ImmunoGen, Inc.
Jan 29, 2016
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ImmunoGen Reports Second Quarter Fiscal Year 2016 Financial Results and Provides Corporate Update

− Conference Call Today at 8:00 am ET

WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its proprietary ADC technology, today reported financial results for the three-month period ended December 31, 2015 - the second quarter of the Company's 2016 fiscal year. ImmunoGen also provided an update on product programs and reiterated its 2016 fiscal year guidance.

"ImmunoGen is off to a strong start for 2016, with multiple clinical trial initiations underway," commented Daniel Junius, President and CEO. "Of particular importance is the opening of our FORWARD I trial assessing mirvetuximab soravtansine as single-agent therapy for pretreated FRα-positive ovarian cancer, which we believe is the fastest path to registration for this promising ADC. We expect several presentations of mirvetuximab soravtansine clinical data in 2016, including mature results from the 40-patient FRα-positive ovarian cancer Phase 1 cohort."

Mr. Junius continued, "Our partners also are making meaningful progress. Of particular note is Bayer's initiation of a Phase 2 trial designed to support registration of its anetumab ravtansine product candidate. Roche expects data to be reported from its trial assessing Kadcyla in the neoadjuvant setting this year and - if positive - to bring these to regulatory authorities for potential filing in 2016. A third partner compound is on track to advance into registration testing later this year."

Update on Wholly Owned Product Programs

Mirvetuximab soravtansine - First FRα-targeting ADC is a potential new treatment for ovarian cancer and other FRα-positive solid tumors.

IMGN529 and coltuximab ravtansine - CD37- and CD19-targeting, respectively, ADCs for diffuse large B-cell lymphoma (DLBCL) and potentially other B-cell malignancies.

IMGN779 - First CD33-targeting ADC utilizing an IGN cancer-killing agent. IGNs are a new class of DNA-acting agents invented by ImmunoGen.

Update on Partner Programs

Nine companies are advancing ADCs with ImmunoGen technology. Recent highlights include:

Financial Results

For the Company's quarter ended December 31, 2015 (2QFY2016), ImmunoGen reported a net loss of $(33.2) million, or $(0.38) per basic and diluted share, compared to net income of $13.6 million, or $0.16 per basic and diluted share, for the same quarter last year (2QFY2015).

Revenues for 2QFY2016 were $18.0 million, compared to $48.3 million for 2QFY2015. The current period includes $8.6 million of amortization of upfront fees previously received from Takeda and the prior year period includes $41.4 million of amortization of upfront fees previously received from Novartis and Lilly. The fees are recognized in their respective quarters due to the partner taking one or more licenses in the quarter. License and milestone fees for 2QFY2016 also include a $2 million milestone earned from Sanofi with the advancement of SAR428926 into clinical testing. Revenues in 2QFY2016 include $6.3 million of non-cash royalty revenues and $0.2 million of cash royalty revenues on Roche sales of Kadcyla for the three-months ended September 30, 2015, compared with $4.6 million in cash royalty revenues for the prior year period.

Operating expenses in 2QFY2016 were $46.3 million, compared to $34.5 million in 2QFY2015. Operating expenses in 2QFY2016 include research and development expenses of $38.2 million, compared to $27.6 million in 2QFY2015. This change is primarily due to increased third-party costs related to the advancement of our wholly owned product candidates, increased clinical trial costs, primarily related to our expansion of the mirvetuximab soravtansine development program, and increased personnel expenses, principally due to recent hiring. Operating expenses include general and administrative expenses of $8.1 million in 2QFY2016, compared to $6.9 million in 2QFY2015. This increase is primarily due to increased personnel expenses and professional services.

ImmunoGen had approximately $212.3 million in cash and cash equivalents as of December 31, 2015, compared with $278.1 million as of June 30, 2015, and had no debt outstanding in either period. Cash used in operations was $63.0 million in the first six months of FY2016, compared with $34.4 million in the same period in FY2015. Capital expenditures were $7.6 million and $2.6 million for the first six months of FY2016 and FY2015, respectively.

Financial Guidance for Fiscal Year 2016

ImmunoGen's financial guidance remains unchanged from that issued in July 2015. ImmunoGen expects: its revenues to be between $70 million and $80 million; its operating expenses to be between $175 million and $180 million; its net loss to be between $120 million and $125 million; its cash used in operations to be between $100 million and $105 million; and its capital expenditures to be between $13 million and $15 million. Cash and cash equivalents at June 30, 2016 are anticipated to be between $165 million and $170 million.

Conference Call Information

ImmunoGen is holding a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 913-312-0836; the conference ID is 5851737. 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 12, 2016.

About ImmunoGen, Inc.

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary ADC technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. A number of major healthcare companies have licensed rights to use ImmunoGen's ADC technology to develop novel anticancer therapies; it is used in Roche's marketed product, Kadcyla®. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

ProbodyTM is a trademark of CytomX Therapeutics, Inc.

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 2016 fiscal year; its cash and marketable securities as of June 30, 2016; 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, 2015 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,
  2015     2015  
ASSETS
 
Cash and cash equivalents $ 212,283 $ 278,109
Other assets   39,297     35,714  
 
Total assets $ 251,580   $ 313,823  
 
LIABILITIES AND SHAREHOLDERS' EQUITY
 
Current liabilities $ 43,900 $ 35,810
Long-term portion of deferred revenue and other long-term liabilities 224,366 242,909
Shareholders' equity   (16,686 )   35,104  
 
Total liabilities and shareholders' equity $ 251,580   $ 313,823  
 
 
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
December 31, December 31,
  2015       2014     2015       2014  
 
Revenues:
License and milestone fees $ 10,692 $ 41,417 $ 16,762 $ 47,651
Royalty revenue 195 4,625 195 8,791
Non-cash royalty revenue 6,291 - 11,975 -
Research and development support 848 832 1,620 1,608
Clinical materials revenue   3     1,426     2,328     3,453  
 
Total revenues   18,029     48,300     32,880     61,503  
 
Expenses:
Research and development 38,199 27,647 73,331 55,665
General and administrative   8,054     6,872     16,383     13,967  
 
Total operating expenses   46,253     34,519     89,714     69,632  
 
(Loss) income from operations (28,224 ) 13,781 (56,834 ) (8,129 )
 
Non-cash interest expense on liability related to sale of future royalty (5,059 ) - (10,202 ) -
Other income (loss), net   56     (146 )   69     (518 )
 
Net (loss) income $ (33,227 ) $ 13,635   $ (66,967 ) $ (8,647 )
 
Net (loss) income per common share, basic and diluted $ (0.38 ) $ 0.16   $ (0.77 ) $ (0.10 )
 
 
Weighted average common shares outstanding, diluted   86,970     86,665     86,904     85,904  

For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
info@immunogen.com
or
For Media:
For ImmunoGen, Inc.
Michael Lampe, 484-575-5040
michael@michaellampeconsulting.com

Source: ImmunoGen, Inc.

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