ImmunoGen, Inc.
Oct 25, 2013
PDF

ImmunoGen, Inc. Reports First Quarter Fiscal Year 2014 Financial Results and Provides Quarterly Update

−Quarterly Conference Call Today at 8:00 am ET−

WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today reported financial results for the three-month period ended September 30, 2013 — the first quarter of the Company's 2014 fiscal year. ImmunoGen also provided an update on Kadcyla®, the Company's wholly owned product candidates, other partner programs and the latest additions to its industry-leading ADC technology portfolio.

"Kadcyla is already making a difference for many patients in the US, and the number of countries in which it is available internationally is increasing rapidly," commented Daniel Junius, President and CEO. "We believe its lead indication provides a meaningful market opportunity for Kadcyla, with many additional indications in development by Roche."

Mr. Junius continued, "Achievements with our wholly owned clinical-stage product candidates include completion of patient enrollment in our NORTH Phase II trial with IMGN901, which keeps us on track to make next-step decisions for this product candidate by mid-2014. We are making progress with IMGN853 and expect to report disease-specific Phase I data mid next year. In 2014, we also expect to report the first clinical findings with IMGN529 and potentially the first data with our newest clinical-stage compound, our EGFR-targeting IMGN289. These different product candidates reflect many enhancements we have made to our ADC technology portfolio in recent years, and our presentations at the recent AACR-NCI-EORTC conference underscore our ongoing commitment to leadership in the ADC field."

Kadcyla (ado-trastuzumab emtansine)

Kadcyla utilizes ImmunoGen's ADC technology with Roche's Herceptin® (trastuzumab) antibody and is being developed and commercialized by Roche under an agreement with ImmunoGen. Recent developments include:

ImmunoGen Wholly Owned Product Candidates

IMGN901 is in Phase II testing for the first-line treatment of extensive disease small-cell lung cancer. An ADC, IMGN901 targets CD56.

IMGN853 is a folate receptor α (FRα)-targeting ADC in Phase I testing for the treatment of FRα-positive solid tumors, which include many ovarian and endometrial cancers as well as certain non-small cell lung cancers.

IMGN289 is an EGFR-targeting ADC and ImmunoGen's third wholly owned compound for solid tumor indications. It is a potential new treatment for squamous cell lung, head and neck, and other EGFR-positive cancers, including those resistant to EGFR inhibition.

IMGN529, ImmunoGen's lead compound for hematological malignancies, is in Phase I testing for the treatment of non-Hodgkin lymphoma (NHL). An ADC, IMGN529 targets CD37, which is also on chronic lymphocytic leukemia.

Other Partner Programs

Multiple leading companies in oncology are developing anticancer compounds through partnerships with ImmunoGen. Companies licensing limited rights to use ImmunoGen's ADC technology include Amgen, Bayer HealthCare, Biotest, Eli Lilly, Novartis, Roche and Sanofi. In addition to Kadcyla, seven other compounds are in clinical testing through ImmunoGen's collaborative partnerships.

The first clinical data for SAR566658 were reported at an AACR-NCI-EORTC conference earlier this month.

ImmunoGen ADC Technology

There is notable clinical support for ImmunoGen's tubulin-acting maytansinoid ADC technology, including the findings in Phase II and III randomized trials with Kadcyla as well as Phase I findings for multiple product candidates.

The Company continues to further augment its technology portfolio to extend the potential for effective, well-tolerated ADCs while maintaining its leadership in the field.

Financial Results

For the Company's quarter ended September 30, 2013 (1Q FY2014), ImmunoGen reported a net loss of $11.2 million, or $0.13 per basic and diluted share, compared to a net loss of $25.2 million, or $0.30 per basic and diluted share, for the same quarter last year (1Q FY2013).

Revenues for 1Q FY2014 were $17.2 million, compared to $4.1 million for 1Q FY2013. Revenues in the current period include $13.2 million of license and milestone fees, compared to $0.9 million in 1Q FY2013. The FY2014 fees include $7.8 million of amortization of upfront license fees from Lilly that were recognized due to Lilly taking a development and commercialization license in August 2013. They also include a $5.0 million milestone from Roche earned with the approval of Kadcyla in Japan. Revenues in 1Q FY2014 also include $2.1 million of royalty payments received from Roche in September 2013 for sales of Kadcyla during the three-month period ended June 30, 2013, $2.0 million of research and development support fees, compared to $1.4 million in such fees for 1Q FY2013, and negligible clinical materials revenue, compared to $1.8 million for 1Q FY2013. The differences in support fees and clinical material revenue are primarily due to the variable nature in the amount of research and in the number of batches of clinical materials produced and released to partners on a quarter-to-quarter basis.

