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| 8-K - FORM 8-K - Durata Therapeutics, Inc. | d621896d8k.htm |
Exhibit 99.1
DURATA THERAPEUTICS, INC. REPORTS THIRD QUARTER 2013
FINANCIAL RESULTS
CHICAGO, IL, November 6, 2013 – Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced financial results for the quarter ended September 30, 2013.
Financial results for the quarter ended September 30, 2013
As of September 30, 2013, we had cash and cash equivalents plus short-term investments of $66.6 million, compared to $45.4 million at December 31, 2012. The increase was primarily due to the Company’s equity offering in the second quarter of 2013.
Net loss for the three months ended September 30, 2013 (the “2013 Quarter”) was $11.9 million, compared to a net loss of $21.8 million for the three months ended September 30, 2012 (the “2012 Quarter”).
Research and development expenses for the 2013 Quarter were $5.9 million, compared to $19.0 million for the 2012 Quarter. The $13.1 million decrease from the 2012 Quarter to the 2013 Quarter principally resulted from a decrease of $10.8 million related to clinical related trial costs as a result of our recently completed DISCOVER-1 and DISCOVER-2 clinical trials and a reduction of $3.1 million related to chemistry, manufacturing and control (“CMC”) related expenses due to decreased costs related to the manufacture of product in the 2013 Quarter. These reductions were partially offset by an increase of $0.6 million in personnel costs and $0.2 million of consulting costs related to the preparation of our New Drug Application (“NDA”) submission.
General and administrative expense for the 2013 Quarter was $4.8 million, compared to $2.6 million for the 2012 Quarter. The $2.2 million increase from the 2012 Quarter to the 2013 Quarter principally resulted from an increase of $1.8 million related to additional headcount and an increase of $0.5 million for marketing and medical affairs spending to support the anticipated commercial launch of dalbavancin.
Q3 2013 Highlights and Recent Events
Recent accomplishments include the following:
| • | Submitted our NDA to the U.S. Food and Drug Administration (“FDA”) seeking approval for the marketing and sale of dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections (“ABSSSI”) caused by susceptible Gram-positive microorganisms, including methicillin resistant Staphylococcus aureus (“MRSA”). |
| • | On October 31, 2013, we and our subsidiaries entered into a credit agreement with PDL BioPharma, Inc. (“PDL”), which provides for up to $70.0 million in debt financing. We used the first funding tranche of $25.0 million to repay amounts owed to Oxford Finance LLC (“Oxford”) under our former loan agreement with Oxford, with the remaining funds available for working capital purposes. Upon FDA approval of dalbavancin prior to December 31, 2014, another $15 million will be funded to us within five days of such approval. In addition, we may borrow up to $30.0 million, at our option, for up to nine months following FDA approval. |
| • | Released and presented results from the DISCOVER-1 and DISCOVER-2 programs, which showed dalbavancin met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, as well as clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever and systemic inflammatory response syndrome. |
“Durata has accomplished many things in less than a year – from completing two Phase 3 trials that met all its primary and secondary endpoints to our most recent achievement of submitting our NDA for dalbavancin, as well as strengthening our financial position to enhance our commercialization efforts,” said Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc. “Hitting these major milestones bring dalbavancin closer to market and, importantly, to patients.”
Conference Call and Webcast Information
The company will host a conference call today, November 6, 2013 at 8:30 AM EST. To access the call, please dial 866-632-4021 for participants in the U.S. or Canada and 404-991-3968 for international callers (reference Conference ID 86272586). A replay of the call may be accessed through November 20, 2013 by dialing 800-585-8367 for callers in the U.S. and Canada and 404-537-3406 for international callers (reference Conference ID 86272586). The conference call will also be webcast live on the Investor Relations section of the Company’s website at www.duratatherapeutics.com.
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 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 two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria.
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 FDA approval for dalbavancin and the ability to obtain additional funds from PDL and the potential impact of dalbavancin’s dosing schedule on hospital costs and readmissions. 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.
