Mon. Feb 24th, 2020

ImmunoGen Reports Recent Progress and 2019 Financial Results – Yahoo Finance

ImmunoGen Reports Recent Progress and 2019 Financial Results  <font color="#6f6f6f">Yahoo Finance</font>

“Following the results of FORWARD I, we moved decisively to restructure the business to reduce our costs, prioritized our portfolio to focus on our most promising programs, and worked constructively with FDA to define an accelerated path to approval for mirvetuximab,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “With the benefit of these steps, we have emerged from a challenging year with significant momentum driven by the start of our registration program for mirvetuximab in platinum-resistant ovarian cancer and continued progress with our portfolio of early-stage products. In particular, we have enrolled the first patient in the confirmatory MIRASOL Phase 3 trial for mirvetuximab, presented clinical data at ASH in December demonstrating IMGN632’s encouraging anti-tumor activity and favorable tolerability in patients with AML and BPDCN, and, most recently, raised roughly $98 million in a follow-on offering to strengthen our balance sheet.”

Enyedy added, “We enter 2020 with a number of important upcoming milestones to drive value in the business. For mirvetuximab, these include opening our pivotal SORAYA trial in the first quarter, continuing to enroll MIRASOL, initiating an additional combination study in platinum-sensitive disease, and presenting data from our platinum-agnostic and platinum-sensitive combination studies. Building upon the encouraging data we reported in 2019, we will continue to advance IMGN632 in the clinic and look forward to presenting BPDCN and MRD+ monotherapy and AML combination data this year. In addition, we expect the IND for IMGC936, our novel ADAM9-targeting ADC, to be filed during the first half of the year. With these catalysts ahead, we look forward to a productive next twelve months.”

  • Received guidance from the U.S. Food and Drug Administration (FDA) that SORAYA, a new single-arm study in platinum-resistant ovarian cancer, could support accelerated approval for mirvetuximab.
  • Enrolled the first patient in our confirmatory Phase 3 MIRASOL trial.
  • Presented preclinical combination data and updated clinical monotherapy data for IMGN632 with additional patients enrolled in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) expansion cohorts at the American Society of Hematology (ASH) Annual Meeting in December.
  • Continued enrollment for IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
  • Advanced IMGN632 combination therapy studies with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed/refractory unfit AML patients.
  • Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
  • Outlicensed our epithelial cell adhesion molecule (EpCAM)-targeting Probody-drug conjugate to CytomX in exchange for an upfront fee and milestone and royalty payments.
  • Raised $97.6 million in a follow-on offering completed in January.
  • Initiate pivotal SORAYA trial in the first quarter of 2020 and continue enrollment in the confirmatory Phase 3 MIRASOL trial.
  • Open an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin.
  • Present initial data from the Phase 1b FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with Avastin® (bevacizumab) in mid-2020 and updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall of 2020.
  • Continue enrollment with IMGN632 monotherapy in relapsed AML, ALL, BPDCN, and MRD+ AML expansion cohorts and in combinations in AML.
  • Present IMGN632 BPDCN and AML combination and MRD+ monotherapy data at ASH in December.
  • File IND for IMGC936 in the first half of 2020.
  • Transition next generation anti-folate receptor alpha (FRα) ADC, IMGN151, to pre-clinical development in mid-2020.
  • License and milestone fees: License and milestone fees of $34.8 million for the year ended 2019, of which $29.6 million was recorded in the fourth quarter, included $14.5 million in amortization of a $75 million upfront fee previously received under the Company’s collaboration agreement with Jazz, $7.3 million of a $7.5 million fee recognized pursuant to a license agreement executed with CytomX in December 2019, and $12.7 million in partner milestones. Of these amounts noted, $15.2 million of related cash will be received in 2020. License and milestone fees of $15.3 million for 2018 included $13.8 million of recognized upfront fees previously received from partners and $1.5 million in partner milestone payments.
  • Non-cash royalty revenue: Non-cash royalty revenue in the fourth quarter and year ended December 31, 2019 increased to $15.3 million and $47.4 million, respectively, compared to $9.3 million and $32.2 million for the same periods in 2018.
  • Research and development expenses were $26.1 million for the quarter ended December 31, 2019 compared to $43.7 million for the quarter ended December 31, 2018, and $114.5 million for the year ended December 31, 2019 compared to $174.5 million for the year ended December 31, 2018. The decreases in both periods are primarily due to: (i) lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019 and the closing of our manufacturing facility at the end of 2018, including decreases in personnel, facility, and third-party research expenses; (ii) lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year periods; and, (iii) decreased clinical trial expenses for the year ended December 31, 2019 driven by lower activity in the FORWARD I Phase 3 clinical trial; however, clinical trial expenses for the fourth quarter of 2019 increased compared to the fourth quarter of 2018 driven by expenses incurred to initiate the MIRASOL and IMGN632 combination studies.

