CHICAGO, May 8, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced financial results for the quarter ended March 31, 2014.
"The first quarter of 2014 ended on a high note with the unanimous recommendation by the FDA's Anti-Infective Drugs Advisory Committee for the approval of Dalvance," said Paul R. Edick, CEO of Durata Therapeutics. "We are very focused on several major milestones, which include preparing for the May 26th action date for the FDA's review of our NDA and an anticipated launch of Dalvance in the third quarter of 2014, as well as advancing additional studies of dalbavancin, among other initiatives."
First Quarter 2014 Highlights and Recent Events
- In March 2014, the U.S. Food and Drug Administration's ("FDA") Anti-Infective Drugs Advisory Committee unanimously recommended approval of dalbavancin for the treatment of acute bacterial skin and skin structure infections ("ABSSSI"), voting 12 to 0 that we had provided substantial evidence of the safety and effectiveness of our investigational drug, Dalvance™ (dalbavancin) for injection for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, commonly referred to as MRSA.
- In April 2014, we initiated enrollment of our Phase 3b clinical trial, which we refer to as our single dose study, to evaluate the efficacy and safety of a single 1,500 mg dose of our investigational drug, Dalvance™, infused over 30 minutes in adult patients with ABSSSI caused by susceptible Gram-positive bacteria.
Financial results for the quarter ended March 31, 2014
At March 31, 2014, we had cash and cash equivalents plus short-term investments of $41.5 million, compared to $59.7 million at December 31, 2013.
Net loss as measured in accordance with U.S. generally accepted accounting principles ("GAAP") for the quarter ended March 31, 2014 was $20.0 million, compared to a net loss of $15.8 million for the quarter ended March 31, 2013. Net loss per common share-Basic and Diluted for the quarter ended March 31, 2014 and 2013, was $0.75 and $0.86, respectively. The $20.0 million loss for the quarter ended March 31, 2014 includes non-cash charges of $2.7 million for acquisition related expenses and $0.8 million of stock-based compensation. With these non-cash items excluded, the adjusted net loss for the quarter ended March 31, 2014 was $16.5 million on a non-GAAP basis. The $15.8 million loss for the quarter ended March 31, 2013 includes non-cash charges of $0.3 million for acquisition related expenses and $0.6 million of stock-based compensation. With these non-cash items excluded, the adjusted net loss for the quarter ended March 31, 2013 was $14.9 million on a non-GAAP basis. Non-GAAP loss per common share-Basic and Diluted for the quarter ended March 31, 2014 and 2013, was $0.62 and $0.81, respectively.
Research and development expenses for the quarter ended March 31, 2014 were $9.0 million, compared to $11.1 million for the quarter ended March 31, 2013. The $2.1 million decrease was due primarily to a $2.4 million decrease related to clinical trial activities following the completion of the DISCOVER trials which was partially offset by an increase in costs associated with our single dose study and a decrease of $0.6 million in consulting fees, partially offset by an increase of $0.8 million in payroll expenses as a result of increased headcount to support ongoing development of dalbavancin.
General and administrative expenses for the quarter ended March 31, 2014 were $7.2 million, compared to $4.1 million for the quarter ended March 31, 2013. The $3.1 million increase was due to a $2.2 million increase for personnel costs related to our continued expansion efforts in preparation for the anticipated commercial launch of dalbavancin, an increase of $0.7 million for consultancy related to commercial planning activities and an increase of $0.2 million for occupancy and other operating expenses.
Use of Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with GAAP, the company uses the following non-GAAP financial measures: non-GAAP net loss and non-GAAP net loss per common share-basic and diluted (collectively the "non-GAAP financial measures"). The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. The company uses these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. The company believes that the non-GAAP financial measures provide useful information about operating results, enhance the overall understanding of past financial performance, and allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.
The company excludes the following items from one or more of its non-GAAP measures:
Stock-based compensation. The company excludes stock-based compensation because it is non-cash in nature and because the company believes that the non-GAAP financial measures excluding this item provide meaningful supplemental information regarding operational performance and liquidity. The company further believes this measure is useful to investors to facilitate comparisons to historical operating results and comparisons to peer operating results.
Acquisition related charges, net. The company excludes acquisition related charges, net because the charges are non-cash in nature and because the company believes that the non-GAAP financial measures excluding this item provide meaningful supplemental information regarding operational performance and liquidity. In addition, excluding this item from the non-GAAP measures facilitates internal comparisons to historical operating results and comparisons to peer operating results.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" table in this press release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
Conference Call and Webcast Information
The company will host a conference call today, May 8, 2014, 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 34955177). A replay of the call may be accessed through May 22, 2014 by dialing 800-585-8367 for callers in the U.S. and Canada and 404-537-3406 for international callers (reference Conference ID 34955177). The conference call will also be webcast live on the Investor Relations section of the Company's website at www.duratatx.com.