Operating expenses in 1Q FY2014 were $28.6 million, compared to $29.3 million in 1Q FY2013. Operating expenses in 1Q FY2014 include research and development expenses of $22.0 million, compared to $23.7 million in 1Q FY2013. This change is primarily due to the sale of less clinical materials to our partners and thus lower associated expenses and to less cost for third-party production of antibody for use in our own clinical materials, partially offset by increased personnel expenses. Operating expenses also include general and administrative expenses of $6.5 million in 1Q FY2014, compared to $5.6 million in 1Q FY2013. This increase is primarily due to increased personnel expenses, including severance expense related to the departure of the former chief financial officer.

ImmunoGen had approximately $174.8 million in cash and cash equivalents as of September 30, 2013, compared with $195.0 million as of June 30, 2013, and had no debt outstanding in either period. Cash used in operations was $23.6 million in the first three months of FY2014, compared with $21.0 million in the same period in FY2013. Capital expenditures were $0.6 million and $1.0 million for the first three months of FY2014 and FY2013, respectively.

Updated Financial Guidance for FY 2014

ImmunoGen is updating its financial guidance for FY2014 from that issued in August 2013. ImmunoGen now expects:

The changes in projected revenue, net loss, cash used in operations, and ending cash and cash equivalents principally reflect the milestone payment earned with approval of Kadcyla in Japan, which had not been anticipated to occur during this fiscal year.

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 913-981-5507; the passcode is 2847961. 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 November 8, 2013.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's ADC technology uses a tumor-targeting engineered antibody to deliver one of ImmunoGen's highly potent cancer-cell killing agents specifically to tumor cells. The most advanced compound with ImmunoGen's ADC technology is Roche's Kadcyla, which is marketed in the US by Genentech and is also gaining approvals internationally. ImmunoGen has four wholly owned clinical-stage product candidates, with additional compounds in the clinic through its partnerships with Amgen, Bayer HealthCare, Biotest and Sanofi. More information about the Company can be found at www.immunogen.com.

Kadcyla® and Herceptin® are registered trademarks of Genentech, a member of the Roche Group.

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 revenues, operating expenses, net loss, cash used in operations and capital expenditures in its 2014 fiscal year; its cash and marketable securities as of June 30, 2014; 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; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2013 and other reports filed with the Securities and Exchange Commission.

-Financials Follow-

IMMUNOGEN, INC.
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
                     
September 30,
2013
June 30,
2013
 
ASSETS
 
Cash and cash equivalents $ 174,838 $ 194,960
Other assets   25,186     18,636  
 
Total assets $ 200,024   $ 213,596  
 
LIABILITIES AND SHAREHOLDERS' EQUITY
 
Current liabilities $ 16,541 $ 19,173
Long-term portion of deferred revenue and other long-term liabilities 64,042 72,576
Shareholders' equity   119,441     121,847  
 
Total liabilities and shareholders' equity $ 200,024   $ 213,596  
 
 
 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended
September 30,
 
2013   2012
 
Revenues:
License and milestone fees $ 13,167 $ 933
Royalty revenue 2,053 -
Research and development support 1,990 1,377
Clinical materials revenue   8     1,781  
 
Total revenues   17,218     4,091  
 
Expenses:
Research and development 22,029 23,700
General and administrative   6,526     5,639  
 
Total operating expenses   28,555     29,339  
 
Loss from operations (11,337 ) (25,248 )
 
Other income, net   111     56  
 
Net loss $ (11,226 ) $ (25,192 )
 

Net loss per common share, basic and diluted

$ (0.13 ) $ (0.30 )
 
 

Weighted average common shares outstanding, basic and diluted

85,010

    83,350  

For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For Media:
The Yates Network
Barbara Yates, 781-258-6153

Source: ImmunoGen, Inc.

News Provided by Acquire Media