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Subjects: EARNINGS, Conference, Product/Service, Trade Show, Conference Call, Webcast

ImmunoGen Reports Recent Progress and First Quarter 2022 Financial Results


ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2022.

"Following the presentation of the results from our positive pivotal SORAYA trial at SGO, we were pleased to submit the BLA to support the accelerated approval of mirvetuximab monotherapy in FR?-high platinum-resistant ovarian cancer. We requested Priority Review for the BLA and look forward to acceptance towards the end of May and a PDUFA date on the application later this year," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "In preparation for potential commercialization, we have significantly ramped our launch readiness activities, with a focus on increasing mirvetuximab and FR? awareness among prescribers."

Enyedy continued, "The broader mirvetuximab program is also advancing nicely, with accrual accelerating in MIRASOL following the release of the SORAYA results in late November, enrollment continuing in PICCOLO, and initiation of our GLORIOSA and Trial 0420 combination studies anticipated by mid-year. Based upon a reforecast generated in conjunction with the recent pre-specified interim futility analysis for MIRASOL, we now expect to reach the requisite number of PFS events in the fourth quarter and will report top-line data from MIRASOL in early 2023. Turning to our second pivotal program, pivekimab, with the recommended phase 2 dose for the triplet in combination with azacitidine and venetoclax determined, we have moved forward with expansion cohorts in both frontline and relapsed AML patients and are on track to report preliminary efficacy data from our pivotal CADENZA study in BPDCN before year-end. Regarding our earlier-stage programs, dose-escalation continues in the Phase 1 trial of IMGC936 in multiple solid tumors and the activities to generate the CMC information needed for our IND for IMGN151 are on track. With a strong start and intense focus on execution, we are well positioned to deliver on our near-term objectives and transform ImmunoGen into a fully-integrated oncology company this year."

RECENT PROGRESS

ANTICIPATED UPCOMING EVENTS

FINANCIAL RESULTS

Total revenues were $38.1 million for the quarter ended March 31, 2022 compared to $15.7 million for the quarter ended March 31, 2021. The increase was driven by the recognition of $21.6 million of fees previously received and deferred pursuant to the Company's collaboration agreement with Huadong Medicine and the recognition of $9.2 million of a $13.0 million upfront payment received pursuant to the Company's license agreement with Lilly in the first quarter of 2022. Partially offsetting these increases, non-cash royalty revenue decreased $9.1 million due to the completion of the first tranche of payments under the 2015 KADCYLA® royalty agreement in the second quarter of 2021.

Operating expenses for the quarter ended March 31, 2022 were $60.9 million, compared with $44.6 million for the same quarter in 2021. Research and development expenses rose to $44.3 million for the quarter ended March 31, 2022 compared to $34.4 million for the quarter ended March 31, 2021, driven by increases in personnel and temporary staffing costs, regulatory filing fees, third-party service fees, and external manufacturing costs in support of commercial readiness. Selling, general and administrative expenses increased to $16.6 million for the quarter ended March 31, 2022 compared to $10.2 million for the quarter ended March 31, 2021, due primarily to building commercial capabilities, including the hiring of personnel, in anticipation of a potential US launch of mirvetuximab in the second half of 2022.

Net loss for the first quarter of 2022 was $24.1 million, or $0.10 per basic and diluted share, compared to a net loss of $34.1 million, or $0.17 per basic and diluted share, for the first quarter of 2021. Weighted average shares outstanding increased to 253.3 million for the 2022 period from 198.8 million in the prior year.

ImmunoGen had $437.7 million in cash and cash equivalents as of March 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $41.4 million for the first three months of 2022, compared with cash used in operations of $44.6 million for the same period in 2021, with the current period benefitting from a $13.0 million upfront license payment received from Lilly. Capital expenditures were $0.3 million and $0.9 million for the first three months of 2022 and 2021, respectively.

FINANCIAL GUIDANCE

ImmunoGen's financial guidance for 2022 remains unchanged; the Company continues to expect:

Given the range in timing for potential approval, revenue guidance does not yet include potential product sales from mirvetuximab.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 5444669. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT IMMUNOGEN

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOWtm.

Learn more about who we are, what we do, and how we do it at www.immunogen.com.

Avastin®, Vidaza®, Venclexta®, and Kadcyla® are registered trademarks of their respective owners.

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These statements include, but are not limited to, ImmunoGen's expectations related to: the Company's revenues and operating expenses for 2022 and its cash and cash equivalents as of December 31, 2022; the Company's anticipated cash runway; the occurrence, timing, and outcome of potential preclinical, clinical, and regulatory events related to, and the potential benefits of, the Company's product candidates, including, but not limited to: the accelerated approval of the Company's BLA to the FDA for mirvetuximab, the commercial launch of mirvetuximab, the initiation of Trial 0420, the GLORIOSA Phase 3 trial, the expansion cohort combining pivekimab, azacitidine, and venetoclax in frontline AML, the completion of the dose-escalation Phase 1 study evaluating IMGC936 and the dosing of patients in a Phase 1 study for IMGN151; the timing and presentation of preclinical and clinical data on the Company's product candidates, including additional safety and efficacy data from SORAYA, top-line data for the MIRASOL study, top-line data from the CADENZA study, initial data from the frontline and relapsed AML expansion cohorts; and initial data from the Phase 1 dose-escalation study evaluating IMGC936; and the Company's business and product development strategies. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company's preclinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the Company's anticipated interactions with regulatory authorities, including that the FDA may determine that our BLA for mirvetuximab is not complete and acceptable for filing or does not meet the conditions for accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen's industry and business; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

 
IMMUNOGEN, INC.
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
 
March 31, December 31,

2022

2021

ASSETS
 
Cash and cash equivalents $

437,661

 

$

478,750

 

Other assets

44,048

 

47,015

 

 
Total assets $

481,709

 

$

525,765

 

 
LIABILITIES AND SHAREHOLDERS' EQUITY
 
Current portion of deferred revenue $

23,417

 

$

44,351

 

Other current liabilities

60,701

 

56,594

 

Long-term portion of deferred revenue

46,694

 

47,717

 

Other long-term liabilities

44,429

 

51,517

 

Shareholders' equity

306,468

 

325,586

 

 
Total liabilities and shareholders' equity $

481,709

 

$

525,765

 

 
 
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
March 31,

2022

2021

 
Revenues:
License and milestone fees $

30,892

 

$

157

 

Non-cash royalty revenue

6,428

 

15,545

 

Research and development support

758

 

4

 

 
Total revenues

38,078

 

15,706

 

 
Expenses:
Research and development

44,282

 

34,413

 

Selling, general and administrative

16,648

 

10,209

 

 
Total operating expenses

60,930

 

44,622

 

 
Loss from operations

(22,852

)

(28,916

)

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

(1,249

)

(4,644

)

Interest expense on convertible bonds

-

 

(24

)

Other loss, net

(44

)

(467

)

 
Net loss $

(24,145

)

$

(34,051

)

 
Basic and diluted net loss per common share $

(0.10

)

$

(0.17

)

 
Basic and diluted weighted average common shares outstanding

253,263

 

198,835

 

 


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News published on 6 may 2022 at 06:35 and distributed by: