ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today reported financial results for the three-month period ended December 31, 2012 – the second quarter of the Company’s 2013 fiscal year – and provided an update on the Company.
“We expect 2013 to be a very important year for ImmunoGen,” commented Daniel Junius, President and CEO. “Roche is anticipating the approval of T-DM1 in the US early this year followed by approval in Europe later in 2013. We believe the launch of T-DM1 will be momentous for appropriate patients, their families, and their physicians. It will also mark the start of ImmunoGen earning what we believe will be a significant royalty stream.”
Mr. Junius continued, “We also believe that, in 2013, ImmunoGen’s progress on our proprietary pipeline will become more apparent. Over the course of the year, we expect to report clinical findings for our three lead TAP compounds and to advance our fourth, IMGN289, into clinical testing. We believe each of these compounds has the potential to be transformative to the treatment of its targeted cancer and we’ve designed development programs to advance each compound through proof of concept as promptly as possible.”
Product Pipeline Update
Financial Results and Guidance
ImmunoGen reported a net loss of $24.4 million, or $0.29 per basic and diluted share, for the quarter ending December 31, 2012 (2Q FY2013), as compared to a net loss of $12.8 million, or $0.17 per basic and diluted share, for the same quarter of the last year (2Q FY2012).
Revenues for 2Q FY2013 were $2.6 million. This compares to $7.6 million for 2Q FY2012, which included $5.0 million in milestone payments not repeated in 2Q FY2013. Revenues in 2Q FY2013 comprise $2.0 million of research and development support fees, $0.4 million of license and milestone fees, and $0.1 million of clinical material reimbursement, compared to $0.9 million, $6.0 million, and $0.6 million, respectively, for the same quarter last year.
Operating expenses for 2Q FY2013 were $27.1 million, compared to $20.4 million in the same quarter last year. Operating expenses in 2Q FY2013 include research and development expenses of $21.7 million, compared to $15.6 million in 2Q FY2012. This increase is primarily due to greater investment by the Company to aggressively advance its wholly owned product candidates, and includes increased costs for third-party production of antibody for use in clinical materials, increased clinical trial costs, and increased personnel expenses. Operating expenses also include general and administrative expenses of $5.5 million in 2Q FY2013, compared to $4.8 million in 2Q FY2012. This increase is primarily due to increased patent expenses and recruitment costs.
ImmunoGen had approximately $211.0 million in cash and cash equivalents as of December 31, 2012 and no debt. Cash used in operations was $42.7 million in the first six months of FY2013, compared with $24.0 million in the same period in FY2012. Capital expenditures were $2.0 million and $0.8 million for the first six months of FY2013 and FY2012, respectively.
ImmunoGen’s financial guidance remains unchanged from that issued in October 2012. ImmunoGen expects its net loss for its fiscal year ending June 30, 2013 to be between $70 million to $74 million, its net cash used in operations to be between $78 million to $82 million, and its capital expenditures to be between $4 million to $5 million. Cash and cash equivalents at June 30, 2013 are anticipated to be between $172 million to $176 million.
“The expected approval and launch of T-DM1 will be an important milestone in ImmunoGen’s history,” commented Gregory Perry, Executive Vice President and CFO. “As sales develop, this compound should provide significant royalties that will help fund the advancement of our wholly owned product candidates.”
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to discuss the quarterly results. To access the live call by phone, dial 913-312-0721. Passcode is 8098402. The call also may be accessed through the Investor Information section of the Company's website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through February 8, 2013.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its TAP technology together with the Company’s expertise in monoclonal antibodies and tumor biology. A TAP compound uses a tumor-targeting monoclonal antibody to deliver one of ImmunoGen's purpose-developed cancer-killing agents specifically to tumor cells. Ten TAP compounds are now in clinical testing, of which three are wholly owned by the Company. Marketing applications for trastuzumab emtansine (T-DM1), the most advanced compound using ImmunoGen's TAP technology, are under review in the US and Europe. Roche is developing this compound globally under an agreement between ImmunoGen and Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com.
Herceptin® is a registered trademark of Genentech. Revlimid® is a registered trademark of Celegene Corporation.
This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the Company's net loss, cash used in operations and capital expenditures in its 2013 fiscal year; its cash and marketable securities as of June 30, 2013; the occurrence, timing and outcome of potential pre-clinical, clinical and regulatory events related to the Company's and its collaboration partners' product programs; and the presentation of preclinical and clinical data on the Company’s and collaboration partners’ product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen's and the Company's collaboration partners' research and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies, clinical trials and regulatory processes; ImmunoGen's ability to financially support its product programs; ImmunoGen's dependence on collaborative partners; industry merger and acquisition activity; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2012 and other reports filed with the Securities and Exchange Commission.
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,2012||June 30,2012|
Cash and cash equivalents
|LIABILITIES AND SHAREHOLDERS' EQUITY|
Long-term portion of deferred revenue and other long-term liabilities
Total liabilities and shareholders' equity
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months EndedDecember 31,||Six Months EndedDecember 31,|
Research and development support
License and milestone fees
Clinical materials reimbursement
Research and development
General and administrative
Total operating expenses
|Loss from operations||(24,508||)||(12,776||)||(49,756||)||(32,242||)|
Other income, net
|Net loss per common share, basic and diluted||$||(0.29||)||$||(0.17||)||$||(0.59||)||$||(0.42||)|
|Weighted average common shares outstanding, basic and diluted||84,147||76,523||83,748||76,443|
Last updated on: 25/01/2013