Investor Relations and Public Affairs Contact
Allison Wey
Durata Therapeutics, Inc.
Vice President, Investor Relations and Public Affairs
(312) 219-7017
awey@duratatherapeutics.com
Media Relations Contact
Geoff Curtis
DJE Science
(312) 233-1253
geoff.curtis@djescience.com
DURATA THERAPEUTICS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Consolidated Balance Sheet
(in thousands)
(Unaudited)
| September 30, 2013 |
December 31, 2012 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 44,485 | $ | 32,257 | ||||
| Short-term investments |
22,108 | 13,094 | ||||||
| Prepaid expenses and other current assets |
3,039 | 5,844 | ||||||
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| Total current assets |
69,632 | 51,195 | ||||||
| Acquired in process research and development |
15,292 | 15,292 | ||||||
| Goodwill |
5,811 | 5,811 | ||||||
| Property and equipment, net |
962 | 981 | ||||||
| Restricted cash |
1,146 | 852 | ||||||
| Deferred charge |
11,487 | 12,417 | ||||||
| Other assets |
512 | — | ||||||
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| Total assets |
$ | 104,842 | $ | 86,548 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 2,729 | $ | 8,618 | ||||
| Accrued expenses |
6,237 | 10,602 | ||||||
| Current portion of long-term debt |
2,841 | — | ||||||
| Income taxes payable |
32 | 2,281 | ||||||
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| Total current liabilities |
11,839 | 21,501 | ||||||
| Long-term debt (less unamortized debt discount of $1,286 at September 30, 2013) |
15,873 | — | ||||||
| Non-current tax payable |
1,358 | 1,117 | ||||||
| Contingent consideration |
20,675 | 19,836 | ||||||
| Accrued interest liability |
1,190 | — | ||||||
| Other liabilities |
482 | 222 | ||||||
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| Total liabilities |
51,417 | 42,676 | ||||||
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| Total stockholders’ equity |
53,425 | 43,872 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 104,842 | $ | 86,548 | ||||
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DURATA THERAPEUTICS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
| Three month period ended September 30, |
Nine month period ended September 30, |
Period from inception (November 4, 2009) to September 30, |
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| 2013 | 2012 | 2013 | 2012 | 2013 | ||||||||||||||||
| Operating expenses: |
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| Research and development expenses |
$ | 5,928 | $ | 18,956 | $ | 30,198 | $ | 42,255 | $ | 117,042 | ||||||||||
| General and administrative expenses |
4,824 | 2,552 | 13,388 | 6,166 | 31,170 | |||||||||||||||
| Acquisition related charges, net |
266 | 277 | 839 | 817 | 9,383 | |||||||||||||||
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| Operating loss |
11,018 | 21,785 | 44,425 | 49,238 | 157,595 | |||||||||||||||
| Other (income) expense |
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| Interest expense |
647 | 0 | 1,410 | 0 | 1,410 | |||||||||||||||
| Interest income |
(23 | ) | (11 | ) | (49 | ) | (18 | ) | (107 | ) | ||||||||||
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| Total other income (expense) |
624 | (11 | ) | 1,361 | (18 | ) | 1,303 | |||||||||||||
| Loss before income tax benefit |
11,642 | 21,774 | 45,786 | 49,220 | 158,898 | |||||||||||||||
| Income tax expense (benefit) |
257 | 0 | 715 | 0 | (5,096 | ) | ||||||||||||||
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| Net loss |
$ | (11,899 | ) | $ | (21,774 | ) | $ | (46,501 | ) | $ | (49,220 | ) | $ | (153,802 | ) | |||||
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| Net loss per common share – Basic and Diluted |
$ | (0.45 | ) | $ | (1.47 | ) | $ | (1.99 | ) | $ | (9.83 | ) | ||||||||
| Weighted average common shares – Basic and Diluted |
26,620,497 | 14,781,419 | 23,416,091 | 5,008,367 | ||||||||||||||||