In addition, Infinity is evaluating the accounting treatment for non-cash items associated with the restructuring of its strategic alliance agreements with Mundipharma and Purdue, which include approximately $54 million of deferred revenue from Purdue entities and $39 million of long-term debt due to Purdue entities, net of debt discount as of June 30, 2012. Infinity plans to review its non-cash accounting for these items with the Securities and Exchange Commission and expects to provide financial guidance for revenue and net loss later in 2012. Today, Infinity is providing 2012 financial expectations for operating expenses and year-end cash and investments.
- Operating expenses: Infinity expects operating expenses for 2012 to range from $135 million to $145 million, revised from an earlier expectation of $145 million to $155 million.
- Cash and investments: Infinity expects to end 2012 with a year-end cash and investments balance ranging from $65 million to $75 million, revised from an earlier expectation of $75 million to $85 million.
In the absence of additional funding or business development activities and based on Infinity’s current success-based operating plans for its oncology and inflammation programs and savings from recent cost-cutting initiatives, the company expects that its current cash and investments, together with proceeds from the planned equity investment of $27.5 million by PPLP, are sufficient to fund its planned operations into the second half of 2013. Importantly, Infinity has current cash runway through key data readouts that are expected from the current trials of IPI-145 in patients with advanced hematologic malignancies and of retaspimycin hydrochloride plus docetaxel in patients with NSCLC.
Conference Call Information
Infinity will host a conference call today, Tuesday, August 7, 2012, at 8:30 a.m. ET to discuss these financial results and provide an update on the company. A live webcast of the conference call can be accessed in the “investors/media” section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 12570388. An archived version of the webcast will be available on Infinity’s website for 30 days.About Infinity Pharmaceuticals, Inc. Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs focused on the inhibition of phosphoinositide-3-kinase, heat shock protein 90 and fatty acid amide hydrolase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at www.infi.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include those regarding the ability to select the optimal mix of financing and new strategic alliances to advance Infinity’s portfolio of product candidates, the expectation that Infinity will begin a Phase 2a study of IPI-145 in patients with rheumatoid arthritis during the fourth quarter of 2012, the expectation that Infinity’s Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies will expand to additional cohorts (T-cell lymphomas, diffuse large B-cell lymphoma, acute lymphocytic leukemia and myeloproliferative neoplasms) once the maximum tolerated dose is determined, the expectation that Infinity will present data from its Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies in the second half of 2012, the expectation that Infinity will present additional details from its Phase 1 study in healthy volunteers at a medical meeting in the second half of 2012, the expectation that enrollment of the trial evaluating retaspimycin HCl and docetaxel will complete this fall and that Infinity will report data from this trial in the first half of 2013, the expectation that Infinity will incur an estimated $2.5 million in restructuring charges during 2012 and the expectation that Infinity will realize cost savings beginning in 2013 from its 2012 restructuring activities. Such forward-looking statements also include 2012 financial expectations (including operating expenses and year-end cash and investments balance), the expectation that Infinity’s current cash and investments, together with proceeds from the planned equity investment of $27.5 million by PPLP, are sufficient to fund its planned operations through key data readouts into the second half of 2013 and the expectation that Infinity will provide financial guidance for revenue and net loss later in 2012. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that Infinity will be able to complete the transactions contemplated in the securities purchase agreement with Purdue Pharma L.P. and certain associated entities, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations could also be affected by risks and uncertainties relating to: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q for the quarter ended June 30, 2012, filed with the Securities and Exchange Commission on August 7, 2012. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets ( unaudited) (in thousands)|
|June 30, 2012||December 31, 2011|
|Cash, cash equivalents and available-for-sale securities, including long term||$||104,559||$||115,937|
|Other current assets||3,368||2,703|
|Property and equipment, net||3,939||4,582|
|Other long-term assets||1,183||1,268|
|Long-term debt due to Purdue entities, net of debt discount||38,927||37,553|
|Deferred revenue from Purdue entities, less current portion||40,040||42,147|
|Other long-term liabilities||387||371|
|Total stockholders’ equity (deficit)||(3,392||)||15,433|
|Total liabilities and stockholders’ equity (deficit)||$||113,049||$||124,490|
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations ( unaudited) (in thousands, except share and per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Collaborative research and development revenue from Purdue entities||$||21,911||$||19,957||$||47,113||$||47,143|
|Research and development||28,532||24,993||57,083||49,271|
|General and administrative||7,666||6,330||14,477||11,205|
|Total operating expenses||36,198||31,323||71,560||60,476|
|Loss from operations||(14,287||)||(11,366||)||(24,447||)||(13,333||)|
|Other income (expense):|
|Income from Massachusetts tax incentive award||193||—||193||—|
|Interest and investment income||127||69||247||162|
|Total other expense||(374||)||(364||)||(935||)||(704||)|
|Basic and diluted loss per common share||$||(0.54||)||$||(0.44||)||$||(0.94||)||$||(0.53||)|
|Basic and diluted weighted average number of common shares outstanding||27,061,435||26,567,980||26,919,146||26,552,102|
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