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 September 30, 2013 – the first quarter of the Company’s 2014 fiscal year. ImmunoGen also provided an update on Kadcyla ®, the Company’s wholly owned product candidates, other partner programs and the latest additions to its industry-leading ADC technology portfolio. “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 Daniel Junius, President and CEO. “We believe its lead indication provides a meaningful market opportunity for Kadcyla, with many additional indications in development by Roche.” Mr. Junius continued, “Achievements with our wholly owned clinical-stage product candidates include completion of patient enrollment in our NORTH Phase II trial with IMGN901, which keeps us on track to make next-step decisions for this product candidate by mid-2014. We are making progress with IMGN853 and expect to report disease-specific Phase I data mid next year. In 2014, we also expect to report the first clinical findings with IMGN529 and potentially the first data with our newest clinical-stage compound, our EGFR-targeting IMGN289. These different product candidates reflect many enhancements we have made to our ADC technology portfolio in recent years, and our presentations at the recent AACR-NCI-EORTC conference underscore our ongoing commitment to leadership in the ADC field.” 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, 2013 were 152 million CHF in the US and 4 million CHF ex-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.
- Patient enrollment in the Phase II NORTH trial was completed in late September 2013.
- 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.
- ImmunoGen expects to report the first disease-specific data with IMGN853 in mid-2014.
- Its Investigational New Drug (IND) application is active and the Company expects patient dosing in Phase I testing to begin this quarter.
- ImmunoGen expects to report the first IMGN529 clinical data in 2014 and also to begin its assessment in NHL subtypes in 2014.
- 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.
- SAR566658 is 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, SAR566658 was 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.
- Objective responses and sustained clinical benefit have been reported with ImmunoGen and partner ADCs for many different types of cancers.
- 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.
Revenues for 1Q FY2014 were $17.2 million, compared to $4.1 million for 1Q FY2013. Revenues in the current period include $13.2 million of license and milestone fees, compared to $0.9 million in 1Q FY2013. The FY2014 fees include $7.8 million of amortization of upfront license fees from Lilly that were recognized due to Lilly taking a development and commercialization license in August 2013. They also include a $5.0 million milestone from Roche earned with the approval of Kadcyla in Japan. Revenues in 1Q FY2014 also include $2.1 million of royalty payments received from Roche in September 2013 for sales of Kadcyla during the three-month period ended June 30, 2013, $2.0 million of research and development support fees, compared to $1.4 million in such fees for 1Q FY2013, and negligible clinical materials revenue, compared to $1.8 million for 1Q FY2013. The differences in support fees and clinical material revenue are primarily due to the variable nature in the amount of research and in the number of batches of clinical materials produced and released to partners on a quarter-to-quarter basis.Operating expenses in 1Q FY2014 were $28.6 million, compared to $29.3 million in 1Q FY2013. Operating expenses in 1Q FY2014 include research and development expenses of $22.0 million, compared to $23.7 million in 1Q FY2013. This change is primarily due to the sale of less clinical materials to our partners and thus lower associated expenses and to less cost for third-party production of antibody for use in our own clinical materials, partially offset by increased personnel expenses. Operating expenses also include general and administrative expenses of $6.5 million in 1Q FY2014, compared to $5.6 million in 1Q FY2013. This increase is primarily due to increased personnel expenses, including severance expense related to the departure of the former chief financial officer. ImmunoGen had approximately $174.8 million in cash and cash equivalents as of September 30, 2013, compared with $195.0 million as of June 30, 2013, and had no debt outstanding in either period. Cash used in operations was $23.6 million in the first three months of FY2014, compared with $21.0 million in the same period in FY2013. Capital expenditures were $0.6 million and $1.0 million for the first three months of FY2014 and FY2013, respectively.
Updated Financial Guidance for FY 2014ImmunoGen is updating its financial guidance for FY2014 from that issued in August 2013. ImmunoGen now expects:
- Revenues to be between $71 million and $75 million, increased from the $66 million to $70 million range projected previously;
- Operating expenses to be between $140 million and $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 million and $73 million, reduced from the $74 million to $78 million range projected previously;
- Capital expenditures to between $8 million and $10 million, increased from the $6 million to $8 million range projected previously; and
- To end its fiscal year on June 30, 2014 with cash and cash equivalents of between $119 million and $123 million, increased from the $114 million to $118 million range projected previously.
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,2013||June 30,2013|
|Cash and cash equivalents||$||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||$||213,596|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months EndedSeptember 30,|
|License and milestone fees||$||13,167||$||933|
|Research and development support||1,990||1,377|
|Clinical materials revenue||8||1,781|
|Research and development||22,029||23,700|
|General and administrative||6,526||5,639|
|Total operating expenses||28,555||29,339|
|Loss from operations||(11,337||)||(25,248||)|
|Other income, net||111||56|
|Net loss per common share, basic and diluted||$||(0.13||)||$||(0.30||)|
|Weighted average common shares outstanding, basic and diluted||85,010||83,350|