−Quarterly Conference Call Today at 8:00 am ET−
- Progress with all three wholly owned ImmunoGen compounds in clinical testing - IMGN853, IMGN529, IMGN289; decision made to discontinue IMGN901 development.
- Marked increase in partner activity in latter part of 2013, with multiple data presentations and development events expected in 2014.
- Company expects to use less cash in 2014 fiscal year than previously projected; updates guidance.
"We expect 2014 to be a very active year," commented
Eleven compounds are now in the clinic through ImmunoGen product programs and those of its partners.
- All compounds with ImmunoGen technology that have entered the clinic since the Kadcyla IND continue to advance.
- ImmunoGen expects one or more additional partner compounds to advance into clinical testing in 2014.
Kadcyla (ado-trastuzumab emtansine) - The first marketed product with ImmunoGen's ADC technology, Kadcyla is being developed and commercialized by Roche under an agreement with the Company.
Earlier this week, Roche reported 2013 Kadcyla sales of 222 million
CHF in the US and
12 million CHFex-US (in total, approximately $250 million). Kadcyla was approved and launched in the US in February 2013and in some international markets over the course of 2013. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
November 2013, Kadcyla was approved for marketing in the European Union, the second largest pharmaceutical market globally. As with other international markets, the timing of launches in individual EU countries will vary depending on reimbursement processes.
- Roche has opened the Phase III trial, KAITLIN, to assess Kadcyla for adjuvant use in patients with operable HER2-positive breast cancer. Roche reported in October that it also plans to assess Kadcyla for neoadjuvant use for this cancer and expects to have pathological complete response (pCR) results in late 2015. Roche continues to expect to have results from its MARIANNE trial in late 2014 and from its GATSBY trial in early 2015, and, with positive outcomes, to apply in 2015 for first-line treatment of HER2-positive metastatic breast cancer and second-line treatment of advanced HER2-positive gastric cancer, respectively, with the findings from these trials.
IMGN853 - Wholly owned by ImmunoGen, this novel ADC is a potential new treatment for folate receptor α (FRα)-positive cancers, including many ovarian, endometrial and lung cancers.
- The Company plans to present the data in support of dosing IMGN853 based on adjusted ideal body weight (AIBW) at a scientific conference in 2Q 2014. ImmunoGen also intends to report patient data at a medical conference in mid-2014 showing the impact of AIBW dosing on therapeutic window.
- ImmunoGen expects to begin enrolling patients with platinum-resistant ovarian cancer and those with relapsed/refractory endometrial cancer in 1H 2014 in the first IMGN853 Phase I expansion cohorts and to report the first disease-specific data with the compound in 2H 2014. These patients will receive IMGN853 using the current dosing schedule.
- ImmunoGen will also evaluate IMGN853 administered with a more frequent dosing regimen, to enable the best dosing regimen to be used in further evaluation of the compound.
IMGN529 - This novel ADC is a potential new treatment for CD37-positive B-cell malignancies, including non-Hodgkin lymphoma (NHL), and is wholly owned by ImmunoGen.
- ImmunoGen expects the first IMGN529 clinical data to be reported at a medical conference in mid-2014.
- The Company expects patient dosing in expansion phase cohorts to begin in 2H 2014.
IMGN289 - This EGFR-targeting ADC is a potential new treatment for many lung, head and neck cancers, including EGFR-positive tumors resistant to EGFR inhibition. It is wholly owned by ImmunoGen.
The Company advanced IMGN289 into the clinic in
November 2013. The Company potentially could report initial clinical findings and/or development steps in 2H 2014.
BT-062 - This CD138-targeting ADC is in development by Biotest. ImmunoGen has an opt-in right for its co-development and co-commercialization jointly with Biotest in the US.
Initial findings with BT-062 used in combination with Revlimid®
(lenalidomide) plus dexamethasone ("len/dex") to treat heavily
pretreated multiple myeloma (MM) were reported in an oral presentation
at ASH in
December 2013. The findings included that the combination was well tolerated at the selected dose and that 100% of evaluable patients had a response to treatment of stable disease or better, including all of the len/dex-refractory patients. The expansion part of this Phase I trial is ongoing.
- Patient enrollment is expected to start in early 2014 in a Biotest trial assessing BT-062 for the treatment of bladder cancer and triple-negative breast cancer.
Its first clinical data were reported at ASH in December and selected
for "Best of ASH." When used as a single agent to treat heavily
pretreated MM, 77% of evaluable patients had a response to
SAR650984of stable disease or better. Its maximum tolerated dose was not yet established.
Phase II data reported at ASH showed
SAR3419was well tolerated and demonstrated activity, even among patients with primary refractory disease, when used in combination with Rituxan® (rituximab) to treat diffuse large B-cell lymphoma previously treated with several lines of standard therapies, including Rituxan. Two other SAR3419Phase II trials are ongoing in relapsed/refractory DLBCL and in acute lymphoblastic leukemia.
This follows presentation of encouraging initial clinical findings
with another ADC from the collaboration,
SAR566658, at AACR-NCI-EORTC in October, as previously reported.
Clinical testing of Bayer's BAY 94-9343 and Amgen's AMG 172 and AMG 595 is ongoing, with potential for data disclosures and/or development-related events in 2014.
For the Company's quarter ended
Revenues for 2Q FY2014 were
Operating expenses in 2Q FY2014 were
ImmunoGen had approximately
Updated Financial Guidance for Fiscal Year 2014
ImmunoGen is updating its financial guidance for FY2014 from that issued
Revenues to be between $71 million and
$75 million, unchanged from previous guidance;
Operating expenses to be between
$140 millionand $144 million, unchanged from previous guidance;
Net loss to be between $67 million and
$71 million, unchanged from previous guidance;
Net cash used in operations to be between
$64 millionand $68 million, reduced from the $69 million to $73 millionrange in the previous guidance;
Capital expenditures to be between
$8 millionand $10 million, unchanged from previous guidance; and
To end its fiscal year on
June 30, 2014with cash and cash equivalents of between $124 million and $128 million, increased from the $119 millionto $123 millionrange in the previous guidance.
The changes in projected cash used in operations and ending cash and cash equivalents principally reflect the reductions in cash expenses now anticipated for the year, offset by the non-cash expenses expected to be recorded with the establishment of the collaboration with CytomX entered into earlier this month. The accounting treatment of that transaction, however, is still under review.
"These financial results reflect our business model of developing
anticancer products to make a meaningful difference for patients and
using partnerships as an important - and growing - source of
non-dilutive capital," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla®, Revlimid®, and Rituxan® are
registered trademarks of their respective owners. Probody™ is a
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2014 fiscal year; its cash and marketable securities
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||178,088||$||194,960|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||54,854||72,576|
|Total liabilities and shareholders' equity||$||202,523||$||213,596|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended||Six Months Ended|
|License and milestone fees||$||25,678||$||429||$||38,845||$||1,362|
|Research and development support||1,922||2,036||3,912||3,413|
|Clinical materials revenue||125||147||133||1,928|
|Research and development||20,862||21,656||42,891||45,356|
|General and administrative||5,447||5,464||11,973||11,103|
|Total operating expenses||26,309||27,120||54,864||56,459|
|Income (loss) from operations||3,751||(24,508)||(7,586)||(49,756)|
|Other income, net||62||115||172||171|
|Net income (loss)||$||3,813||$||(24,393)||$||(7,414)||$||(49,585)|
|Net income (loss) per common share, basic and diluted||$||0.04||$||(0.29)||$||(0.09)||$||(0.59)|
|Weighted average common shares outstanding, diluted||87,276||84,147||85,221||83,748|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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