- Initial findings reported at the annual meeting of the American Association of Cancer Research (AACR) earlier this month showed the change made in dose calculation – from use of total body weight (TBW) to adjusted ideal body weight (AIBW) – appears to have achieved its objective: none of the six patients treated with IMGN853 at 5 mg/kg AIBW had ocular toxicity compared with four of ten using TBW. Evidence of activity has been seen with IMGN853 at doses of 3.3 mg/kg (TBW) and above, as previously reported.
- Additional IMGN853 clinical data are to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).
- The Company expects to establish the maximum tolerated dose of IMGN853 with the current once every 3 weeks dosing schedule this quarter and to begin assessing IMGN853 specifically in patients with platinum-resistant ovarian cancer or relapsed endometrial cancer. The first disease-specific data are expected to be reported later this year.
- IMGN853 also is being assessed using a modified weekly dosing schedule, to enable the best schedule to be used as it advances.
- The first clinical findings with IMGN529 are scheduled for presentation at ASCO.
- The Company reported preclinical data at AACR on the activity of IMGN289 against tyrosine kinase inhibitor (TKI)-resistant EGFR-positive cancers.
- Dose-escalation is ongoing in the IMGN289 Phase I clinical trial, with updates – initial data and/or development events – expected in the second half of 2014.
- Sales – Roche reported global Kadcyla sales of 102 million CHF (approximately $115 million) for the first quarter of 2014 (January-March, 2014). Launch of Kadcyla has begun in some countries in the EU and is ongoing in the US; launch in Japan began last week. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
- First-line for HER2-positive metastatic breast cancer – Roche expects results from its MARIANNE Phase III trial to be reported in the second half of 2014, and – with positive results – to submit in 2015 for regulatory approval.
- Advanced HER2-positive gastric cancer – Roche is evaluating Kadcyla for second-line use in this disease in its GATSBY trial. Regulatory submission – with positive results – is expected in 2015.
- Early stage HER2-positive breast cancer – Roche has three Phase III trials with Kadcyla: KAITLIN, for adjuvant use, which is underway; KATHERINE, for residual invasive disease, which is underway; and KRISTINE, for neo-adjuvant use, which is expected to start this quarter.
- The first clinical data with Amgen’s AMG 595 in glioblastoma were reported at AACR, with evidence of activity seen at doses that were well tolerated.
- With the presentation of the AMG 595 data at AACR, encouraging initial clinical findings have now been reported for six partner compounds in addition to Kadcyla: Amgen’s AMG 595, Bayer HealthCare’s BAY 94-9343 (anetumab ravtansine), Biotest’s BT-062 (indatuximab ravtansine), Sanofi’s SAR3419 (coltuximab ravtansine), SAR566658, and SAR650984.
- Patient dosing has begun in a clinical trial assessing CD138-targeting BT-062 for the treatment of triple negative metastatic breast cancer and metastatic urinary bladder cancer. BT-062 also is in clinical testing for the treatment of multiple myeloma. ImmunoGen has a BT-062 opt-in right for co-development and co-commercialization jointly with Biotest in the US.
- ImmunoGen expects one or more partner IND submissions in 2014, plus additional clinical data presentations.
Revenues for 3Q FY2014 were $6.9 million, compared to $25.0 million for 3Q FY2013. Revenues in the current period include $0.3 million of license and milestone fees, compared to $22.0 million in 3Q FY2013. The prior year fees include $11.1 million of amortization of an upfront license fee received from Novartis in FY2011 that was recognized in 3Q FY2013 with Novartis taking a development and commercialization license in that quarter as well as a $10.5 million milestone payment from Roche earned in 3Q FY2013 with the approval of Kadcyla in the US.Revenues in 3Q FY2014 also include $2.6 million of royalty payments received from Roche in March 2014 for sales of Kadcyla during the three-month period ended December 31, 2013; the Company had no royalty revenue in 3Q FY2013. Additionally, revenues in 3Q FY2014 include $1.9 million of research and development support fees, compared to $2.3 million in such fees for 3Q FY2013, and $2.1 million of clinical materials revenue, compared to $0.7 million for 3Q FY2013. The amount of research and the number of batches of clinical materials produced and released to partners varies on a quarter-to-quarter basis. Operating expenses in 3Q FY2014 were $44.3 million, compared to $26.3 million in 3Q FY2013. Operating expenses in 3Q FY2014 include research and development expenses of $38.3 million, compared to $21.3 million in 3Q FY2013. In 3Q 2014, the Company recorded a $12.8 million non-cash charge to research and development expense for technology rights obtained under the collaboration agreement executed with CytomX in January 2014. Also driving the change from the prior period are increased personnel expenses and increased costs associated with manufacturing clinical materials on behalf of our partners. Operating expenses also include general and administrative expenses of $6.0 million in 3Q FY2014, compared to $5.0 million in 3Q FY2013. This increase is primarily due to increased personnel expenses and patent expenses. ImmunoGen had approximately $164.1 million in cash and cash equivalents as of March 31, 2014, compared with $195.0 million as of June 30, 2013, and had no debt outstanding in either period. Cash used in operations was $34.7 million in the first nine months of FY2014, compared with $48.7 million in the same period in FY2013. Capital expenditures were $4.7 million and $2.4 million for the first nine months of FY2014 and FY2013, respectively.
Updated Financial Guidance for Fiscal Year 2014ImmunoGen is updating its financial guidance for FY2014 from that issued in January 2014. ImmunoGen now expects:
- Revenues to be between $60 million and $64 million, compared with previous guidance of between $71 million and $75 million;
- Operating expenses to be between $133 million and $137 million, compared with previous guidance of between $140 million and $144 million;
- Net loss to be between $71 million and $75 million, compared with previous guidance of between $67 million and $71 million;
- Net cash used in operations to be between $56 million and $60 million, compared with previous guidance of between $64 million and $68 million;
- Capital expenditures to between $8 million and $10 million, unchanged from previous guidance; and
- To end its fiscal year on June 30, 2014 with cash and cash equivalents of between $134 million and $138 million, compared with previous guidance of between $124 million and $128 million.
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||June 30,|
|Cash and cash equivalents||$||164,076||$||194,960|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||67,563||72,576|
|Total liabilities and shareholders' equity||$||186,694||$||213,596|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|March 31,||March 31,|
|License and milestone fees||$||305||$||22,010||$||39,150||$||23,372|
|Research and development support||1,948||2,257||5,860||5,670|
|Clinical materials revenue||2,064||734||2,197||2,662|
|Research and development||38,280||21,318||81,171||66,674|
|General and administrative||6,040||4,995||18,013||16,098|
|Total operating expenses||44,320||26,313||99,184||82,772|
|Loss from operations||(37,445)||(1,312)||(45,031)||(51,068)|
|Other (expense) income, net||(7)||(39)||166||132|
|Net loss per common share, basic and diluted||$||(0.44)||$||(0.02)||$||(0.53)||$||(0.61)|
|Weighted average common shares outstanding, basic and diluted||85,684||84,279||85,375||83,923|