancin than the one we will include in our initial NDA submission for oritavancin) was not substantially higher than shown for approved treatment protocols like vancomycin and other glycopeptides; |
| • | the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or to obtain regulatory approval in the U.S. or elsewhere, or may only be sufficient under subsequently superseded regulatory requirements; |
| • | we may encounter difficulty in maintaining contact with patients after treatment, resulting in incomplete clinical trial data; |
| • | we may face delays in patient enrollment and variability in the number and types of patients available for clinical studies; |
| • | clinical trials of our product candidates may result in adverse events, safety issues or side effects relating to our product candidates or their formulation into medicines; and |
| • | the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of manufacturers with which we contract for clinical and commercial supplies. |
We will not obtain regulatory approval for a product candidate in the United States unless and until the FDA approves an NDA. In order to market our medicines outside of the United States, we must obtain separate regulatory approvals in each country unless, in the case of the EU, we follow the centralized approval process. The approval procedure varies among countries and can involve additional testing. Further, the time required to obtain approval from foreign regulatory authorities may differ from that required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. We have not yet submitted an NDA to the FDA or made a comparable submission in any foreign country for any of our product candidates, including oritavancin.
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The FDA or comparable foreign regulatory authorities might decide that our data is insufficient for approval and require additional clinical trials or other studies. Additionally, recent events have raised questions about the safety of marketed drugs and may result in increased cautiousness by the FDA and/or comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory considerations. Further, the FDA and comparable foreign regulatory authorities may decelerate regulatory approvals for new drug candidates and impose more stringent product labeling requirements in an effort to ensure that approved drugs are safe and efficacious. Any delay in obtaining, or any inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates. Further, even if we do receive regulatory approval to market a commercial product, that approval may be subject to limitations on the indicated uses for the approved drug product. It is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain the necessary regulatory approvals for commercialization.
Oritavancin may not be accepted by physicians, patients, third party payors, or the medical community in general.
Even if oritavancin is approved by the relevant regulatory agencies, the commercial success of oritavancin will depend upon its acceptance by physicians, patients, third party payors and the medical community in general. If approved, oritavancin will compete with vancomycin, a relatively inexpensive generic drug that is manufactured by a variety of companies, a number of existing antibiotics manufactured and marketed by major pharmaceutical companies and others, including linezolid (marketed by Pfizer as Zyvox) and daptomycin (marketed by Cubist as Cubicin), and potentially new antibiotics that are not yet on the market. Even if the medical community accepts that oritavancin is safe and efficacious for its approved indications, physicians may not immediately be receptive to the use of oritavancin or may be slow to adopt it as an accepted treatment for gram-positive infections. In the United States and elsewhere, sales of pharmaceutical products depend in significant part on the availability of coverage and reimbursement to providers and the consumer from third-party payors, such as government and private insurance plans. These third-party payors are increasingly challenging and negotiating the prices charged for medical products and services based on their degree of value to the patient. If not added to hospital and managed care organization formularies, oritavancin will not be available for prescription by treating physicians.
If we are unable to demonstrate to physicians that, based on experience, clinical data, side-effect profiles and other factors, oritavancin is preferable to vancomycin and other existing or subsequently-developed anti-infective drugs, we may never generate meaningful revenue from oritavancin. The degree of market acceptance of oritavancin depends on a number of factors, including, but not limited to:
| • | the demonstrated clinical efficacy and safety of oritavancin; |
| • | our ability to educate the medical community about the safety and effectiveness of oritavancin; |
| • | the cost of treatment using oritavancin in relation to alternative treatments, including vancomycin and other generic antibiotics; |
| • | acceptance by physicians and patients of oritavancin as a safe and effective treatment; |
| • | the extent to which oritavancin is approved for inclusion on formularies of hospitals and managed care organizations; |
| • | the reimbursement policies of government and third party payors; |
| • | the perceived advantages of oritavancin over alternative treatments, including its potency, treatment period and side effects as compared to other alternative treatments; |
| • | the clinical indications for which oritavancin is approved; |
| • | the extent to which bacteria develop resistance to oritavancin, thereby limiting its efficacy in treating or managing infections; |
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| • | whether oritavancin is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular infections; |
| • | relative convenience and ease of administration; and |
| • | prevalence and severity of side effects. |
We have incurred operating losses in each year since our inception and expect to continue to incur substantial losses for the foreseeable future.
We have been engaged in discovering and developing compounds and product candidates since May 1997. We only acquired worldwide rights to oritavancin from InterMune in December 2005. To date, we have not generated any product sales revenue from oritavancin or any drug product candidate, and we may never generate revenue from selling pharmaceutical products. Further, even if we are able to commercialize oritavancin or any other product candidate, there can be no assurance that we will ever achieve profitability. As of December 31, 2006, we had an accumulated deficit of approximately $61.6 million.
Assuming we obtain FDA approval, we expect that our expenses will increase as we prepare for the commercial launch of oritavancin and as we conduct further clinical trials on oritavancin for other indications. We also expect that our research and development expenses will continue to increase as we continue to initiate new discovery programs and expand our development programs. As a result, we expect to continue to incur substantial losses for the foreseeable future, and these losses may be increasing. We are uncertain when or if we will be able to achieve or sustain profitability. Failure to become and remain profitable would adversely affect the price of our common stock and our ability to raise capital and continue operations.
If we are unable to generate revenues from any product candidates, including oritavancin, or if we are unable to cost-effectively acquire other drug candidates or drug products, our ability to create long-term shareholder value may be limited.
We have no drug products that have been approved by the FDA. Our product candidate closest to possible commercialization is oritavancin, for which we have not yet filed an NDA and for which we must still seek and receive regulatory approval prior to commercial launch. We do not have any product candidates that will generate revenues in the near term. We note that most drug candidates never make it to the clinical development stage and even those that do make it into clinical development have only a small chance of gaining regulatory approval and becoming a drug product. If we are unable to commercialize any of our current or future drug candidates, including oritavancin, or to acquire any marketable drug products, our ability to create long-term shareholder value will be limited.
In the future, we may seek out opportunities to partner with other companies to acquire rights to other drug candidates or drug products, but there is no guarantee that we will be successful in these efforts. The market to acquire rights to promising drug candidates and drug products is highly competitive, and we would be competing with companies that have significantly more resources and experience than we have. In addition, proposing, negotiating, completing and integrating an economically viable drug product acquisition or license is a lengthy and complex process. We may not be able to acquire or license the rights to additional product candidates and approved products on terms that we find acceptable, or at all.
We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
The biotechnology and pharmaceutical industries are intensely competitive. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. Many of our competitors have greater financial and
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other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis technologies and drug products that are more effective or less costly than oritavancin or any drug candidate that we are currently developing or that we may develop, which could render our technology obsolete and noncompetitive.
The competition in the market for therapeutic products that address infectious diseases is intense. Oritavancin faces competition in the United States from commercially available drugs such as vancomycin, marketed generically by Abbott, Shionogi & Co., Ltd., and others; daptomycin, marketed by Cubist Pharmaceuticals, Inc. as Cubicin; and linezolid, marketed by Pfizer, Inc. as Zyvox. In particular, vancomycin has been a widely used and well known antibiotic for over 40 years and is sold in a relatively inexpensive generic form. Vancomycin, daptomycin and linezolid are all approved treatments for serious gram positive infections such as cSSSI. Further, daptomycin is an approved treatment for bacteremia, linezolid is an approved treatment for nosocomial pneumonia and vancomycin is an approved treatment for both bacteremia and pneumonia.
In addition, Pfizer is seeking FDA approval to market dalbavancin (under the name Zeven®) in the United States, which, according to filings made by Pfizer with the Securities and Exchange Commission, could occur during 2007, and, according to filings made by Theravance with the Securities and Exchange Commission, Theravance is seeking FDA approval to market telavancin in the United States and submitted an NDA for telavancin in 2006. Other drug candidates in development include ceftobiprole (developed by Johnson & Johnson) and iclaprim (developed by Arpida Ltd.), which, if approved, would compete in the intravenous antibiotic market and would target indications such as cSSSI. In addition, oritavancin may face competition from drug candidates currently in clinical development and drug candidates that could receive regulatory approval before oritavancin in countries outside the United States and the European Union.
Our ability to compete successfully will depend largely on our ability to leverage our experience in drug discovery and development to:
| • | discover and develop medicines that are superior to other products in the market; |
| • | attract qualified scientific, product development and commercial personnel; |
| • | obtain patent and/or other proprietary protection for our medicines and technologies; |
| • | obtain required regulatory approvals; and |
| • | successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines. |
Any new medicine that competes with a generic market leading medicine must demonstrate compelling advantages in efficacy, convenience, tolerability and/or safety in order to overcome severe price competition and be commercially successful. If approved, oritavancin must demonstrate these advantages, as it will compete with vancomycin, a relatively inexpensive generic drug that is manufactured by a number of companies, and a number of existing antibiotics marketed by major pharmaceutical companies. We will not achieve our business plan if the acceptance of oritavancin is inhibited by price competition or the reluctance of physicians to switch from existing drug products to oritavancin or if physicians switch to other new drug products, or choose to reserve oritavancin for use in limited circumstances. The inability to compete with existing drug products or subsequently introduced drug products would have a material adverse impact on our operating results.
Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make our product candidates obsolete. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA approval or discovering, developing and commercializing medicines before we do. We are also aware of other companies that may currently be engaged in the discovery of medicines that will compete with the product candidates that we are developing.
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Reimbursement may not be available for oritavancin or our other product candidates, which could make it difficult for us to sell our products profitably.
Market acceptance and sales of oritavancin or our product candidates will depend on reimbursement policies and may be affected by future health care reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels. We cannot be sure that reimbursement will be available for oritavancin or any of our other product candidates. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our products. If reimbursement is not available or is available only to limited levels, we may not be able successfully to commercialize oritavancin or any of our other products.
In both the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. In particular, the Medicare Modernization Act of 2003 added an outpatient prescription drug benefit to Medicare, which became effective on January 1, 2006. Drug benefits under this provision are administered through private plans that negotiate price concessions from pharmaceutical manufacturers. We cannot be certain that oritavancin will successfully be placed on the list of drugs covered by particular health plans, plan formularies, nor can we predict the negotiated price for oritavancin, which will be determined by market factors. With respect to Medicaid, the Deficit Reduction Act of 2005 made several changes to the way pharmacies are reimbursed under Medicaid, most of which went into effect on January 1, 2007, which changes could lead to reduced drug prices. Many states have also created preferred drug lists and include drugs on those lists only when the manufacturers agree to pay a supplemental rebate. If oritavancin is not included on these preferred drug lists, physicians may not be inclined to prescribe it to their Medicaid patients.
As a result of legislative proposals and the trend towards managed health care in the U.S., third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new drugs. They may also refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly-approved drugs, which in turn will put pressure on the pricing of drugs. The availability of numerous generic antibiotics at lower prices than branded antibiotics, such as oritavancin, if it were approved for commercial introduction, may also substantially reduce the likelihood of reimbursement for oritavancin. We expect to experience pricing pressures in connection with the sale of our products due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative proposals.
Our ability to pursue the development and commercialization of oritavancin depends upon the continuation of our license from Lilly.
