ImmunoGen, Inc.
Jan 30, 2015
PDF

ImmunoGen, Inc. Reports Second Quarter Fiscal Year 2015 Financial Results

− 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 December 31, 2014 - the second quarter of the Company's 2015 fiscal year (2QFY2015). ImmunoGen also provided an update on product programs and reiterated its financial guidance.

"We believe the potential of ImmunoGen as a product company will become more clearly established in 2015, driven by achievements with our most advanced compounds, IMGN853 and IMGN529," commented Daniel Junius, President and CEO. "We are preparing to expand the IMGN853 clinical program markedly this year based on the encouraging clinical findings to date, which are being submitted for presentation at the ASCO annual meeting. We expect to initiate assessment of IMGN529 specifically in the treatment of diffuse large B-cell lymphoma - building on the promising data reported at ASH last month - and in chronic lymphocytic leukemia, and to present more mature clinical findings later in the year."

Mr. Junius continued, "In 2015, Roche expects the presentation of the data from its MARIANNE breast cancer trial as well as the read out from its GATSBY gastric cancer trial, which should lead to a better understanding of the potential opportunity for Kadcyla in the patient populations studied. We expect the potential of several earlier-stage partner compounds to become better established in 2015, and three-to-four more to enter the clinic. The first of these, Novartis' LOP628, started Phase 1 testing earlier this month."

ImmunoGen Wholly Owned Product Candidates

IMGN853 - This ADC is currently in initial (Phase 1b) efficacy testing for the treatment of folate receptor α (FRα)-positive platinum-resistant ovarian cancer and relapsed/refractory endometrial cancer. It is being assessed as a single agent, administered once every three weeks at its recommended Phase 2 dose (RP2D).

IMGN529 - This CD37-targeting ADC is a potential new treatment for diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies. It is in dose-finding assessment in patients with non-Hodgkin lymphoma (NHL), with encouraging evidence of activity in patients with relapsed/refractory DLBCL presented at the American Society of Hematology (ASH) annual meeting in December.

IMGN289 - This ADC is a potential new treatment for EGFR-positive cancers, which include many head and neck, lung, breast, stomach and esophageal cancers.

IMGN779 - This CD33-targeting ADC is a potential new treatment for acute myeloid leukemia. It utilizes one of ImmunoGen's new DNA-acting payload agents.

Technology innovations - The Company expects to report information related to the ongoing expansion of its state-of-the-art technology portfolio at the American Association of Cancer Research (AACR) annual meeting in April. Numerous abstracts were submitted to this conference on ImmunoGen and partner compounds.

Partner Compounds

Roche's Kadcyla (ado-trastuzumab emtansine), which uses ImmunoGen's ADC technology, is the only ADC with full FDA approval (EMILIA Phase 3 trial).

Other leading companies are advancing clinical-stage compounds that use ImmunoGen technology - Amgen, Bayer HealthCare, Biotest, Novartis and Sanofi. Recent updates include:

In 2015, ImmunoGen expects:

Financial Results

For the Company's quarter ended December 31, 2014 (2QFY2015), ImmunoGen reported net income of $13.6 million, or $0.16 per basic and diluted share, compared to net income of $3.8 million, or $0.04 per basic and diluted share, for the same quarter last year (2QFY2014).

Revenues for 2QFY2015 were $48.3 million, compared to $30.1 million for 2QFY2014. Revenues in the current period include $41.4 million of license and milestone fees, compared to $25.7 million in 2QFY2014. The current year fees include $41.4 million of amortization of upfront fees, in aggregate, previously received from Novartis and Lilly that were recognized in 2QFY2015 due to their license activity in the period. The prior year period includes $18.2 million of amortization of upfront fees previously received from Novartis that were recognized in 2QFY2014 due to Novartis license activity and its executing an extension of its multi-target agreement with the Company. They also include a $5 million cash milestone payment earned from Roche with the approval of Kadcyla in the EU and $2.2 million of amortization of upfront license fees from Amgen.

Revenues in 2QFY2015 include $4.6 million of royalty payments received from Roche in December 2014 for sales of Kadcyla during the three-month period ended September 30, 2014, compared to $2.3 million of royalty payments received in 2QFY2014. Additionally, 2QFY2015 revenues include $0.8 million of research and development support fees, compared to $1.9 million in such fees for 2QFY2014, and $1.4 million of clinical materials revenue, compared to $0.1 million for 2QFY2014. The level of research support and the number of batches of clinical materials produced and released to partners varies on a quarter-to-quarter basis.