About Dalvance
Dalvance is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. If approved, Dalvance would be the first drug for ABSSSI requiring only two once-weekly 30-minute intravenous doses (1,000 mg on Day 1 and 500 mg on Day 8). Dalvance demonstrates bactericidal activity in vitro against a broad range of bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of new therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, Dalvance™, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria. For more information about the company, visit www.duratatx.com.
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 FDA's review and approval status of Dalvance and the potential impact of developing dalbavancin for additional indications and new dosing strategies and formulations. 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 annual report on Form 10-K, which is on file with the SEC and is also available on our website, and in our other filings with the SEC. 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.
| DURATA THERAPEUTICS, INC. AND SUBSIDIARIES | ||
| (A Development Stage Company) | ||
| Consolidated Balance Sheet | ||
| (in thousands) | ||
| (Unaudited) | ||
| Assets | March 31, 2014 | December 31, 2013 |
| Current assets: | ||
| Cash and cash equivalents | $ 20,669 | $ 36,853 |
| Short-term investments | 20,872 | 22,880 |
| Prepaid expenses and other current assets | 3,955 | 3,367 |
| Total current assets | 45,496 | 63,100 |
| Acquired in process research and development | 15,292 | 15,292 |
| Goodwill | 5,811 | 5,811 |
| Property and equipment, net | 831 | 897 |
| Restricted cash | 997 | 1,147 |
| Deferred charge | 10,081 | 10,081 |
| Other assets | 3,904 | 3,816 |
| Total assets | $ 82,412 | $ 100,144 |
| Liabilities and Stockholders' Equity | ||
| Current liabilities: | ||
| Accounts payable | $ 3,204 | $ 5,275 |
| Accrued expenses | 8,912 | 7,116 |
| Current portion of long-term debt | 313 | -- |
| Income taxes payable | 573 | 1,609 |
| Total current liabilities | 13,002 | 14,000 |
| Long-term debt | 24,687 | 25,000 |
| Non-current income tax payable | 1,377 | 1,377 |
| Contingent consideration | 23,587 | 20,889 |
| Other liabilities | 289 | 299 |
| Total liabilities | 62,942 | 61,565 |
| Total stockholders' equity | 19,470 | 38,579 |
| Total liabilities and stockholders' equity | $ 82,412 | $ 100,144 |
| DURATA THERAPEUTICS, INC. AND SUBSIDIARIES | |||
| (A Development Stage Company) | |||
| Consolidated Statement of Operations | |||
| (in thousands, except share and per share data) | |||
| (Unaudited) | |||
| Period from | |||
| inception | |||
| (November 4, | |||
| Three month period ended | 2009) to | ||
| March 31, | March 31, | ||
| 2014 | 2013 | 2014 | |
| Operating expenses: | |||
| Research and development expenses | $ 9,009 | $ 11,092 | $ 133,170 |
| General and administrative expenses | 7,237 | 4,050 | 43,621 |
| Acquisition related charges, net | 2,698 | 284 | 12,295 |
| Operating loss | 18,944 | 15,426 | 189,086 |
| Other (income) expense | |||
| Interest expense | 895 | 108 | 3,121 |
| Loss on early extinguishment of debt | - | - | 2,228 |
| Interest income | (13) | (15) | (134) |
| Other income | - | - | (501) |
| Total other (income) expense | 882 | 93 | 4,714 |
| Loss before income tax expense (benefit) | 19,826 | 15,519 | 193,800 |
| Income tax expense (benefit) | 131 | 248 | (4,402) |
| Net loss | $ (19,957) | $ (15,767) | $ (189,398) |
| Net loss per common share – Basic and Diluted | $ (0.75) | $ (0.86) | |
| Weighted average common shares – Basic and Diluted | 26,633,284 | 18,367,540 | |
| DURATA THERAPEUTICS, INC. AND SUBSIDIARIES | |||
| (A Development Stage Company) | |||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES | |||
| (in thousands, except share and per share data) | |||
| (Unaudited) | |||
| Three month period ended | |||
| March 31, | |||
| 2014 | 2013 | ||
| Reconciliation of non-GAAP Net loss | |||
| GAAP Net loss | $ (19,957) | $ (15,767) | |
| Add back: | |||
| Stock-based compensation expense(1) | 779 | 558 | |
| Acquisition related charges, net(2) | 2,698 | 284 | |
| Non-GAAP Net loss | $ (16,480) | $ (14,925) | |
| Reconciliation of Net loss per common share - Basic and Diluted | |||
| GAAP Net loss per common share - Basic and Diluted | $ (0.75) | $ (0.86) | |
| Add back: | |||
| Non-GAAP adjustments | 0.13 | 0.05 | |
| Non-GAAP Net loss per common share - Basic and Diluted | $ (0.62) | $ (0.81) | |
| Weighted average common shares – Basic and Diluted | 26,633,284 | 18,367,540 | |
| (1) adjustment includes non-cash stock-based compensation expense | |||
| (2) adjustment for contingent consideration expense associated with contingent liability due to Pfizer upon regulatory approval and first commercial sale of dalbavancin. | |||