Our license agreement with Lilly provides us with a worldwide exclusive license to develop and sell oritavancin in fields relating to infectious diseases. Pursuant to the license agreement, we are required to make certain milestone and royalty payments to Lilly. The license rights to oritavancin granted to us could revert to Lilly if we do not continue to use commercially reasonable efforts to develop and commercialize an oritavancin drug product or if we otherwise materially breach the agreement. In addition, either we or Lilly may terminate the license agreement upon the other party’s insolvency or uncured material breach of the agreement. If our license agreement with Lilly were terminated, we would lose our rights to develop and commercialize oritavancin, which would materially and adversely affect our business, results of operations and future prospects.
Even if our product candidates receive regulatory approval, commercialization of these products may be adversely affected by regulatory actions.
Even if we receive regulatory approval, this approval may include limitations on the indicated uses for which we can market our medicines. Further, if we obtain regulatory approval, a marketed medicine and its
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manufacturer are subject to continual review, including review and approval of the manufacturing facilities. Discovery of previously unknown problems with a medicine may result in restrictions on its permissible uses, or on the manufacturer, including withdrawal of the medicine from the market. The FDA and similar foreign regulatory bodies may also implement new standards or change their interpretation and enforcement of existing standards and requirements for the manufacture, packaging or testing of products at any time. If we are unable to comply, we may be subject to regulatory or civil actions or penalties that could significantly and adversely affect our business. Any failure to maintain regulatory approval will limit our ability to commercialize our product candidates, which would materially and adversely affect our business, operating results and financial condition.
We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We have agreements with third-party contract research organizations to provide monitors for and to manage data for our on-going clinical programs. We rely heavily on these parties for execution of our preclinical and clinical studies, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol. We and our contract research organizations are required to comply with current good clinical practices, which are regulations and guidelines enforced by the FDA for all of our products in clinical development. The FDA enforces these good clinical practices regulations through periodic inspections of trial sponsors, principal investigators and trial sites. If we or our contract research organizations fail to comply with applicable good clinical practices regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply with good clinical practices regulations. In addition, our clinical trials must be conducted with product produced under good manufacturing practices regulations, and will require a large number of test subjects. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
Our contract research organizations have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our contract research organizations have an ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors or if we are liquidated.
If any of our relationships with these third-party contract research organizations terminate, we may not be able to enter into arrangements with alternative contract research organizations. If contract research organizations do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
We have recently hired additional contract research organizations to obtain additional resources and expertise to accelerate our progress with regard to on-going clinical programs and the synthesis of clinical trial data for submission with our NDA for oritavancin. Switching or adding additional contract research organizations involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new contract research organization commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our contract research organizations, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our operating results, financial condition or future prospects.
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We will be completely dependent on third parties to manufacture oritavancin, and our commercialization of oritavancin could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of oritavancin or fail to do so at acceptable quality levels or prices.
We do not have the capability to manufacture our own oritavancin active pharmaceutical ingredient (or API). As a result, we have entered into a manufacturing and supply agreement with Abbott to manufacture and supply us with bulk oritavancin API for clinical and commercial purposes. Abbott is our sole provider of our supply of oritavancin API. Pursuant to our agreement with Abbott, Abbott currently stores some oritavancin API at its facilities in Illinois and the FDA has agreed to consider the use by us of oritavancin API produced by Abbott, upon regulatory approval, for commercial launch. It is possible, however, that if and when we receive regulatory approval to market and sell oritavancin, our current supply of oritavancin API may have exceeded its useful life and no longer be appropriate for commercial sale.
In addition, we do not have the capability to package oritavancin finished drug product for distribution to hospitals and other customers. Consequently, we have entered into an agreement with Cardinal to supply us with finished product, to be packaged 100 milligrams in 20 cc vials. Prior to commercial launch, we intend to enter into a similar agreement with an alternate fill/finish drug product supplier for oritavancin so that we can ensure proper supply chain management once we are authorized to make commercial sales of oritavancin. Once finalized, we expect that the selected alternate supplier will provide us with finished drug product, also packaged 100 milligrams in a 20 cc vial. If we receive marketing approval from the FDA, we intend to sell drug product finished and packaged by either Cardinal or this alternate supplier.
We have entered into long-term agreements with each of Abbott and Cardinal. In the case of the agreement with Abbott, either party to this agreement may terminate the agreement with at least two years advance notice if the terminating party determines in good faith that the clinical development and/or commercialization of oritavancin of the bulk drug substance, before or after the first commercial sale made by us, is not technically or commercially feasible or if it is not economically justifiable. After the initial term of this agreement, which extends until December 31, 2014, the agreement automatically renews for successive two year terms unless terminated by either party with at least twelve months’ notice. If we change the specifications for the bulk drug substance Abbott is to produce, or the FDA or another regulatory body requires us to change the manufacturing specification for the bulk drug substance, and that change would increase Abbott’s manufacturing costs, we must reach an agreement with Abbott about how to allocate the costs associated with the change. If we cannot reach agreement, Abbott may refuse to implement the change, or may terminate the agreement. Further, Abbott may terminate this agreement if the FDA has not approved an NDA prior to January 1, 2010. Finally, either we or Abbott may terminate this agreement on 60 days’ written notice in the event of insolvency of or uncured material breach by the other party.
Our agreement with Cardinal provides for an initial three year term continuing until March 27, 2010. Either party may terminate this agreement on 60 days’ written notice in the event of an uncured material breach. In addition, Cardinal may suspend production under this agreement until any outstanding payments are brought current. Finally, either party may terminate this agreement upon the other party’s insolvency. We have not yet entered into a long-term agreement with any alternate fill/finish suppliers, but we intend to do so prior to commercial launch of oritavancin in order to ensure that we maintain adequate supplies of finished drug product.
If, for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them. If Cardinal or any alternate supplier of finished drug product, or in particular, Abbott, experiences any significant difficulties in its respective manufacturing processes for oritavancin API or finished product, we could experience significant interruptions in the supply of oritavancin. Our inability to coordinate the efforts of our third party manufacturing partners, or the lack of capacity available at our third party manufacturing partners, could impair our ability to supply oritavancin at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to qualify a new bulk or finished
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product supplier, if we face these or other difficulties with our current suppliers, we could experience significant interruptions in the supply of oritavancin if we decided to transfer the manufacture of oritavancin to one or more alternative suppliers in an effort to deal with the difficulties.
We cannot guarantee that Abbott, Cardinal or alternative manufacturers will be able to reduce the costs of commercial scale manufacturing of oritavancin over time. If the manufacturing costs of oritavancin remain at current levels, these costs may significantly impact our operating results. In order to reduce costs, we may need to develop and implement process improvements. However, in order to do so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such regulatory authorities. We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion. We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process. If we cannot enhance and optimize output, we may not be able to reduce our costs over time.
We believe we have sufficient quantities of manufactured drug substance and have contracted with Cardinal to formulate drug product to complete all of the currently planned clinical studies of oritavancin. Further, we plan to have Abbott, Cardinal and any alternate suppliers later identified manufacture and package additional bulk drug substance and finished drug product in connection with commercial launch in the event oritavancin is approved for sale by regulatory authorities. If we are unable to do so in a timely manner, the commercial introduction of oritavancin, if approved by the FDA, would be adversely affected.
If the FDA does not approve the manufacturing facilities of Abbott, Cardinal or any later identified manufacturing partners, we may be unable to develop or commercialize oritavancin.
We rely on Abbott and Cardinal to manufacture bulk oritavancin API and finished drug product, respectively, and currently have no plans to develop our own manufacturing facility. In addition, we expect to add an alternate fill/finish provider prior to commercial launch of oritavancin. The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA, which inspections will be completed after we submit our NDA to the FDA. We do not control the manufacturing process of oritavancin and are completely dependent on our contract manufacturing partners—currently, Abbott and Cardinal—for compliance with the FDA’s requirements for manufacture of finished oritavancin drug product. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA’s strict regulatory requirements, they will not be able to secure FDA approval for the manufacturing facilities. If the FDA does not approve these facilities for the manufacture of oritavancin, we may need to find alternative manufacturing facilities, which would result in significant delays of up to several years in obtaining approval for and manufacturing oritavancin.
In addition, our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with current Good Manufacturing Practices, or cGMPs, and similar regulatory requirements. These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our product candidates. We do not have control over our contract manufacturers’ compliance with these regulations and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market our product candidates, delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market our product candidates.
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In order to satisfy regulatory authorities, we may need to reformulate the way in which our oritavancin API is created to remove animal source product.
Presently, our oritavancin API is manufactured using animal source product—namely porcine source product. Certain non-US regulatory authorities have historically objected to the use of animal source product—particularly bovine source product—in manufactured drug product. As a result and in order to best position oritavancin for approval in foreign jurisdictions, we have entered into an agreement with Abbott whereby we, along with Abbott, are seeking to develop a manufacturing process for oritavancin API that does not rely on the use of any animal source product.
Although we believe that we can develop a manufacturing process for oritavancin API that does not rely on the use of animal source product, there can be no assurance that we, along with Abbott, will be successful in this endeavor. If we are unable to remove animal source product from the manufacturing process for oritavancin API, it is possible that we will be unable to receive regulatory authority for oritavancin in certain foreign jurisdictions, which would likely have a negative impact on our ability to achieve our business objectives.
We may encounter delays in filling customer orders or incur substantial losses if our supply of bulk and finished drug product, which are produced and packaged for us by third party manufacturers, is interrupted.
Once Abbott has completed production of oritavancin bulk drug product at its facilities in Illinois, the product is shipped to Cardinal’s facilities in Arizona for processing, packaging and labeling as final drug product. These shipments are of significant value and, while in transit, could be lost or damaged. Moreover, at any time after being shipped, our oritavancin API or finished drug product could be lost or damaged as it is stored with Cardinal, our current finished product manufacturer, or, additionally, in the future, when it is stored at the facilities of any alternate fill/finish supplier. Depending on when in this process the API or finished drug product is lost or damaged, we may have limited recourse for recovery manufacturers or insurers. As a result, our financial performance could be impacted by any such loss of or damage to our oritavancin API.
We also may experience interruption or significant delay in the supply of oritavancin API or finished drug product due to natural disasters, acts of war or terrorism, shipping embargoes, labor unrest or political instability. In any such event, the supply of oritavancin API stored at Abbott and the oritavancin finished drug product stored with Cardinal or any alternate fill/finish supplier could also be impacted. We may also be subject to financial risk from volatile fuel costs associated with shipping oritavancin API or finished drug product within the United States and, once we have received necessary foreign approvals, to our international distribution partners for packaging, labeling and distribution.
If we fail to obtain the capital necessary to fund our operations, we may be unable to develop our product candidates and we could be forced to share our rights to commercialize our product candidates with third parties on terms that may not be favorable to us.
We need large amounts of capital to support our research and development efforts. If we are unable to secure capital to fund our operations, we will not be able to continue our discovery and development efforts and we might have to enter into strategic collaborations that could require us to share commercial rights to our products and product candidates with third parties in ways that we currently do not intend. Based on our current operating plans, and after giving effect to the receipt of the net proceeds of this offering, we believe that our cash and cash equivalents and marketable securities will be sufficient to meet our anticipated operating needs into 2009. Depending on the status of regulatory approval or, if approved, commercialization of oritavancin, as well as the progress we make in selling that product candidate, we may require additional capital to fund operating needs thereafter.
Further, we are party to a license agreement with Lilly pursuant to which we are obligated to make certain cash milestone payments to Lilly upon the receipt of certain regulatory approvals of our oritavancin product. In
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addition, we are required to make certain cash royalty payments upon our achievement of target levels of commercial sales of our oritavancin product. We are also obligated to make a future cash milestone payment to InterMune upon our receipt from the FDA of all approvals necessary for the commercial launch of oritavancin. Though we believe that these royalty rates and milestone payments are reasonable in light of our business plan, we will require large amounts of capital to satisfy these obligations.
We may also need to raise additional funds sooner if we choose to expand more rapidly than we presently anticipate. To raise additional funds, we may seek to sell additional equity or debt securities, or both, or incur other indebtedness. The sale of additional equity or debt securities, if convertible, could result in the issuance of additional shares of our capital stock and could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our common stock to fall.
We currently have no sales organization. If we are unable to establish satisfactory sales and marketing capabilities, we may not succeed in commercializing oritavancin.
At present, we have no sales personnel and a limited number of marketing personnel. In anticipation of receiving FDA approval for the commercial launch of oritavancin, we anticipate beginning to hire additional sales and marketing personnel to establish our own sales and marketing capabilities in the United States in time for our anticipated commercial launch of oritavancin. We plan to add our first sales representatives in the first quarter of 2008. Therefore, at the time of our anticipated commercial launch of oritavancin, assuming regulatory approval of the drug by the FDA, our sales and marketing team will have worked together for only a limited period of time. We cannot guarantee that we will be successful in marketing oritavancin in the United States.
We may not be able to establish a direct sales force in a cost effective manner or realize a positive return on this investment. In addition, we will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize our products without strategic partners or licensees include:
| • | our inability to recruit and retain adequate numbers of effective sales and marketing personnel; |
| • | the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products; |
| • | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
| • | unforeseen costs and expenses associated with creating an independent sales and marketing organization. |
If appropriate regulatory approvals are obtained, we intend to commercialize oritavancin and our other product candidates in international markets through collaboration arrangements with third parties. We have not yet entered into any agreements related to the marketing of oritavancin or any of our other product candidates in international markets and we may not be able to enter into any arrangements with respect to international collaborations on favorable terms or at all. In addition, these arrangements could result in lower levels of income to us than if we marketed our product candidates entirely on our own. If we are unable to enter into appropriate marketing arrangements for our product candidates in international markets, we may not be able to develop an effective international sales force to successfully commercialize oritavancin and our other product candidates in
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international markets. If we fail to enter into marketing arrangements for our products and are unable to develop an effective international sales force, our ability to generate revenue would be limited as a significant portion of the market opportunity for oritavancin and our other product candidates is likely to be in international markets.
If we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure or if we do not successfully enter into appropriate collaboration arrangements with third parties, we will have difficulty commercializing oritavancin and our other product candidates, which would adversely affect our business, operating results and financial condition.
A variety of risks associated with our international business relationships could materially adversely affect our business.
If approved for commercialization, we expect oritavancin to be marketed worldwide. Consequently, we expect that we will be subject to additional risks related to operating in foreign countries including:
| • | differing regulatory requirements for drug approvals in foreign countries; |
| • | the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally; |
| • | unexpected changes in tariffs, trade barriers and regulatory requirements; |
| • | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
| • | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
| • | foreign taxes, including withholding of payroll taxes; |
| • | foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
| • | workforce uncertainty in countries where labor unrest is more common than in the United States; |
| • | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
| • | business interruptions resulting from geo-political actions, including war and terrorism. |
These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.
In order to establish our sales and marketing infrastructure, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
As of April 30, 2007, we employed 72 employees. As our development and commercialization plans and strategies develop, we expect to need to expand the size of our employee base for managerial, operational, sales, marketing, financial and other resources. Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate and integrate additional employees. Also, our management may have to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. Our future financial performance and our ability to commercialize oritavancin and our other product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.
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If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our ability to compete in the highly competitive biotechnology and pharmaceuticals industries depends in large part upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific and medical personnel. In order to induce valuable employees to remain at Targanta, we have provided options that vest over time. The value to employees of options that vest over time is significantly affected by movements in our stock price that we cannot control and may at any time be insufficient to counteract more lucrative offers from other companies.
Our scientific team has expertise in many different aspects of drug discovery and development. We conduct our operations at our facilities in Cambridge, Massachusetts, Indianapolis, Indiana and Montreal, Québec, Canada. These areas are headquarters to many other biopharmaceutical companies and many academic and research institutions and, as a result, there is currently a shortage of experienced scientists, which is likely to continue. Competition for skilled personnel in our market is very intense and competition for experienced scientists may limit our ability to hire and retain highly qualified personnel on acceptable terms.
Despite our efforts to retain valuable employees, members of our management, scientific and medical teams may terminate their employment with us on short notice. While we have employment agreements with certain of our employees, these employment arrangements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. The loss of the services of any of our executive officers or other key employees could potentially harm our business, operating results or financial condition. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level, and senior managers as well as junior, mid-level, and senior scientific and medical personnel.
Other biotechnology and pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we have to offer. If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can discover, develop and commercialize drug candidates will be limited.
We may acquire additional businesses or form strategic alliances in the future, and we may not realize the benefits of such acquisitions.
We may acquire additional businesses or products, form strategic alliances or create joint ventures with third parties that we believe will complement or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture. We may have difficulty in developing, manufacturing and marketing the products of a newly acquired company that enhances the performance of our combined businesses or product lines to realize value from expected synergies. We cannot assure that, following an acquisition, we will achieve the revenues or specific net income that justifies the acquisition.
Risks Related to Legal Uncertainty
If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies. Any involuntary disclosure to or misappropriation by third
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parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.
As of March 31, 2007, through our license agreement with Lilly, we licensed from Lilly 35 issued United States patents, three pending United States patent applications, approximately 460 granted foreign patents and approximately 95 foreign national patent applications. We also have three pending United States patent applications filed in relation to aspects of oritavancin discovered by our scientists. After patents related to the composition of oritavancin expire on November 24, 2015, we will not be able to use those patents to block others from marketing oritavancin. We believe, however, that under Hatch-Waxman legislation, the composition of matter patents covering oritavancin may be eligible to be extended for up to an additional five years. Third parties may challenge the patents we license. Further, the patent applications that we license may fail to result in issued patents. Further, the existing or future patents to which we have rights based on our agreement with Lilly may be too narrow to prevent third parties from developing or designing around these patents. If the sufficiency of the breadth or strength of protection provided by the patents we license with respect to oritavancin or the patents we pursue related to another product candidate is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, oritavancin and our other product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could market our drug candidates under patent protection would be reduced.
In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, for processes for which patents are difficult to enforce and for any other elements of our drug discovery and development processes that involve proprietary know-how, information and technology that is not covered by patents. Although we require all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information and technology to enter into confidentiality agreements, we cannot be certain that this know-how, information and technology will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States and Canada. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or, if established, maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.
Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.
Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third party patents with claims to materials, methods of manufacture or methods for treatment related to the use or manufacture of oritavancin and/or our other product candidates. Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third party patents with claims to materials, methods of manufacture or methods for treatment related to the use or manufacture of oritavancin and/or our other product candidates. At present, we are not aware of any patent claims with merit that would adversely and materially affect our ability to develop our product candidates. We are, however, aware of two U.S. patents, and European, Australian, Korean, Canadian and Japanese counterpart patents, with claims to naturally occurring molecules that may be produced in trace amounts as contaminants during the manufacture of oritavancin. Derivatives of these molecules may also be present in the final oritavancin product. Based on our review of these patents and their issued claims, we do not believe that their existence would block our ability to manufacture or commercialize oritavancin, assuming we receive regulatory approval
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to market oritavancin. Furthermore, both of the U.S. patents will expire by the end of December 2008, and each of the counterpart foreign patents will expire by the end of March 2008. Thus, it is likely that at least one, if not both, of the U.S. patents, as well as their corresponding foreign equivalents, will be expired by the time we obtain approval to market oritavancin. We cannot rule out the possibility of third party allegations related to these or any other patents. If these or any other patents were held by a court of competent jurisdiction to cover the oritavancin manufacturing process, any molecules formed during the manufacturing process or the final oritavancin product itself, the holders of any such patents may be able to block our ability to commercialize oritavancin unless we obtained a license under the applicable patent or patents, or until such patents expire. We cannot predict whether we would be able to obtain a license on commercially reasonable terms, if at all. Any inability to obtain such a license under the applicable patents on commercially reasonable terms, or at all, may have a material adverse effect on our ability to commercialize oritavancin until such patents expire.
In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Furthermore, parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, obtain one or more licenses from third parties or pay royalties. In addition, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates, and we have done so from time to time. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize one or more of our product candidates, which could harm our business significantly.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive and time consuming.
Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.
Interference proceedings brought by the U.S. Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications or those of our collaborators or licensors. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management. We may not be able to prevent, alone or with our licensors, misappropriation of our proprietary rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.
The risk that we may be sued on product liability claims is inherent in the development of pharmaceutical products. These lawsuits may divert our management from pursuing our business strategy and may be costly to
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defend. In addition, if we are held liable in any of these lawsuits, we may incur substantial liabilities and may be forced to limit or forgo further commercialization of those products.
Although we maintain general liability and product liability insurance, this insurance may not fully cover potential liabilities. In addition, inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercial production and sale of our products, which could adversely affect our business, operating results and financial condition.
If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
Our research and development activities involve the controlled use of potentially hazardous substances, including chemical, biological and radioactive materials and viruses. In addition, our operations produce hazardous waste products. Federal, state and local laws and regulations in both the United States and Canada govern the use, manufacture, storage, handling and disposal of hazardous materials. Although we believe that our procedures for use, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur significant additional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials and we may incur liability as a result of any such contamination or injury. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, operating results and financial condition.
General Company Related Risks
Our stock price may be volatile, and the value of our stock could decline.
The trading price of our common stock is likely to be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:
| • | any delay in filing our NDA for oritavancin and any adverse development or perceived adverse development with respect to the FDA’s review of the NDA, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information; |
| • | failure to meet or exceed revenue and financial projections we provide to the public; |
| • | actual or anticipated variations in quarterly operating results; |
| • | failure to meet or exceed the estimates and projections of the investment community; |
| • | adverse results or delays in clinical trials; |
| • | changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals; |
| • | our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial; |
| • | inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices; |
| • | developments concerning our collaborations, including but not limited to those with our sources of manufacturing supply and our international commercialization partners; |
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| • | the termination of a collaboration or the inability to establish additional collaborations; |
| • | adverse regulatory decisions; |
| • | unanticipated serious safety concerns related to the use of oritavancin or any of our other product candidates; |
| • | introduction of new products or services offered by us or our competitors; |
| • | announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; |
| • | disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; |
| • | our failure to commercialize oritavancin, develop additional drug candidates and commercialize additional drug products; |
| • | additions or departures of key scientific or management personnel; |
| • | issuances of debt or equity securities; |
| • | significant lawsuits, including patent or stockholder litigation; |
| • | changes in the market valuations of similar companies; |
| • | sales of our common stock by us or our stockholders in the future; |
| • | trading volume of our common stock; and |
| • | other events or factors, many of which are beyond our control. |
In addition, the stock market in general, and The Nasdaq Global Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against companies. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.