    General and administrative expenses were flat at $9.8 million for the fourth quarter of 2019 and 2018, and $38.5 million for the year ended December 31, 2019 compared to $36.7 million for the year ended December 31, 2018. The increase year over year is primarily due to a higher allocation of facility-related expenses for excess laboratory and office space, partially offset by lower personnel expenses resulting from the restructuring of the business. Similar variances occurred quarter over quarter, but were further offset by lower stock compensation expense driven largely by stock options forfeited in the fourth quarter of 2019.

    Restructuring charge of $0.5 million and $21.4 million recorded in the fourth quarter and year ended December 31, 2019, respectively, related to the restructuring of the business at the end of the second quarter of 2019, compared to $0.4 million and $3.7 million recorded in the same periods in 2018 related to the decommissioning of the Norwood facility.

    Net income for the fourth quarter of 2019 was $4.8 million, or $0.03 per basic and diluted share, compared to a net loss of $(41.8) million, or $(0.28) per basic and diluted share, for the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $(104.1) million, or $(0.70) per basic and diluted share, compared to a net loss of $(168.8) million, or $(1.21) per basic and diluted share.

    In January 2020, pursuant to a public offering, the Company sold an aggregate of 24,523,750 shares of its common stock, with net proceeds to the Company of $97.6 million, after deducting underwriting discounts and estimated offering expenses.

  • revenues between $60 million and $65 million;
  • operating expenses between $165 million and $170 million; and
  • cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.
  • ImmunoGen expects that its current cash, inclusive of the proceeds generated from the recent public offering and anticipated cash receipts from partners, will fund operations into the second half of 2022.

    IMMUNOGEN, INC.
    SELECTED FINANCIAL INFORMATION
    (in thousands, except per share amounts)
     
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
     

    December 31,
    2019

    December 31,
    2018

    ASSETS
     
    Cash and cash equivalents

    $

    176,225

    $

    262,252

    Other assets

    59,437

    33,129

     
    Total assets

    $

    235,662

    $

    295,381

     
    LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY
     
    Current portion of deferred revenue

    $

    309

    $

    317

    Other current liabilities

    77,101

    70,343

    Long-term portion of deferred revenue

    127,123

    80,485

    Other long-term liabilities

    107,250

    133,264

    Shareholders’ (deficit) equity

    (76,121)

    10,972

     
    Total liabilities and shareholders’ (deficit) equity

    $

    235,662

    $

    295,381

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
     

    Three Months Ended
    December 31,

    Year Ended
    December 31,

    2019

    2018

    2019

    2018

     
    Revenues:
    License and milestone fees

    $

    29,551

    $

    1,747

    $

    34,788

    $

    15,280

    Non-cash royalty revenue

    15,313

    9,281

    47,415

    32,154

    Research and development support

    218

    68

    1,377

    Clinical materials revenue

    2,170

    4,635

     
    Total revenues

    44,864

    13,416

    82,271

    53,446

     
    Expenses:
    Research and development

    26,055

    43,681

    114,522

    174,456

    General and administrative

    9,803

    9,752

    38,489

    36,746

    Restructuring charge

    512

    406

    21,433

    3,693

     
    Total operating expenses

    36,370

    53,839

    174,444

    214,895

     
    Income (loss) from operations

    8,494

    (40,423)

    (92,173)

    (161,449)

     
    Non-cash interest expense on liability related to sale of future royalty & convertible bonds

    (5,354)

    (2,428)

    (16,879)

    (10,631)

    Interest expense on convertible bonds

    (24)

    (25)

    (95)

    (95)

    Other income, net

    1,698

    1,077

    5,014

    3,332

     
    Net income (loss)

    $

    4,814

    $

    (41,799)

    $

    (104,133)

    $

    (168,843)

     
    Basic and diluted net income (loss) per common share

    $

    0.03

    $

    (0.28)

    $

    (0.70)

    $

    (1.21)

     
    Basic and diluted weighted average common shares outstanding

    148,809

    147,287

    148,311

    139,946

     

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