Immunomedics, Inc.,
(NASDAQ:
IMMU) (“Immunomedics” or the “Company”), a leading
biopharmaceutical company in the area of antibody-drug conjugates
(ADC), today reported financial results for the first quarter of
2019. Please refer to the Company’s Quarterly Report on Form 10-Q
for more details on the Company’s financial results.
“We have made meaningful progress in all
business areas during the past three months. Significantly, we have
received clarity from the FDA on the CRL and plan to resubmit the
BLA in early fourth quarter of 2019. In the meantime, our
salesforce is working closely with Janssen Biotech Inc. to
co-promote Balversa, allowing our team to further build on its
extensive experience in the oncology community. To enhance
shareholder value and to continue on our path to becoming a global
biopharmaceutical company, we are partnering with China-based
Everest Medicines to develop and commercialize sacituzumab
govitecan in Greater China, the world’s fastest growing
pharmaceutical market. Finally, we have launched the registrational
Phase 3 TROPICS-02 study in late-line HR+/HER2 metastatic breast
cancer to potentially address a large unmet market,” said Behzad
Aghazadeh, Executive Chairman of Immunomedics.
The randomized global TROPICS-02 study is
expected to enroll approximately 400 patients with hormonal
receptor-positive (HR+)/human epidermal growth factor receptor
2-negative (HER2–) metastatic breast cancer (mBC) who have failed
at least two prior chemotherapy regimens for metastatic disease.
Patients are randomized to receive either sacituzumab govitecan or
physician’s choice of eribulin, capecitabine, gemcitabine or
vinorelbine.
The primary endpoint will be progression-free
survival with overall survival serving as secondary endpoint. The
protocol also allows for an interim analysis of overall response
rate (ORR) and duration of response (DoR), the results of which
could support a potential accelerated approval submission.
Recent Company Highlights
- Phase 2 data with sacituzumab govitecan in metastatic
triple-negative breast cancer (mTNBC) were published in the New
England Journal of Medicine.1
- The Company’s sales force is co-promoting Balversa
(erdafitinib) in the U.S. with Janssen Biotech Inc. until the end
of March 2020. Should sacituzumab govitecan be approved for mTNBC
in the U.S. before that time, Immunomedics is only required to
support Balversa in second position detail.
- The Company entered into an exclusive license agreement with
Everest Medicines, the largest single-asset in-licensing deal for
regional China to-date, to support development, registration, and
commercialization of sacituzumab govitecan for key cancer
indications in Greater China, South Korea and certain Southeast
Asian countries. The Company will receive a $65 million upfront
payment and an additional $60 million based on the FDA approval of
sacituzumab govitecan in mTNBC in the U.S., and has the potential
to receive an additional $710 million, if certain milestones are
achieved.
- The Company met with the FDA to discuss issues raised in the
Complete Response Letter (CRL) it received in January 2019. After
receiving clarity from the regulatory agency, the Company plans to
resubmit its Biologics License Application in early fourth quarter
of 2019 seeking the approval of sacituzumab govitecan for the
treatment of patients with mTNBC who have received two prior
therapies for metastatic disease.
- A registrational Phase 3 TROPICS-02 study of sacituzumab
govitecan was launched in late-line HR+/HER2‒ mBC. This study could
support a potential accelerated approval submission with interim
results of ORR and DoR.
Results for the First Quarter of
2019The Company had no revenues for the three months ended
March 31, 2019, due primarily to the discontinued sale of
LeukoScan® during the quarter ended March 31, 2018 in order for the
Company to focus on its ADC business. Revenues in the comparable
quarter ended March 31, 2018, were approximately $0.5 million.
Total costs and expenses were $79.6 million for
the three months ended March 31, 2019, compared to $38.1 million
for the comparable quarter ended March 31, 2018, due primarily to a
$29.3 million increase in research and development expenses, a $6.7
million increase in general and administrative expenses, and a $5.5
million increase in sales and marketing expenses. Most of these
increases were attributable to activities related to preparations
for the potential approval and commercial launch of sacituzumab
govitecan for patients with at least two prior lines of treatment
for metastatic TNBC in the United States, and to expanded clinical
development of sacituzumab govitecan into other indications.
The Company had no non-cash income or expense
for the three months ending March 31, 2019, compared to a $9.8
million non-cash gain for the comparable quarter ended March 31,
2018, due to a decrease in the fair value of outstanding warrants.
There were no warrants outstanding as of March 31, 2019.