If you purchase our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares.
The initial public offering price is substantially higher than the net tangible book value per share of our common stock. Investors purchasing common stock in this offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtracting our liabilities. As a result, investors purchasing common stock in this offering will incur immediate dilution of $ per share, based on an initial public offering price of $ per share. Further, investors purchasing common stock in this offering will contribute approximately % of the total amount invested by stockholders since our inception, but will own only approximately % of the shares of common stock outstanding.
This dilution is due to our investors who purchased shares prior to this offering having paid substantially less than the price offered to the public in this offering when they purchased their shares and the exercise of stock options granted to our employees. In addition, as of April 30, 2007, options to purchase 46,017 shares of our common stock at a weighted average exercise price of $50.94 per share and warrants exercisable for up to 603,370 shares of our common stock at a weighted average price of $13.86 per share were outstanding. The exercise of any of these options or warrants would result in additional dilution. As a result of the dilution to investors purchasing shares in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of a liquidation of our Company.
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We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act, as well as rules subsequently implemented by the Securities and Exchange Commission and The Nasdaq Global Market have imposed various new requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these new compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. In particular, we will be required to perform system and process evaluation and testing of our internal controls over financial reporting to allow management and our independent registered public accounting firm to report, commencing in our annual report on Form 10-K for the year ending December 31, 2008, on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our testing, or the subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses. Our compliance with Section 404 will require that we incur substantial accounting expense and expend significant management efforts. We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge. Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner or if we or our independent registered public accounting firm identifies deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by Nasdaq, the Securities and Exchange Commission or other regulatory authorities, which would require additional financial and management resources.
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.
Substantially all of our existing stockholders are subject to lock-up agreements with the underwriters of this offering that restrict the stockholders’ ability to transfer shares of our common stock for at least 180 days from the date of this prospectus. The lock-up agreements limit the number of shares of common stock that may be sold immediately following the public offering. Subject to certain limitations, approximately 11,374,901 of our total outstanding shares will be eligible for sale upon expiration of the lock-up period. In addition, shares issuable upon exercise of options and warrants vested as of the expiration of the lock-up period will be eligible for sale at that time. Sales of stock by these stockholders could have a material adverse effect on the trading price of our common stock.
Certain holders of shares of our common stock are entitled to rights with respect to the registration of their shares under the Securities Act of 1933, as amended (or the Securities Act), subject to the 180-day lock-up arrangement described above. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
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Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to existing stockholders.
Pursuant to our 2007 Equity Incentive Plan, our management is authorized to grant stock options to our employees, directors and consultants. The number of shares available for future grant under our 2007 Equity Incentive Plan will automatically increase each year by an amount equal to 3.5% of all shares of our capital stock outstanding as of January 1st of each year, subject to the ability of our board of directors to take action to reduce the size of such increase in any given year.
All of the shares of common stock sold in our initial public offering will be freely tradable without restrictions or further registration under the Securities Act, as amended, except for any shares purchased by our affiliates as defined in Rule 144 under the Securities Act. Rule 144 defines an affiliate as a person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, us and would include persons such as our directors and executive officers.
We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
Our management will have broad discretion in the application of the net proceeds, including for any of the purposes described in the section entitled “Use of Proceeds.” The failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
Under Section 382 of the Internal Revenue Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We believe that, with our initial public offering, our most recent private placement and other transactions that have occurred over the past three years, we have triggered an “ownership change” limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership.
Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders.
Provisions in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders. These provisions include:
| • | authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval; |
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| • | limiting the removal of directors by the stockholders; |
| • | creating a staggered board of directors; |
| • | prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; |
| • | eliminating the ability of stockholders to call a special meeting of stockholders; |
| • | permitting our board of directors to accelerate the vesting of outstanding option grants upon certain transactions that result in a change of control; and |
| • | establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings. |
In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our board of directors. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.
Our officers and directors and other affiliates may be able to exert significant control over the company.
After this offering, our executive officers, directors, 5% stockholders and their affiliates will control approximately % of our outstanding common stock. Therefore, these stockholders will have the ability to influence the company through this ownership position.
These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporation transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
Our corporate compliance program cannot ensure that we are in compliance with all applicable “fraud and abuse” laws and regulations and other applicable laws and regulations in the jurisdictions in which we sell oritavancin or other product candidates, and a failure to comply with these regulations or prevail in litigation related to noncompliance could harm our business.
Our general operations, and the research, development, manufacture, sale and marketing of our products, are subject to extensive laws and regulation, including but not limited to, health care “fraud and abuse” laws, such as the federal false claims act, the federal anti-kickback statute, and other state and federal laws and regulations. While we have developed and implemented a corporate compliance program based upon what we believe are current best practices, we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS
This prospectus contains forward-looking statements. Forward-looking statements relate to future events or our future financial performance. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, results of operations and financial condition. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in “Risk Factors” and elsewhere in this prospectus. Accordingly, you should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. We have identified below some important factors that could cause our forward-looking statements to differ materially from actual results, performance or financial condition:
| • | the timing of regulatory filings and approvals; |
| • | the initiation, timing, progress and results of our drug discovery efforts, preclinical studies, clinical trials and other development efforts; |
| • | our ability to advance product candidates into clinical trials; |
| • | the further clinical development and commercialization of our product candidates; |
| • | the implementation of our business model, strategic plans for our business and product candidates; |
| • | the loss of key personnel; |
| • | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; |
| • | our ability to operate our business without infringing the intellectual property rights of others; |
| • | estimates of our expenses, future revenues, capital requirements and our needs for additional financing, as well as the availability of necessary financing on attractive terms; |
| • | assuming regulatory approval and commercialization of our product candidates, market acceptance of the products we develop; |
| • | our use of proceeds from this offering; |
| • | our financial performance; |
| • | competitive companies, technologies and our industry; and |
| • | other factors discussed elsewhere in this prospectus. |
The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events, new information, future earnings or otherwise.
This prospectus also contains market data related to our business and industry. This market data includes projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by this data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, results of operations and financial condition and the market price of our common stock.
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USE OF PROCEEDS
We will receive net proceeds of approximately $ million from the sale of shares of common stock at the assumed initial public offering price of $ per share, after deducting underwriting commissions and discounts of $ million and estimated expenses of $ million. A $1.00 increase (decrease) in the assumed initial public offering price of $ would increase (decrease) the net proceeds to us from this offering by $ , assuming the number of shares offered by us, as set forth on the cover of this prospectus remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise their over-allotment option in full, then the net proceeds will be approximately $ million.
The principal purposes of this offering are to obtain additional capital, to create a public market for our common stock and to facilitate our future access to the public equity markets. We anticipate using the net proceeds from this offering:
| • | to fund internal and external costs in connection with our anticipated NDA submission for oritavancin in the United States and for other regulatory filings thereafter in Europe; |
| • | to fund clinical trials for oritavancin in cSSSI using a single administration and to continue the clinical development of oritavancin for other indications such as bacteremia; |
| • | to fund commercial launch-related expenses for oritavancin including manufacturing, marketing, and sales, in anticipation of regulatory approval; |
| • | to make regularly scheduled payments on existing debt facilities; |
| • | to apply the remaining funds for general corporate purposes and the potential acquisition of, or investment in, technologies, products, or companies that complement our business. |
We have no current understandings, commitments, or agreements with respect to any acquisition of or investment in any technologies, products, or companies.
The amounts and timing of our actual expenditures will depend upon numerous factors, including whether we obtain FDA approval for oritavancin and, if so, the timing of such approval, the success of the commercial launch of oritavancin if approved by the FDA, our cash flows from operations and the anticipated growth of our business. Management will have significant flexibility in applying the net proceeds from this offering. See “Risk Factors—Risks Related to this Offering.” Pending any use, the net proceeds of this offering will be invested in short-term, interest-bearing investment-grade securities.
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DIVIDEND POLICY
Our board of directors will have discretion in determining whether to declare or pay dividends, which will depend upon our financial condition, results of operations, capital requirements and such other factors as the board of directors deems relevant. We currently anticipate that we will retain any future earnings for the development, operation and expansion of our business and do not anticipate paying dividends in the foreseeable future. Moreover, our loan agreement relating to our credit facility with Investissement Québec imposes restrictions on our ability to declare and pay dividends. We may also incur future indebtedness that will limit our ability to declare and pay dividends.
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CAPITALIZATION
The following table sets forth our capitalization as of December 31, 2006:
| • | on an actual basis; |
| • | on a pro forma basis to give effect, upon the closing of this offering, to the conversion of 15,643 shares of our series A convertible preferred stock and 140,744 shares of our series B redeemable convertible preferred stock, which includes 25,575 shares which represent the accumulated dividend associated with the series B redeemable convertible preferred stock, as well as the conversion of our convertible debt, into equity securities convertible into 226,649 shares of common stock and into an aggregate of 383,036 shares of common stock upon the closing of this offering, as well as a charge to operations of $8.3 million related to previously unamortized deferred financing costs and debt discounts; and |
| • | on a pro forma as adjusted basis to give effect to the sale by us of shares of common stock at an assumed initial public offering price of $ per share, after deducting underwriting discounts and commissions and estimated offering expenses. |
You should read the following table in conjunction with our consolidated financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.
