−Quarterly Conference Call Today at 8:00 am ET−
"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
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:
Sales development in the US, a positive CHMP opinion for the
European Union, and approvals and/or launches in additional countries, including approval in Japan.
Roche reported Kadcyla sales year-to-date
September 30, 2013were 152 million CHF in the US and 4 million CHFex-US (in total, approximately $168 million). ImmunoGen receives and recognizes royalties on Kadcyla sales the quarter after the quarter in which Roche records the sales.
Positive results from the TH3RESA trial were presented at the 2013
European Cancer Congress.
- Roche reported its plans to conduct a pivotal trial assessing Kadcyla for neoadjuvant use in early stage HER2-positive breast cancer. It expects to start this trial in 2Q2014 and for the pCR (pathological complete response) data to be available in late 2015.
- Roche continues to expect results from its first-line MARIANNE trial in 2014. It expects to apply in 2015 for marketing approval of Kadcyla for first-line treatment of HER2-positive metastatic breast cancer with MARIANNE data and for treatment of advanced HER2-positive gastric cancer with GATSBY data.
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.
Patient enrollment in the Phase II NORTH trial was completed in late
- ImmunoGen expects to have the data needed to make IMGN901 next-step decisions by mid-2014 and to report data from this trial at one or more medical conferences in 2014.
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.
- ImmunoGen expects to report the first disease-specific data with IMGN853 in mid-2014.
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.
- Its Investigational New Drug (IND) application is active and the Company expects patient dosing in Phase I testing to begin this quarter.
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.
ImmunoGen expects to report the first IMGN529 clinical data in 2014
and also to begin its assessment in
NHLsubtypes in 2014.
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,
Clinical data for three partner compounds —
SAR3419, SAR650984, and BT-062 — have been accepted for presentation at a medical meeting in December 2013.
ImmunoGen expects clinical data for one or more partner compounds to
be reported at the
American Association for Cancer Research(AACR) and American Society of Clinical Oncology (ASCO) annual meetings in April and May/ June 2014, respectively.
- ImmunoGen expects one or more partner IND submissions in 2014.
The first clinical data for
SAR566658is in development for the treatment of CA6-positive cancers, which include certain breast and ovarian cancers.
In the dose-finding portion of this Phase I trial,
SAR566658was found to be generally well tolerated and a recommended dose was established for further clinical testing of the compound. Objective responses and stable disease were reported.
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.
- Objective responses and sustained clinical benefit have been reported with ImmunoGen and partner ADCs for many different types of cancers.
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.
- Multiple engineered linkers have been developed by the Company and introduced into new ADCs, with clinical findings reported.
- ImmunoGen scientists have developed a new class of payload agents, DNA-acting IGNs, to extend the opportunity for ADCs to include cancers not responsive to tubulin-acting agents, those with low levels of antigen expression, and those with multidrug resistance.
For the Company's quarter ended
Revenues for 1Q FY2014 were
Operating expenses in 1Q FY2014 were
ImmunoGen had approximately
Updated Financial Guidance for FY 2014
ImmunoGen is updating its financial guidance for FY2014 from that issued
Revenues to be between $71 million and
$75 million, increased from the $66 millionto $70 million range projected previously;
Operating expenses to be between
$140 millionand $144 million, unchanged from the range projected previously;
Net loss to be between $67 million and
$71 million, reduced from the $72 million to $76 million range projected previously;
Net cash used in operations to be between
$69 millionand $73 million, reduced from the $74 million to $78 millionrange projected previously;
Capital expenditures to between
$8 millionand $10 million, increased from the $6 million to $8 millionrange projected previously; and
To end its fiscal year on
June 30, 2014with cash and cash equivalents of between $119 million and $123 million, increased from the $114 millionto $118 millionrange projected previously.
The changes in projected revenue, net loss, cash used in operations, and
ending cash and cash equivalents principally reflect the milestone
payment earned with approval of Kadcyla in
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla® and Herceptin® are registered trademarks
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2014 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||174,838||$||194,960|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||64,042||72,576|
|Total liabilities and shareholders' equity||$||200,024||$||213,596|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
|License and milestone fees||$||13,167||$||933|
|Research and development support||1,990||1,377|
|Clinical materials revenue||8||1,781|
|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 per common share, basic and diluted
Weighted average common shares outstanding, basic and diluted
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