Operating expenses in 2QFY2015 were $34.5 million, compared to $26.3 million in 2QFY2014. Operating expenses in 2QFY2015 include research and development expenses of $27.6 million, compared to $20.9 million in 2QFY2014. This change is primarily due to increased third-party costs related to the advancement of our internal products, increased costs associated with manufacturing clinical materials on behalf of our partners and increased personnel expenses, principally due to recent hiring. Operating expenses also include general and administrative expenses of $6.9 million in 2QFY2015, compared to $5.4 million in 2QFY2014. This increase is primarily due to increased personnel and patent expenses.

ImmunoGen had approximately $106.6 million in cash and cash equivalents as of December 31, 2014, compared with $142.3 million as of June 30, 2014, and had no debt outstanding in either period. Cash used in operations was $34.4 million in the first six months of FY2015, compared with $21.6 million in the same period in FY2014. Capital expenditures were $2.6 million and $2.3 million for the first six months of FY2015 and FY2014, respectively.

Financial Guidance for Fiscal Year 2015

ImmunoGen's financial guidance remains unchanged from that issued in October 2014. ImmunoGen expects: its revenues to be between $100 million and $105 million; its operating expenses to be between $160 million and $165 million; its net loss to be between $60 million and $65 million; its cash used in operations to be between $55 million and $60 million; and its capital expenditures to be between $7 million and $9 million. Cash and marketable securities at June 30, 2015 are anticipated to be between $75 million and $85 million.

"Our financial results this quarter reflect our business model of investing in the development of our own product candidates designed to make a meaningful difference for patients with cancer, and utilizing partnerships to help fund these programs," commented David Johnston, EVP and CFO.

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 913-312-0977; the conference ID is 8510777. The call also may be accessed through the Investors 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 13, 2015.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells; the Company has also developed antibodies with anticancer activity of their own. The first product with ImmunoGen's ADC technology is Roche's Kadcyla. ImmunoGen has three wholly owned product candidates in clinical testing with additional compounds in clinical testing through the Company's partnerships with Amgen, Bayer HealthCare, Biotest, Novartis and Sanofi. More information about ImmunoGen can be found at www.immunogen.com.

Kadcyla® is a registered trademark 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 2015 fiscal year; its cash and marketable securities as of June 30, 2015; 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, 2014 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)
 
December 31, June 30,
2014 2014
ASSETS
 
Cash and cash equivalents $ 106,604 $ 142,261
Other assets   21,936     23,057
 
Total assets $ 128,540   $ 165,318
 
LIABILITIES AND SHAREHOLDERS' EQUITY
 
Current liabilities $ 19,643 $ 21,254
Long-term portion of deferred revenue and other long-term liabilities 31,427 68,365
Shareholders' equity   77,470     75,699
 
Total liabilities and shareholders' equity $ 128,540   $ 165,318
 
 
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
2014 2013 2014 2013
 
Revenues:
License and milestone fees $ 41,417 $ 25,678 $ 47,651 $ 38,845
Royalty revenue 4,625 2,335 8,791 4,388
Research and development support 832 1,922 1,608 3,912
Clinical materials revenue   1,426     125 3,453   133  
 
Total revenues   48,300     30,060 61,503   47,278  
 
Expenses:
Research and development 27,647 20,862 55,665 42,891
General and administrative   6,872     5,447 13,967   11,973  
 
Total operating expenses   34,519     26,309 69,632   54,864  
 
Income (loss) from operations 13,781 3,751 (8,129 ) (7,586 )
 
Other income, net   (146 )   62 (518 ) 172  
 
Net income (loss) $ 13,635   $ 3,813 $ (8,647 ) $ (7,414 )
 
Net income (loss) per common share, basic and diluted $ 0.16   $ 0.04 $ (0.10 ) $ (0.09 )
 
Weighted average common shares outstanding, diluted   86,665     87,276   85,904     85,221  

For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
info@immunogen.com
or
For Media:
Pure Communications, Inc.
Dan Budwick, 973-271-6085

Source: ImmunoGen, Inc.

News Provided by Acquire Media