| As of December 31, 2006(2) | ||||||||||
| Actual | Pro Forma | Pro Forma As Adjusted | ||||||||
| (in thousands, except share and per share data) | ||||||||||
| Cash, cash equivalents and short-term investments |
$ | 12,533 | $ | 12,533 | ||||||
| Note payable |
7,297 | 7,297 | ||||||||
| Long-term portion of convertible notes |
9,571 | — | ||||||||
| Warrants to purchase shares subject to redemption |
1,012 | — | ||||||||
| Deferred rent |
45 | 45 | ||||||||
| Series B redeemable convertible preferred stock, par value $0.0001 per share, 455,333 shares authorized, 115,169 shares issued and outstanding, actual; no shares authorized, issued or outstanding, on a pro forma basis or on a pro forma as adjusted basis |
17,988 | — | ||||||||
| Stockholders’ (deficit) equity: |
||||||||||
| Series A convertible preferred stock, par value $0.0001 per share, 16,667 shares authorized, 15,643 shares issued and outstanding, actual; no shares authorized, issued or outstanding, on a pro forma basis or on a pro forma as adjusted basis |
1,458 | — | ||||||||
| Common stock, par value $0.0001 per share, 555,333 shares authorized; 20,230 shares issued and outstanding, actual; 555,333 shares authorized, 403,266 shares issued and outstanding on a pro forma basis; shares authorized, shares issued and outstanding on a pro forma, as adjusted basis(1) |
— | — | ||||||||
| Additional paid-in capital(1) |
16,103 | 73,011 | ||||||||
| Accumulated other comprehensive income |
1,741 | 1,741 | ||||||||
| Accumulated deficit |
(61,593 | ) | (69,900 | ) | ||||||
| Total stockholders’ (deficit) equity(1) |
(42,291 | ) | 4,852 | |||||||
| Total capitalization(1) |
$ | (6,378 | ) | $ | 12,194 | |||||
| (1) | A $1.00 increase (decrease) in the assumed initial public offering price of $ would increase (decrease) each of cash and cash equivalents, common stock, additional paid-in capital, total stockholders’ equity and total capitalization by $ million, assuming the number of shares offered by us, as set forth on the cover of this prospectus, remains the same after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. |
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| (2) | The information above does not give effect to a financing transaction consummated in January and February 2007, in which we issued an aggregate of 9,776,162 shares of our Series C-1, Series C-2 and Series C-3 convertible preferred stock at a price of $10.45 per share, in consideration of (i) gross proceeds of approximately $58.4 million (including the reinvestment of repaid convertible notes, in the amount of approximately $2.4 million, including principal and accrued interest), (ii) the conversion of previously issued convertible promissory notes in the aggregate amount of $24.6 million, including principal and accrued interest, and (iii) the conversion of $17.5 million in convertible notes payable to InterMune. We issued 8,350,539 of those shares at an initial closing on January 31, 2007 and 708,028 shares at a second closing on February 16, 2007. We issued the remaining 717,595 shares on February 7, 2007 in accordance with the achievement of the first InterMune milestone. We also issued warrants exercisable for an aggregate (on an as-exchanged basis) of 484,354 shares of Series C-1 preferred stock and 29,855 shares of common stock in connection with these share issuances. Giving effect to this transaction, as of December 31, 2006 and assuming gross proceeds of $58.4 million, we would have had cash, cash equivalents and short-term investments of $70.9 million and debt balances of $7.3 million. |
The number of shares of our common stock outstanding following this offering is based on 11,457,760 shares of our common stock outstanding as of April 30, 2007, and excludes:
| • | 2,051,749 shares of our common stock reserved for issuance under our stock plan, of which options to purchase 46,017 shares of our common stock are outstanding at a weighted average price of $50.94 per share; |
| • | the issuance of up to 603,370 shares of our common stock upon the exercise of outstanding warrants at a weighted average price of $13.86 per share, all of which are currently exercisable; and |
| • | shares potentially issuable to InterMune upon our future achievement of a milestone under our agreements with InterMune, consisting of 358,798 shares of our Series C-2 preferred stock and 358,797 shares of our Series C-3 preferred stock, as well as a warrant exercisable for up to 35,553 shares of our Series C-1 preferred stock. |
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DILUTION
As of December 31, 2006, we had a historical net tangible book value (deficit) of $(42.3) million, or approximately $(2,090.50) per share of common stock. Historical net tangible book value per share represents the amount of our total tangible assets less our total liabilities and redeemable convertible preferred stock, divided by the number of shares of common stock outstanding. Pro forma net tangible book value per share represents the amount of our total tangible assets less our total liabilities, divided by the total number of shares of common stock outstanding, as of December 31, 2006, after giving effect to the conversion of all of our series A convertible preferred stock, series B redeemable convertible preferred stock and convertible debt into shares of our common stock upon the closing of this offering.
After giving effect to this offering and the receipt of $ million of net proceeds from this offering, based on an assumed initial public offering price of $ per share, the midpoint of the price range set forth on the front cover of this prospectus, the pro forma net tangible book value of our common stock as of December 31, 2006, would have been $ million, or $ per share. This amount represents an immediate increase in net tangible book value of $ per share to the existing stockholders and an immediate dilution in net tangible book value of $ per share to purchasers of our common stock in this offering. Dilution is determined by subtracting pro forma net tangible book value per share after this offering from the amount of cash paid by a new investor for a share of common stock. The new investors will have paid $ per share even though the per share value of our assets after subtracting our liabilities is only $ . In addition, the total consideration from new investors will be $ million, which is % of the total of $ million paid for all shares of common stock outstanding, but new investors will own only % of our outstanding shares of common stock. The following table illustrates such dilution:
| Assumed initial public offering price per share |
$ | ||||||
| Historical net tangible book value per share as of December 31, 2006 |
$ | (2,090.50 | ) | ||||
| Increase per share attributable to conversion of convertible preferred stock and convertible debt |
2,102.53 | ||||||
| Pro forma net tangible book value per share at December 31, 2006 |
$ | 12.03 | |||||
| Increase per share attributable to new investors |
|||||||
| Pro forma as adjusted net tangible book value per share after offering |
|||||||
| Dilution of net tangible book value per share to new investors in this offering |
$ | ||||||
Each $1.00 increase (decrease) in the public offering price per share would increase (decrease) the pro forma net tangible book value by $ per share (assuming no exercise of the underwriters’ option to purchase additional shares) and the dilution to investors in this offering by $ per share, assuming that the number of shares offered in this offering as set forth on the front cover of this prospectus remains the same.
If the underwriters exercise their over allotment option in full, the pro forma net tangible book value per share after the offering would have been $ million, or $ per share. This amount represents an immediate increase in net tangible book value of $ per share to the existing stockholders and an immediate dilution in net tangible book value of $ per share to purchasers of our common stock in this offering.
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The following table sets forth, as of December 31, 2006, on the pro forma basis described above, the number of shares of common stock purchased from us, the total consideration paid to us and the average price per share paid by existing stockholders and by new investors who purchase shares of our common stock in this offering, before deducting the underwriting discounts and commissions and estimated offering expenses.
| Shares Purchased | Total Consideration | Average Per Share | ||||||||||||
| Number | Percent | Amount | Percent | |||||||||||
| (In thousands, except share and per share data) | ||||||||||||||
| Existing stockholders |
403,266 | % | $ | 40,513 | % | $ | 100.46 | |||||||
| New investors |
% | % | ||||||||||||
| Total |
100 | % | $ | 100 | % | |||||||||
Both of the tables above reflect the conversion of 15,643 shares of our series A convertible preferred stock and 140,744 shares of our series B redeemable convertible preferred stock, which includes 25,575 shares which represent the accumulated dividend associated with the series B redeemable convertible preferred stock and 226,649 shares from the conversion of our convertible debt into an aggregate of 383,036 shares of common stock upon the closing of this offering and assumes no exercise of the underwriter’s allotment option and no exercise of stock options or warrants after December 31, 2006. As of December 31, 2006, we had outstanding options to purchase a total of 46,017 shares of common stock at a weighted average exercise price of $50.94 per share and outstanding warrants to purchase a total of 6,837 shares of our series B redeemable convertible preferred stock at a weighted average exercise price of CAN$234.00 or US $200.81 per share as of December 31, 2006. To the extent that outstanding options or warrants are exercised in the future, there will be further dilution to new investors.
40
SELECTED CONSOLIDATED FINANCIAL DATA
This section presents our historical financial data. You should read the selected financial data below in conjunction with “Management’s discussion and analysis of financial condition and results of operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. The selected financial data in this section are not intended to replace the consolidated financial statements. We have derived the statement of operations data for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006 and the period from May 20, 1997 (date of inception) through December 31, 2006 and the balance sheet data as of December 31, 2005 and 2006 from our consolidated financial statements included elsewhere in this prospectus, which have been audited by Ernst & Young LLP, independent registered public accounting firm. We have derived the consolidated statements of operations data for the years ended May 31, 2002 and 2003 and the consolidated balance sheet data as of May 31, 2002, 2003, 2004 and 2005 from a reconciliation to U.S. GAAP of audited Canadian GAAP financial statements, which have not been audited for U.S. GAAP purposes. These financial statements are not included herein. In the opinion of management, the unaudited consolidated financial statements have been prepared on the same basis as the audited consolidated statements and contain all adjustments necessary for the fair presentation of our results of operations for these periods and financial position as of such dates. See the notes to the consolidated financial statements for an explanation of the method used to determine the number of shares used in determining basic and diluted and pro forma basic and diluted net loss per common share. Pro forma basic and diluted net loss per common share have been calculated assuming the conversion of all outstanding shares of convertible preferred stock, redeemable convertible preferred stock and convertible debt at the beginning of the period (or at the original date of issuance, if later) into common stock. In 2005, we changed our fiscal year end from May 31 to December 31.
| Year Ended 2002 |
Year Ended 2003 |
Year Ended 2004 |
Year Ended 2005 |
Seven Months 2005 |
Year Ended 2006 |
For the Period 2006 |
||||||||||||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||||||||||||||
| Statement of operations data: |
||||||||||||||||||||||||||||
| Operating expenses |
||||||||||||||||||||||||||||
| Research and development |
$ | 1,508 | $ | 2,556 | $ | 5,198 | $ | 4,503 | $ | 2,319 | $ | 11,456 | $ | 30,747 | ||||||||||||||
| Acquired in-process research and development |
— | — | — | — | 11,847 | — | 11,847 | |||||||||||||||||||||
| General and administrative |
626 | 1,174 | 1,506 | 1,388 | 2,114 | 3,678 | 11,461 | |||||||||||||||||||||
| Total operating expenses |
2,134 | 3,730 | 6,704 | 5,891 | 16,280 | 15,134 | 54,055 | |||||||||||||||||||||
| Other income (expense) |
||||||||||||||||||||||||||||
| Interest income |
54 | 139 | 125 | 78 | 31 | 280 | 915 | |||||||||||||||||||||
| Interest expense |
(26 | ) | (46 | ) | (41 | ) | (211 | ) | (846 | ) | (14,642 | ) | (15,893 | ) | ||||||||||||||
| Foreign exchange gain (loss) |
— | — | — | — | 15 | (214 | ) | (199 | ) | |||||||||||||||||||
| Gain on disposal of property and equipment |
— | 12 | — | — | — | — | 47 | |||||||||||||||||||||
| Other income (expense), net |
28 | 105 | 84 | (133 | ) | (800 | ) | (14,576 | ) | (15,130 | ) | |||||||||||||||||
| Loss before income tax benefit |
(2,106 | ) | (3,625 | ) | (6,620 | ) | (6,024 | ) | (17,080 | ) | (29,710 | ) | (69,185 | ) | ||||||||||||||
| Income tax benefit |
696 | 935 | 1,517 | 1,364 | 1,015 | 384 | 7,592 | |||||||||||||||||||||
| Net loss |
$ | (1,410 | ) | $ | (2,690 | ) | $ | (5,103 | ) | $ | (4,660 | ) | $ | (16,065 | ) | $ | (29,326 | ) | $ | (61,593 | ) | |||||||
| Net loss per share—basic and diluted |
$ | (82.88 | ) | $ | (185.90 | ) | $ | (344.16 | ) | $ | (305.33 | ) | $ | (828.72 | ) | $ | (1,596.18 | ) | ||||||||||
| Weighted average number of common shares used in net loss per share—basic and diluted |
18,908 | 19,469 | 20,209 | 20,216 | 20,230 | 20,230 | ||||||||||||||||||||||
| Unaudited |
||||||||||||||||||||||||||||
| Pro forma net loss per share—basic and diluted |
$ | (120.13 | ) | |||||||||||||||||||||||||
| Shares used in computing pro forma net loss per share—basic and diluted |
298,918 | |||||||||||||||||||||||||||
41
| 2002 |
2003 |
2004 |
2005 |
2005 |
2006 |
|||||||||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||
| Balance sheet data: |
||||||||||||||||||||||||
| Cash, cash equivalents and short-term investments |
$ | 4,656 | $ | 7,732 | $ | 1,767 | $ | 2,572 | $ | 12,209 | $ | 12,533 | ||||||||||||
| Working capital |
4,802 | 8,238 | 2,986 | 3,422 | 10,263 | (7,683 | ) | |||||||||||||||||
| Total assets |
6,619 | 10,325 | 5,342 | 5,299 | 16,169 | 15,214 | ||||||||||||||||||
| Note payable |
— | — | (59 | ) | 3,833 | 6,529 | 7,297 | |||||||||||||||||
| Convertible debt |
— | — | — | — | 9,702 | 28,516 | ||||||||||||||||||
| Long-term portion of capital lease obligations |
355 | 430 | 183 | 15 | — | — | ||||||||||||||||||
| Series B redeemable convertible preferred stock |
5,064 | 11,259 | 13,110 | 14,623 | 15,023 | 17,988 | ||||||||||||||||||
| Deficit accumulated during the development stage |
(3,749 | ) | (6,439 | ) | (11,542 | ) | (16,202 | ) | (32,267 | ) | (61,593 | ) | ||||||||||||
| Total stockholders’ (deficit) equity |
407 | (2,190 | ) | (8,708 | ) | (14,169 | ) | (19,458 | ) | (42,291 | ) | |||||||||||||
The information above does not give effect to a financing transaction consummated in January and February 2007, in which we issued an aggregate of 9,776,162 shares of our Series C-1, Series C-2 and Series C-3 convertible preferred stock at a price of $10.45 per share, in consideration of (i) gross proceeds of approximately $58.4 million, (ii) the conversion of previously issued convertible promissory notes in the aggregate amount of $24.6 million, including principal and accrued interest, and (iii) the conversion of $17.5 million in convertible notes payable to InterMune. We issued 8,350,539 of those shares at an initial closing on January 31, 2007 and 708,028 shares at a second closing on February 16, 2007. We issued the remaining 717,595 shares on February 7, 2007 in accordance with the achievement of the first InterMune milestone. We also issued warrants exercisable for an aggregate (on an as-exchanged basis) of 484,354 shares of Series C-1 preferred stock and 29,855 shares of common stock in connection with these share issuances. Giving effect to this transaction, as of December 31, 2006 and assuming gross proceeds of $58.4 million, we would have had cash, cash equivalents and short-term investments of $70.9 million and debt balances of $7.3 million.
42
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and their notes appearing elsewhere in this prospectus. The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those discussed below and elsewhere in this prospectus, particularly under the heading “Risk Factors.”
Overview
We are a biopharmaceutical company focused on the development and commercialization of innovative antibiotics for serious infections treated or acquired in hospitals and other institutional settings. We are developing oritavancin, a novel intravenous antibiotic, for the treatment of serious gram-positive bacterial infections including cSSSI and bacteremia. We expect to submit an NDA for oritavancin for the treatment of cSSSI in the first quarter of 2008 and hope to receive regulatory approvals in late 2008 in the United States and thereafter in Europe. We plan on commercializing oritavancin through our own direct sales force in the United States and in select other countries, and to out-license oritavancin to third parties in other countries as we deem appropriate. In addition, we have discovered another antibiotic that is currently in pre-clinical development for osteomyelitis, and we continually evaluate opportunities for potential in-licensing of other antibiotics for the treatment of hospital-based infections.
We acquired worldwide rights to oritavancin from InterMune in December 2005, and believe that since then we have greatly improved the commercial and economic prospects for the drug by resolving several important issues with the FDA and by substantially lowering the royalty rate that may be payable to Lilly, the original discoverer of oritavancin. Our strategy is to capitalize on the unique attributes of oritavancin to develop it into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for cSSSI and subsequently for other indications.
We are incorporated as a Delaware corporation, effective December 6, 2005, with two subsidiaries in Canada, and we initiated operations through our Canadian subsidiary in May 1997 in Montreal, Quebec. To date, we have dedicated substantially all of our activities to the research and development of our drug candidates. Accordingly, we are considered to be in the development stage at December 31, 2006, as defined in Statement of Financial Accounting Standards (“SFAS”) No. 7, “Accounting and Reporting by Development Stage Enterprises.” Our fiscal year ends on December 31 and we operate as one reportable segment. In 2005, we changed our fiscal year end from May 31 to December 31. Prior to our acquisition of oritavancin in December 2005, we were focused on early-stage research in the area of antibiotics and the application of our phage technology.
We have not generated any revenue to date from product sales and have incurred significant operating losses since our inception in 1997. We incurred net losses of $2.7 million, $5.1 million and $4.7 million in fiscal years ended May 31, 2003, 2004 and 2005, respectively, and $16.1 million for the seven months ended December 31, 2005 and $29.3 million for the fiscal year ended December 31, 2006. As of December 31, 2006, we had an accumulated deficit of $61.6 million and we expect to incur losses for the foreseeable future.
We expect to incur substantial expenditures in the foreseeable future for the continued development of our product candidates and, if we obtain regulatory approval, for the commercialization of those products. We expect to continue to incur operating losses for at least the next several years, and we will need additional financing to support our activities. We will seek to fund our operations through public or private equity or debt financings or other sources, such as collaborations. Adequate additional funding may not be available to us on acceptable
43
terms, or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If adequate funds are not available to us, we may be required to delay, reduce or eliminate research and development programs, reduce or eliminate commercialization efforts, obtain funds through arrangements with collaborators or others on terms unfavorable to us or pursue merger or acquisition strategies.
Financial Obligations Related to License of Oritavancin
Lilly License Agreement
In December 2005, in connection with our acquisition from InterMune of assets related to oritavancin, we became a party to a license agreement with Lilly pursuant to which we acquired worldwide license rights to patents and other intellectual property related to oritavancin. Pursuant to the license agreement, we are obligated to make the following milestone payments to Lilly:
| Milestone |
Required Payment | ||
| First regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections |
$ | 10,000,000 | |
| Second regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections |
$ | 10,000,000 | |
| First calendar year in which net sales exceed $210,000,000 |
$ | 15,000,000 | |
In addition, pursuant to the license agreement, we are obligated to pay Lilly certain royalties based on our net sales of oritavancin drug product in any calendar year in any jurisdiction in which, under the license agreement, we hold license rights to a valid patent. These royalty obligations are calculated on an aggregate, tiered basis with the royalty percentage increasing based on our realization of qualifying net sales in any calendar year above established thresholds.
Under the license agreement with Lilly, our license rights continue on a country-by-country basis until there are no further royalty obligations in a specific country, at which time we will have a fully paid-up, perpetual, irrevocable, exclusive, sublicenseable license to make, have made, use, offer to sell, sell and import oritavancin in fields relating to infectious diseases in the applicable country.
InterMune Agreement
In connection with our acquisition of the worldwide rights to oritavancin from InterMune in December 2005, we entered into an asset purchase agreement with InterMune pursuant to which we agreed to pay InterMune a total of up to $25 million in convertible debt and $9 million in cash, such payments to be in the form of both initial payments and future milestone payments. In addition, we agreed to pay Lilly $1 million in cash, which payment was made in January 2006. As of April 15, 2007, due to the consummation of our acquisition of the worldwide rights to oritavancin and our achievement of an initial milestone, we had made payments to InterMune that totaled $17.5 million in convertible debt (all of which has converted into shares of our capital stock) and a total of $4 million in cash. All cash payments to Lilly and InterMune have been recorded as acquired in-process research and development expenses in the consolidated financials statements.
Pursuant to the asset purchase agreement, as amended to date, and the related convertible promissory note we issued to InterMune, as also amended to date, we will issue InterMune additional convertible debt worth $7.5 million, which debt will immediately and automatically convert into shares of our capital stock, upon the earlier to occur of (a) our receipt of authorization from the FDA (whether verbal or written) to conduct, or our first dosing of a subject in, a clinical study of oritavancin in the United States, which clinical study is designed to assess the efficacy of oritavancin (excluding for this purpose any clinical study for cSSSI with a single daily intravenous dose of 200 mg/day of oritavancin (or 300 mg/day for patients weighing greater than 110 kg)); or
44
(b) the consummation of our initial public offering. In addition, we are obligated to make a further $5 million cash payment to InterMune if and when we receive from the FDA all approvals necessary for the commercial launch of oritavancin. We have no other milestone or royalty obligations to InterMune in connection with our December 2005 acquisition of the worldwide rights to oritavancin.
Financial Overview
Revenue. We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products unless we receive regulatory approval for commercial sale of oritavancin. We also may seek to generate revenue from collaborative partners through a combination of up-front license fees, milestone payments, and royalties. Since our inception, we have not entered into any revenue-generating collaboration arrangements.
Research and development expense. Research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. These expenses consist primarily of salaries and related expenses, allocated facility costs and third-party contract costs relating to research, formulation, manufacturing, preclinical study and clinical trial activities. We charge all research and development expenses to operations as incurred. We expect our research and development costs to be substantial and to increase as we conduct further clinical trials on oritavancin for additional indications and advance other product candidates into preclinical studies and clinical trials.
Assuming we receive regulatory approval for oritavancin for the treatment of cSSSI, after the initial launch of oritavancin, we expect to continue to incur significant research and development costs as we perform additional clinical trials in order to apply for regulatory approval for additional indications, as well as to advance our additional product candidates. We cannot predict the timing or total cost of completion of these efforts as they are dependent on our discussions with regulatory agencies on clinical trial design and our ability to achieve clinical objectives, which is inherently uncertain. As a result of these uncertainties, we are unable to determine the duration and completion costs of these development activities or whether, when and to what extent we may generate revenues based upon additional indications for oritavancin. Our inability to complete our research and development projects in a timely manner could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could require us to seek additional, external sources of financing from time to time in order to continue to pursue our strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
Acquired in-process research and development expense. Acquired in-process research and development expense primarily consists of payments due to InterMune and Lilly for a total of $3.0 million related to our agreement with InterMune and the discounted value of the convertible note issued to InterMune of approximately $8.8 million. We expect to incur additional acquired in-process research and development expense as we meet additional milestones under our agreement with InterMune and are required to make additional payments to InterMune.
General and administrative expenses. General and administrative expense consists primarily of salaries and related expenses for personnel in our administrative, finance, business development and human resource functions. Other costs include legal costs of pursuing patent protection of our intellectual property, allocated facility costs and professional fees for accounting and legal services. After this offering, we anticipate increases in general and administrative expense relating to the additional expense of operating as a public company. These increases will likely include legal fees, accounting fees and directors’ and officers’ insurance premiums, as well as fees for investor relations services.
Interest expense. Interest expense consists primarily of interest, amortization of beneficial conversion features and debt discount, and amortization of deferred financing costs associated with our note payable and convertible debt issued in December 2005 and convertible debentures issued in 2006. In the seven months ended December 31, 2005 and the year ended December 31, 2006, approximately $529,000 and $12.5 million,
45
respectively, of interest expense was related to the amortization of the beneficial conversion features and debt discount associated with the convertible debt. We expect interest expense to decrease in future periods as our convertible debt converts into common stock and the remaining unamortized debt discount and beneficial conversion features will be charged to interest expense upon the closing of the Series C financing transaction.
Results of Operations
Year ended December 31, 2006 compared to year ended May 31, 2005
Revenue. We recorded no revenue in the fiscal years ended May 31, 2005 or December 31, 2006.
Research and development expense. Research and development expense during the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:
| Year ended | Change | |||||||||||
| May 31, 2005 |
December 31, 2006 |
$ | % | |||||||||
| ($ in thousands) | ||||||||||||
| Research and development |
$ | 4,503 | $ | 11,456 | $ | 6,953 | 154.4 | % | ||||
Research and development expense for the fiscal year ended December 31, 2006 was $11.5 million, compared to $4.5 million for the fiscal year ended May 31, 2005. Due to our acquisition of oritavancin in December 2005, we incurred several expenses in 2006 that we did not incur prior to that acquisition, including $2.5 million for research contracts expense, comprised of $1.4 million in amounts paid to manage our clinical database work done in preparation for the NDA submission for oritavancin, $900,000 in amounts paid for third party product manufacturing and validation work in preparation for the commercial launch of oritavancin, and $216,000 in amounts paid for third party pre-clinical work for the osteomyelitis program. Further, the increase during fiscal 2006 in research and development expense was attributable to: an increase of $2.0 million in salaries and benefits expenses, which increased from $2.2 million to $4.2 million mainly due to the hiring of 28 development employees related to the oritavancin program and partially offset by a decrease of 9 research employees; an increase of $1.3 million in consultant costs, which increased from $154,000 to $1.5 million, primarily related to preparation for the oritavancin NDA submission; an increase of $445,000 in laboratory supply costs, comprised of non-capital consumable and durable goods used in research activities (e.g. reagents, laboratory glassware, chemicals and solutions), which increased from $911,000 to $1.4 million, mainly due to increased costs for testing of oritavancin, partially offset by a decrease in laboratory supply expense resulting from a decrease in the number of full-time laboratory staff.
General and administrative expense. General and administrative expense during the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:
| Year ended | Change | |||||||||||
| May 31, 2005 |
December 31, 2006 |
$ | % | |||||||||
| ($ in thousands) | ||||||||||||
| General and administrative |
$ | 1,388 | $ | 3,678 | $ | 2,290 | 165.0 | % | ||||
General and administrative expense for the fiscal year ended December 31, 2006 was $3.7 million, compared to $1.4 million for the fiscal year ended May 31, 2005. The increase in general and administrative expense in fiscal 2006 was primarily the result of a $943,000 increase in amounts paid for legal, accounting and consulting fees, which increased from $187,000 to $1.1 million; an increase of $286,000 in amounts paid for recruiting fees, which increased from $76,000 to $362,000, due to the recruitment of our Chief Executive Officer and Chief Financial Officer and the initiation of our search for a Chief Commercial Officer; an increase of $226,000 in amounts paid for salary and benefit expenses associated with the hiring of additional administrative
46
staff (including our Chief Executive Officer and our Chief Financial Officer), which increased from $539,000 to $765,000; and an increase of $195,000 in amounts paid for marketing expenses, which increased from $95,000 to $290,000 primarily due to market research related to oritavancin.
Interest income. Interest income for the years ended May 31, 2005 and December 31, 2006 was as follows:
| Year ended | Change | |||||||||||
| May 31, 2005 |
December 31, 2006 |
$ | % | |||||||||
| ($ in thousands) | ||||||||||||
| Interest income |
$ | 78 | $ | 280 | $ | 202 | 259.0 | % | ||||
Interest income for the fiscal year ended December 31, 2006 was $280,000, compared to $78,000 for the fiscal year ended May 31, 2005. The increase in interest income from 2005 to 2006 was due primarily to higher average cash and cash equivalent balances during 2006, due to the receipt of approximately $11.8 million of net proceeds from our October and December 2005 convertible note financings, as well as a slight increase in interest rates.
Interest expense. Interest expense for the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:
| Year ended | Change | |||||||||||||
| May 31, 2005 |
December 31, 2006 |
$ | % | |||||||||||
| ($ in thousands) | ||||||||||||||
| Interest expense |
$ | (211 | ) | $ | (14,642 | ) | $ | (14,431 | ) | N.M. | ||||
Interest expense for the fiscal year ended December 31, 2006 was $14.6 million, compared to $211,000 for the fiscal year ended May 31, 2005. The increase in interest expense from 2005 to 2006 was primarily due to an increase of $12.5 million in debt discount amortization associated with the issuance of warrants and the beneficial conversion feature associated with the convertible notes, $1.0 million of interest expense in connection with the convertible notes issued in October and December 2005, including the convertible note issued to InterMune in December 2005, as well as an increase of $898,000 of interest expense on the Investissement Québec (or IQ) loan due to an increase in the note payable balance and an increase in the fair value of the warrants issued to IQ.
Income tax benefit. Income tax benefit represents a refundable tax credit provided by the Canadian and Ontario and Quebec provincial governments, calculated based on the amount of research and development expenses deemed to be allowable under applicable Canadian tax law. Allowable expenses are primarily expense items like salary and benefits for research and development staff. Income tax benefit for the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:
| Year ended | Change | ||||||||||||
| May 31, 2005 |
December 31, 2006 |
$ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Income tax benefit |
$ | 1,364 | $ | 384 | $ | (980 | ) | (71.8 | )% | ||||
Income tax benefit for the year ended December 31, 2006 was $384,000, compared to $1.4 million for the year ended May 31, 2005. The decrease from 2005 to 2006 was due to the loss of a Canadian tax benefit when we restructured and became a US controlled entity.
47
Year ended May 31, 2005 compared to year ended May 31, 2004
Revenue. We recorded no revenue in the fiscal years ended May 31, 2004 or 2005.
Research and development expense. Research and development expense during the fiscal years ended May 31, 2004 and 2005 was as follows:
| Year ended May 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Research and development |
$ | 5,198 | $ | 4,503 | $ | (695 | ) | (13.4 | )% | ||||
Research and development expense for the fiscal year ended May 31, 2005 was $4.5 million, compared to $5.2 million for the fiscal year ended May 31, 2004. The decrease during fiscal 2005 in research and development expense was primarily the result of a $710,000 decrease in laboratory supply costs, which decreased from $1.6 million to $911,000, primarily as a result of an expenditure of $650,000 in 2004 for a chemistry compound library; a decrease of $104,000 in research contract expense, which decreased from $105,000 to $1,000 due to a phage research program expense of $104,000 in 2004; a decrease of $45,000 in salaries and benefits expenses, which decreased from $2.3 million to $2.2 million; partially offset by a $146,000 increase in rent expense, which increased from $281,000 to $427,000 due to the expansion of our chemistry and in vivo laboratory space.
General and administrative expense. General and administrative expenses during the fiscal years ended May 31, 2004 and 2005 was as follows:
| Year ended May 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| General and administrative |
$ | 1,506 | $ | 1,388 | $ | (118 | ) | (7.8 | )% | ||||
General and administrative expense for the year ended May 31, 2005 was $1.4 million, compared to $1.5 million for the year ended May 31, 2004. The decrease during fiscal 2005 in general and administrative expense was primarily the result of a $141,000 decrease in salary and benefit expenses, which decreased from $680,000 to $539,000 primarily related to the elimination of the Director of Business Development position; and a $120,000 decrease in professional services fees, which decreased from $307,000 to $187,000 due primarily to fees incurred in 2004 related to capital restructuring consultants and legal fees related to potential financing; partially offset by a $52,000 increase in marketing expenses, which increased from $43,000 to $95,000 as a result of a commissioned research study on the osteomyelitis market.
Interest income. Interest income for the fiscal years ended May 31, 2004 and 2005 was as follows:
| Year ended May 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Interest income |
$ | 125 | $ | 78 | $ | (47 | ) | (37.6 | )% | ||||
Interest income for the fiscal year ended May 31, 2005 was $78,000, compared to $125,000 for the fiscal year ended May 31, 2004. The decrease in interest income during fiscal 2005 was due to lower average cash and cash equivalent balances during 2005.
48
Interest expense. Interest expense for the fiscal years ended May 31, 2004 and 2005 was as follows:
| Year ended May 31, | Change | ||||||||||||||
| 2004 | 2005 | $ | % | ||||||||||||
| ($ in thousands) | |||||||||||||||
| Interest expense |
$ | (41 | ) | $ | (211 | ) | $ | (170 | ) | 414.6 | % | ||||
Interest expense for the year ended May 31, 2005 was $211,000, compared to $41,000 for the year ended May 31, 2004. The increase in interest expense in fiscal 2005 was primarily due to an increase of $151,000 in interest related to the IQ loan and an increase of $35,000 in amortization of deferred financing costs related to this loan.
Income tax benefit. Income tax benefit for the fiscal years ended May 31, 2004 and 2005 was as follows:
| Year ended May 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Income tax benefit |
$ | 1,517 | $ | 1,364 | $ | (153 | ) | (10.1 | )% | ||||
Income tax benefit for the fiscal year ended May 31, 2005 was $1.4 million, compared to $1.5 million for the fiscal year ended May 31, 2004. The decrease in fiscal 2005 was due to decreased research and development expense in 2005 compared to 2004.
Seven months ended December 31, 2005 compared to seven months ended December 31, 2004 (unaudited)
Revenue. We recorded no revenue during the seven months ended December 31, 2004 or 2005.
Research and development expense. Research and development expense during the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Research and development |
$ | 2,682 | $ | 2,319 | $ | (363 | ) | (13.5 | )% | ||||
Research and development expense for the seven months ended December 31, 2005 was $2.3 million, compared to $2.7 million for the seven months ended December 31, 2004. The decrease during the seven months ended December 31, 2005 in research and development expense was primarily the result of a $303,000 decrease in laboratory supply costs, which decreased from $596,000 to $293,000 primarily as a result of an expenditure in 2004 for a chemistry compound library; a $244,000 decrease in salaries and benefits expenses, which decreased from $1.3 million to $1.1 million primarily due to a decrease of 9 research employees; partially offset by a $113,000 increase in rent expense, which increased from $196,000 to $309,000 due to the expansion of our chemistry and in vivo laboratory space.
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Acquired in-process research and development expenses. Acquired in-process research and development expense during the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31 | Change | ||||||||||
| 2004 | 2005 | $ | % | ||||||||
| ($ in thousands) | |||||||||||
| Acquired in-process research and development |
— | $ | 11,847 | $ | 11,847 | 100 | % | ||||
Acquired in-process research and development expense for the seven months ended December 31, 2005 increased $11.8 million as a result of the acquisition of the oritavancin asset. For the seven months ended December 31, 2004 our acquired in-process research and development expense was zero.
