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| 8-K - FORM 8-K - Durata Therapeutics, Inc. | d433936d8k.htm |
Exhibit 99.1
DURATA THERAPEUTICS REPORTS THIRD QUARTER 2012 FINANCIAL AND CORPORATE RESULTS
MORRISTOWN, NJ, November 9, 2012 – Durata Therapeutics (NASDAQ: DRTX) today announced financial and corporate results for the quarter ended September 30, 2012.
“With the completion of patient enrollment in our two ongoing global Phase 3 clinical trials of dalbavancin, we remain on track to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2013, pending results from these trials,” said Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc. “Our financial results reflect our increase in spending as the studies draw to a close.”
Recent Accomplishments
Our significant recent accomplishments include the following:
| • | Completed target enrollment for both of our global Phase 3 clinical trials of dalbavancin. |
| • | Received Qualified Infectious Disease Product (QIDP) designation for dalbavancin from the FDA, which provides Durata priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). |
| • | Completed QT study of dalbavancin, which indicated that dalbavancin had no clinically significant impact on cardiac conduction. |
| • | Released in vitro study data that could help support a clinical development program to investigate dalbavancin for the treatment of pneumonia. |
Financial results for the quarter ended September 30, 2012
As of September 30, 2012, we had cash and cash equivalents of $60.8 million, compared to $11.5 million at December 31, 2011. In July 2012, we raised $73.9 million in net proceeds from our initial public offering.
Net loss for the three months ended September 30, 2012 (the “2012 Quarter”) was $21.8 million, compared to net loss of $9.4 million for the three months ended September 30, 2011 (the “2011 Quarter”).
Research and development expense for the 2012 Quarter was $19.0 million, compared to $8.3 million for the 2011 Quarter. The $10.7 million increase from the 2011 Quarter to the 2012 Quarter principally resulted from an increase of $7.6 million in contract research organization and other clinical trial expenses, including consulting, an increase of $0.5 million for personnel costs to support our studies and an increase of $2.6 million related to chemistry, manufacturing and control related expenses due to the production of active product ingredient to support registration batches.
General and administrative expense for the 2012 Quarter was $2.6 million, compared to $1.0 million for the 2011 Quarter. The $1.6 million increase from the 2011 Quarter to the 2012 Quarter principally resulted from an increase of $0.7 million for personnel costs, an increase of $0.4 million in legal and consulting fees and an increase of $0.5 million for insurance and other operating expenses to support our pre-launch activities and increased compliance requirements.
About Dalbavancin
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI, in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed enrollment in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with ABSSSI.
Forward-looking statements
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward looking statements in this press release include statements about the filing of a New Drug Application with the U.S. Food and Drug Administration. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the “Risk Factors” section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
Contacts
Investor Relations and Public Affairs Contact
Durata Therapeutics
Allison Wey
Vice President, Investor Relations and Public Affairs
(312) 612-5462
awey@duratatherapeutics.com
or
Media Relations Contacts
Jed Weiner
White Oak Communications, Inc.
(847) 392-4186
jed.weiner@comcast.net
DURATA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
Condensed Consolidated Balance Sheet
Unaudited
(in thousands)
| December 31, 2011 |
September 30, 2012 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 11,485 | $ | 60,790 | ||||
| Prepaid expenses and other current assets |
997 | 1,351 | ||||||
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| Total current assets |
12,482 | 62,141 | ||||||
| Acquired in process research and development |
15,292 | 15,292 | ||||||
| Goodwill |
5,811 | 5,811 | ||||||
| Property and equipment, net |
— | 507 | ||||||
| Restricted cash |
— | 850 | ||||||
| Deferred charge |
— | 10,991 | ||||||
| Other assets |
40 | — | ||||||
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| Total assets |
$ | 33,625 | $ | 95,592 | ||||
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| Liabilities, Redeemable Preferred Stock and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 1,957 | $ | 6,659 | ||||
| Accrued expenses |
1,369 | 8,579 | ||||||
| Income taxes payable |
— | 2,841 | ||||||
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| Total current liabilities |
3,326 | 18,079 | ||||||
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| Non-current income tax payable |
— | 1,000 | ||||||
| Contingent consideration |
18,739 | 19,556 | ||||||
| Other liabilities |
— | 89 | ||||||
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| Total liabilities |
22,065 | 38,724 | ||||||
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| Redeemable portion—Series A Convertible Preferred Stock |
6,000 | — | ||||||
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| Total stockholders’ equity |
5,560 | 56,868 | ||||||
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| Total liabilities, redeemable preferred stock and stockholders’ equity |
$ | 33,625 | $ | 95,592 | ||||
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DURATA THERAPEUTICS, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statement of Operations
(Unaudited)
(in thousands, except share and per share data)
| Period from inception (November 4, 2009) to |
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| Three Month Period Ended September 30, | Nine Month Period Ended September 30, | September 30, | ||||||||||||||||||
| 2011 | 2012 | 2011 | 2012 | 2012 | ||||||||||||||||
| Operating expenses: |
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| Research and development expenses |
$ | 8,325 | $ | 18,956 | $ | 21,094 | $ | 42,255 | $ | 77,404 | ||||||||||
| General and administrative expenses |
1,009 | 2,553 | 3,313 | 6,166 | 14,160 | |||||||||||||||
| Acquisition related charges, net |
760 | 277 | 357 | 817 | 8,264 | |||||||||||||||
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| Operating loss |
10,094 | 21,786 | 24,764 | 49,238 | 99,828 | |||||||||||||||
| Interest income |
(2 | ) | (12 | ) | (11 | ) | (19 | ) | (36 | ) | ||||||||||
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| Loss before income tax benefit |
10,092 | 21,774 | 24,753 | 49,219 | 99,792 | |||||||||||||||
| Income tax benefit |
(706 | ) | — | (1,489 | ) | — | (5,811 | ) | ||||||||||||
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| Net loss |
$ | (9,386 | ) | $ | (21,774 | ) | $ | (23,264 | ) | $ | (49,219 | ) | $ | (93,981 | ) | |||||
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| Net loss attributable to common stockholders |
$ | (9,386 | ) | $ | (21,774 | ) | $ | (23,264 | ) | $ | (49,219 | ) | $ | (93,981 | ) | |||||
| Net income attributable to Series A preferred stockholders |
— | — | — | — | — | |||||||||||||||
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| Net loss |
$ | (9,386 | ) | $ | (21,774 | ) | $ | (23,264 | ) | $ | (49,219 | ) | $ | (93,981 | ) | |||||
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| Net loss per common share – Basic and Diluted |
$ | (150.18 | ) | $ | (1.47 | ) | $ | (394.12 | ) | $ | (9.83 | ) | ||||||||
| Weighted-average common shares – Basic and Diluted |
62,500 | 14,781,419 | 59,028 | 5,008,367 | ||||||||||||||||