Interest expense was $10.0 million for the three
months ended March 31, 2019, compared to $10.9 million for the
comparable quarter March 31, 2018. The decrease was due primarily
to changes in the fair value of our debt balances as a result of
the agreement with RPI Finance Trust.
Net loss attributable to stockholders was $87.3
million, or $0.46 per share, for the three months ended March 31,
2019, compared to $35.5 million, or $0.21 per share, for the
comparable quarter ended March 31, 2018.
As of March 31, 2019, the Company had $442.7
million in cash, cash equivalents, and marketable securities, which
it believes is adequate to support its clinical development plan
for sacituzumab govitecan; further build its clinical and
manufacturing infrastructure and fund its operations through
2020.
Conference CallThe Company will host a
conference call and live audio webcast today at 8:00 a.m. Eastern
Time to discuss first quarter 2019 financial results and provide a
corporate update. To access the conference call, please dial (877)
303-2523 or (253) 237-1755 using the Conference ID 5357619. The
conference call will be webcast via the Investors page on the
Company’s website at https://immunomedics.com/investors/.
Approximately two hours following the live event, a webcast replay
of the conference call will be available on the Company’s website
for approximately 30 days.
Reference
- https://www.nejm.org/doi/full/10.1056/NEJMoa1814213
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer.
Immunomedics’ corporate objective is to become a fully-integrated
biopharmaceutical company and a leader in the field of
antibody-drug conjugates. For additional information on the
Company, please visit its website at https://immunomedics.com/. The
information on its website does not, however, form a part of this
press release.
Cautionary note regarding forward-looking
statementsThis release, in addition to historical
information, may contain forward-looking statements made pursuant
to the Private Securities Litigation Reform Act of 1995. Such
statements, including statements regarding expectations for the
timing or outcome of our planned resubmission of our BLA for
sacituzumab govitecan for the treatment of patients with metastatic
triple-negative breast cancer (mTNBC) who have received at least
two prior therapies for metastatic disease, and expectations for
the related resubmission, the FDA re-inspection of the Company’s
manufacturing facility where we manufacture the monoclonal antibody
for further manufacture into our antibody-drug-conjugate candidate
sacituzumab govitecan, potential approval and commercial launch of
sacituzumab govitecan for that indication and the Company’s
development of sacituzumab govitecan for additional indications,
clinical trials (including the funding therefor, anticipated
patient enrollment, trial outcomes, timing or associated costs),
regulatory applications and related timelines, including the filing
and approval timelines for BLAs, BLA resubmissions, and BLA
supplements, out-licensing arrangements, forecasts of future
operating results, potential collaborations, capital raising
activities, and the timing for bringing any product candidate to
market, involve significant risks and uncertainties and actual
results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are
not limited to, the Company’s reliance on third-party relationships
and outsourcing arrangements (for example in connection with
manufacturing, logistics and distribution, and sales and marketing)
over which it may not always have full control, including the
failure of third parties on which the Company is dependent to meet
the Company’s business and operational needs for investigational or
commercial products and, or to comply with the Company’s agreements
or laws and regulations that impact the Company’s business; the
Company’s ability to meet pre- or post-approval compliance
obligations; imposition of significant post-approval regulatory
requirements on our product candidates, including a requirement for
a post-approval confirmatory clinical study, or failure to maintain
or obtain full regulatory approval for the Company’s product
candidates, if received, due to a failure to satisfy post-approval
regulatory requirements, such as the submission of sufficient data
from a confirmatory clinical study; the uncertainties inherent in
research and development; safety and efficacy concerns related to
the Company’s products and product candidates; uncertainties in the
rate and degree of market acceptance of products and product
candidates, if approved; inability to create an effective direct
sales and marketing infrastructure or to partner with third parties