General and administrative expense. General and administrative expense during the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31, | Change | |||||||||||
| 2004 | 2005 | $ | % | |||||||||
| ($ in thousands) | ||||||||||||
| General and administrative |
$ | 737 | $ | 2,114 | $ | 1,377 | 186.8 | % | ||||
General and administrative expense for the seven months ended December 31, 2005 was $2.1 million, a $1.4 million increase as compared to $737,000 for the seven months ended December 31, 2004. The increase during the seven months ended December 31, 2005 in general and administrative expense was primarily the result of a $1.2 million increase in professional services fees, which increased from $138,000 to $1.4 million due primarily to fees incurred from diligence and closing activities related to the acquisition of the oritavancin asset, as well as the expense of sustaining the oritavancin patent portfolio; a $57,000 increase in salary and benefit expenses, which increased from $334,000 to $391,000 primarily related to merit pay increases; and a $53,000 increase in marketing expenses, which increased from $1,000 to $54,000 as a result of a commissioned research study on the osteomyelitis market.
Interest income. Interest income for the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31, | Change | ||||||||||||
| 2004 | 2005 | $ | % | ||||||||||
| ($ in thousands) | |||||||||||||
| Interest income |
$ | 50 | $ | 31 | $ | (19 | ) | (38.0 | )% | ||||
Interest income for the seven months ended December 31, 2005 was $31,000, compared to $50,000 for the seven months ended December 31, 2004. The decrease in interest income for the seven months ended December 31, 2005 was due to lower average cash and cash equivalent balances during the seven months ended 2005.
Interest expense. Interest expense for the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31, | Change | ||||||||||||||
| 2004 | 2005 | $ | % | ||||||||||||
| ($ in thousands) | |||||||||||||||
| Interest expense |
$ | (72 | ) | $ | (846 | ) | $ | (774 | ) | 1075.0 | % | ||||
Interest expense for the seven months ended December 31, 2005 was $846,000, compared to $72,000 for the seven months ended December 31, 2004. The increase in interest expense for the seven months ended December 31, 2005 was primarily due to an increase of $569,000 in interest expense in connection with convertible notes issued in October and December 2005, including the convertible notes in the amount of
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$13.0 million issued to InterMune in December 2005, and an increase of $212,000 in interest related to the IQ loan, partially offset by a $12,000 decrease in capital lease expense.
Income tax benefit. Income tax benefit for the seven months ended December 31, 2004 and 2005 was as follows:
| Seven months ended December 31, | Change | |||||||||||
| 2004 | 2005 | $ | % | |||||||||
| ($ in thousands) | ||||||||||||
| Income tax benefit |
$ | 817 | $ | 1,015 | $ | 198 | 24.2 | % | ||||
Income tax benefit for the seven months ended December 31, 2005 was $1.0 million, compared to $817,000 for the seven months ended December 31, 2004. The increase in income tax recovery for the seven months ended December 31, 2005 resulted from an assessment provided by the Canadian government that was performed during the seven months ended December 31, 2005 that resulted in additional income tax recovery credits from prior periods being recorded in 2005. Acquired in-process research did not affect the income tax benefit amount as it was not considered to be a Canadian expense.
Liquidity and Capital Resources
We have incurred losses since our inception in May 20, 1997 and, as of December 31, 2006, we had an accumulated deficit of $61.6 million. We have financed our operations to date primarily through the sale of preferred stock and common stock, debt financings, interest earned on investments and investment tax credits. Through December 31, 2006, we have received aggregate gross proceeds of $47.4 million from financings, of which $12.0 million was from the issuance of preferred stock, $2.7 million was from the issuance of common stock and $32.7 million was from debt financings. Our cash and cash equivalents include amounts held in money market funds and an overnight investment account, stated at cost plus accrued interest, which approximates fair market value. We invest cash in excess of immediate requirements in accordance with our investment policy, primarily to achieve liquidity and capital preservation.
In January and February 2007, we issued an aggregate of 9,776,162 shares of our Series C-1, Series C-2 and Series C-3 convertible preferred stock at a price of $10.45 per share, in consideration of (i) gross proceeds of approximately $58.4 million, (ii) the conversion of previously issued convertible promissory notes in the aggregate amount of $24.6 million, including principal and accrued interest, and (iii) the conversion of $17.5 million of convertible notes payable to InterMune. We issued 8,350,539 of those shares at an initial closing on January 31, 2007 and 708,028 shares at a second closing on February 16, 2007. We issued the remaining 717,595 shares on February 7, 2007 in accordance with the achievement of the first InterMune milestone. We also issued warrants exercisable in the aggregate (on an as-exchanged basis) for 484,354 shares of Series C-1 Preferred Stock and 29,855 shares of common stock in connection with these share issuances. After giving effect to this financing, as of December 31, 2006, on a pro forma basis, our cash, cash equivalents and short-term investments and our long-term debt would have been $70.9 million and $7.3 million, respectively.
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The following table summarizes our net (decrease) increase in cash and cash equivalents for the fiscal years ended May 31, 2004 and 2005, the seven months ended December 31, 2005 and the fiscal year ended December 31, 2006:
| Year ended May 31, | Seven months ended 2005 |
Year ended 2006 |
||||||||||||||
| 2004 | 2005 | |||||||||||||||
| ($ in thousands) | ||||||||||||||||
| Net cash provided by (used in): |
||||||||||||||||
| Operating activities |
$ | (5,119 | ) | $ | (3,030 | ) | $ | (3,747 | ) | $ | (13,299 | ) | ||||
| Investing activities |
5,284 | (128 | ) | (7 | ) | (182 | ) | |||||||||
| Financing activities |
(377 | ) | 3,799 | 13,183 | 13,525 | |||||||||||
| Net increase (decrease) in cash and cash equivalents |
$ | (212 | ) | $ | 641 | $ | 9,429 | $ | 44 | |||||||
Net cash used in operating activities. Net cash used in operating activities was $3.0 million for the fiscal year ended May 31, 2005, compared to $13.3 million for the fiscal year ended December 31, 2006. This $10.3 million increase in cash used in operations was due primarily to:
| • | an increase in net loss of $24.7 million which was a result of the increase in research and development and general and administrative expenditures as described above; |
| • | a partial offset related to an increase in non-cash interest expense of $14.5 million; |
| • | a partial offset related to an increase in the non-cash amortization of deferred financing costs of $326,000; and |
| • | an increase in the net changes in working capital items relating to operations of $389,000. |
Net cash used in operating activities was $5.1 million for the fiscal year ended May 31, 2004, compared to $3.0 million for the fiscal year ended May 31, 2005. The $2.1 million decrease from 2005 compared with 2004 in cash used in operations was due primarily to a decrease in the amount needed to fund working capital needs of $1.3 million; a decrease in the net loss of $443,000; an increase in the non-cash interest expense of $186,000; an increase in the non-cash depreciation and amortization expense of $81,000; and an increase in the non-cash stock compensation expense of $31,000.
Net cash used in investing activities. Net cash used in investing activities was $128,000 for the fiscal year ended May 31, 2005, compared to net cash used in investing activities of $182,000 for the fiscal year ended December 31, 2006. The $54,000 increase in cash used in fiscal 2006 compared with fiscal 2005 was due to a $54,000 increase in cash used in the purchase of property and equipment; and a $44,000 increase in the cash used in the purchases of short-term investments; offset by a $44,000 increase in proceeds from short-term investments.
Net cash provided by investing activities was $5.3 million for the fiscal year ended May 31, 2004, compared to net cash used in investing activities of $128,000 for the fiscal year ended May 31, 2005. The $5.4 million increase in net cash used was due to a $5.9 million decrease in cash provided by the maturities of short-term investments; partially offset by a $475,000 decrease in the cash used in the purchase of property and equipment; and partially offset by a $25,000 decrease in the cash used in the purchase of short-term investments.
Net cash provided by financing activities. Net cash provided by financing activities was $3.8 million for the fiscal year ended May 31, 2005, compared to net cash provided by financing activities of $13.5 million for the fiscal year ended December 31, 2006. The $9.7 million increase in net cash provided was due to $14.0 million provided by the issuance of convertible debentures for the fiscal year 2006; partially offset by $4.1 million provided by the issuance of notes payable for fiscal year 2005; an increase of $420,000 in deferred financing costs; a decrease of $245,000 of principal payments for capital lease obligations; and a $1,000 decrease in proceeds from the issuance of common stock.
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Net cash used in financing activities was $377,000 for the fiscal year ended May 31, 2004, compared to net cash provided by financing activities of $3.8 million for the fiscal year ended May 31, 2005. The $4.2 million increase in net cash provided was due to $4.1 million provided by the issuance of a note payable for fiscal year 2005; a decrease of $60,000 in payments on the note payable; and partially offset by an increase of $11,000 in principal payments for capital lease obligations.
In April 2004, the Company signed a loan agreement with IQ for a loan facility of approximately $6.9 million (CAN$8.0 million) (the “IQ Loan Facility”). Interest expense on the IQ Loan Facility was $0 and $151,512 for the fiscal years ended May 31, 2004 and 2005, respectively, $249,235 for the seven months ended December 31, 2005 and $681,461 for the year ended December 31, 2006. We are not obligated to make interest payments on the IQ Loan Facility until August 2007 and have capitalized all interest expense related to the IQ Loan Facility. The IQ loan is repayable annually at a rate of 25% of net income per year over a period not exceeding ten years from the date of the first disbursement, which was August 19, 2004. The interest rate applicable to this loan is IQ’s own prime rate plus 1.5% (which was 8.0% at December 31, 2005 and 9.0% at December 31, 2006). In connection with this loan, we issued IQ a warrant to purchase (on an as-if exchanged basis) up to 6,837 shares of Series B redeemable convertible preferred stock, exercisable for the period from the date of the first disbursement of the funds under this loan facility, or August 19, 2004, through the first anniversary date of our final reimbursement of the IQ Loan Facility, at an exercise price of CAN$234.00 per share (or US$200.81 as of December 31, 2006). To date, IQ has not exercised this warrant. We are required to increase the number of shares into which this warrant is exercisable to reflect any dividends paid on the Series B redeemable convertible preferred stock. As a result of our payment in January 2007 of accrued dividends on the shares of Series B redeemable convertible preferred stock, upon exercise of its warrant, IQ is currently entitled to receive 8,648 shares of Series B redeemable convertible preferred stock (on an as-if exchanged basis).
Funding requirements
To date, we have not commercialized any products and have not achieved profitability. We anticipate that we will continue to incur substantial net losses for the next several years as we further develop and prepare for the commercial launch of oritavancin and develop the corporate infrastructure required to sell our product candidates and operate as a publicly traded company.
We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products unless we receive regulatory approval for commercial sale of oritavancin. We believe the net proceeds from this offering, together with our existing cash, cash equivalents and investment balances, and interest income we earn on these balances, will be sufficient to meet our anticipated cash requirements into 2009. It is difficult to predict the actual rate of product sales until the product is approved by the FDA and the specific language allowed by the FDA on the label is known. If our available cash, cash equivalents and investment balances, along with the net proceeds from this offering, are insufficient to satisfy our liquidity requirements, we will seek to sell additional equity or debt securities or enter into another credit facility. The sale of additional equity may result in dilution to our stockholders. If we raise additional funds through the issuance of debt securities, these securities would have rights senior to those of our common stock and could contain covenants that would restrict our operations. We may require additional capital beyond our currently anticipated amounts. Any such required additional capital may not be available on reasonable terms, if at all. If we are unable to