that offer such an infrastructure for distribution of the Company’s
product candidates, if approved; inaccuracies in the Company’s
estimates of the size of the potential markets for the Company’s
product candidates or limitations by regulators on the proposed
treatment population for the Company’s products and product
candidates; decisions by regulatory authorities regarding labeling
and other matters that could affect the availability or commercial
potential of the Company’s products and product candidates; the
Company’s dependence on business collaborations or availability of
required financing from capital markets, or other sources on
acceptable terms, if at all, in order to further develop our
products and finance our operations; new product development
(including clinical trials outcome and regulatory
requirements/actions); the risk that we or any of our collaborators
may be unable to secure regulatory approval of and market our drug
candidates; risks associated with litigation to which the Company
is or may become a party, including the cost and potential
reputational damage resulting from such litigation; loss of key
personnel; competitive risks to marketed products; and the
Company’s ability to repay its outstanding indebtedness, if and
when required, as well as the risks discussed in the Company’s
filings with the Securities and Exchange Commission. The Company is
not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor Contact:
Dr. Chau Cheng
(862)
260-3727
ccheng@immunomedics.com
Media Contact:Lauren Wood(862)
260-3631lwood@immunomedics.com
IMMUNOMEDICS, INC. AND SUBSIDIARIES |
|
|
Consolidated Balance Sheets |
|
(in thousands) |
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
ASSETS |
|
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
437,935 |
|
|
$ |
492,860 |
|
|
|
Marketable
securities |
|
4,741 |
|
|
|
4,941 |
|
|
Prepaid
expenses |
|
4,868 |
|
|
|
5,354 |
|
|
Other
current assets |
|
1,313 |
|
|
|
1,348 |
|
|
|
|
|
|
|
448,857 |
|
|
|
504,503 |
|
|
|
|
|
|
|
Property and equipment, net |
|
35,448 |
|
|
|
23,469 |
|
|
Other
long-term assets |
|
269 |
|
|
|
68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
484,574 |
|
|
$ |
528,040 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT) |
|
|
|
|
Accounts
payable and accrued expenses |
$ |
53,926 |
|
|
$ |
31,722 |
|
|
Liability
related to sale of future royalties - current |
|
2,657 |
|
|
|
- |
|
|
Lease
liability - current |
|
298 |
|
|
|
- |
|
|
Convertible
senior notes - net |
|
7,068 |
|
|
|
7,055 |
|
|
|
Liability
related to sale of future royalties - non-current |
|
228,600 |
|
|
|
221,295 |
|
|
|
Other
long-term liabilities |
|
10,221 |
|
|
|
2,119 |
|
|
|
Stockholders' equity (deficit) |
|
181,804 |
|
|
|
265,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
484,574 |
|
|
$ |
528,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Operations |
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
|
March 31, |
|
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Product
sales |
$ |
- |
|
|
$ |
450 |
|
|
License fee
and other revenues |
|
- |
|
|
|
15 |
|
|
Research
& development |
|
|
- |
|
|
|
17 |
|
|
|
Total
Revenues |
$ |
- |
|
|
$ |
482 |
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses: |
|
|
|
|
|
|
Costs of
goods sold |
|
- |
|
|
|
47 |
|
|
Research
and development |
|
58,172 |
|
|
|
28,843 |
|
|
|
Sales and
marketing |
|
7,881 |
|
|
|
2,366 |
|
|
|
General and
administrative |
|
|
13,595 |
|
|
|
6,854 |
|
|
|
Costs and
Expenses |
|
|
79,648 |
|
|
|
38,110 |
|
|
|
Operating
Loss |
|
(79,648 |
) |
|
|
(37,628 |
) |
|
|
Changes in
fair market value of warrant liabilities |
|
- |
|
|
|
9,835 |
|
|
|
Interest
expense |
|
(9,959 |
) |
|
|
(10,900 |
) |
|
|
Interest
and other income |
|
|
|
2,203 |
|
|
|
1,130 |
|
|
|
Insurance
reimbursement |
|
- |
|
|
|
1,930 |
|
|
|
Foreign
currency transaction gain, net |
|
|
- |
|
|
|
75 |
|
|
|
Loss
before income tax |
|
(87,404 |
) |
|
|
(35,558 |
) |
|
|
Income tax
(expense) benefit |
|
|
- |
|
|
|
- |
|
|
|
Net
Loss |
|
(87,404 |
) |
|
|
(35,558 |
) |
|
|
Less Net
Loss attributable to noncontrolling interest |
|
|
(67 |
) |
|
|
(12 |
) |
|
|
Net Loss
attributable to Immunomedics, Inc. stockholders |
|
$ |
(87,337 |
) |
|
$ |
(35,546 |
) |
|
|
|
|
|
|
|
|
|
|
Net Loss
per Common Share attributable to Immunomedics, Inc. stockholders
(basic and diluted): |
|
$ |
(0.46 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
Weighted
average number of common shares |
|
|
|
|
|
outstanding (basic and
diluted): |
|
|
191,052 |
|
|
|
166,054 |
|
|
|
|
|
|
|
|
|
|
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Mar 2024 to Apr 2024
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Apr 2023 to Apr 2024