iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech
innovator and biologics contract manufacturing organization, today
announced its financial results for the fiscal year ended June 30,
2020, which included record revenues of over $1.1 million in the
fiscal fourth quarter.
2020 Fiscal Year and
Recent Business
Developments:
CDMO Services
- In July 2019, iBio entered into an
agreement with Lung Biotechnology PBC, a subsidiary of United
Therapeutics Corporation, to produce recombinant human collagen to
be used as a bioink for 3D-bioprinted organs.
- In September 2019, the Company
entered into an initial Statement of Work (“SoW”) with AzarGen
Biotechnologies (Pty.) Ltd. (“AzarGen”), pursuant to which iBio
will manufacture research quantities of a plant-made rituximab for
AzarGen using iBio’s proprietary
FastPharming® System. iBio CDMO
is performing bioanalytical services for the project as well.
- In December 2019, the Company
introduced its Glycaneering Development Service™,
which includes an array of new glycosylation technologies for
engineering high-performance recombinant proteins.
- In December 2019, iBio entered into
a collaboration with EdgePoint AI to deploy EdgePoint’s proprietary
artificial intelligence / blockchain-driven vision system for
pharmaceutical manufacturing, known as TrustPoint Fabric.
- In March 2020, the Company entered
into a second SoW with AzarGen for development and manufacturing
services.
Research & Bioprocessing
- In August 2019, iBio granted
CC-Pharming Ltd. (“CC-Pharming”) a research license to iBio’s
FastPharming System and know-how for the
evaluation of multiple product opportunities.
- In October 2020, iBio entered into
an agreement with Safi Biosolutions, Inc. (“Safi”) to evaluate
iBio’s FastPharming System for the expression of
key proteins to be used in the bioprocessing of Safi blood cell
therapy products. iBio will also work to commercialize cytokines
and growth factors not designated as custom products for use in the
Safi bioprocess as part of its new standard catalog offering of
proteins for research and further manufacturing uses.
Vaccines
- In March 2020, iBio announced the
development of proprietary SARS-CoV-2 Virus-Like Particle
(“VLP”)-based vaccine candidates using its
FastPharming System and filed four related
provisional patent applications with the U.S. Patent and Trademark
Office.
- In March 2020, the Company
announced that immunization studies for its SARS-CoV-2 VLP program
(“IBIO-200”) were proceeding at Texas A&M University System
laboratories.
- In April 2020, the Company signed
agreements with the Infectious Disease Research Institute in
support of iBio’s COVID-19 vaccine development program.
- In June 2020, the Company initiated
preclinical immunization studies for its second SARS-CoV-2 vaccine
candidate, IBIO-201, which combines antigens derived from the
SARS-CoV-2 spike protein fused with iBio’s patented
LicKM™ booster molecule.
- In June 2020, iBio was selected by
IBM Watson Health to receive 18 months of use of the IBM Clinical
Development solution, free-of-charge, to help support clinical
COVID-19 vaccine candidates.
- In August 2020, the Company
announced that IBIO-201 demonstrated an ability to elicit an
anti-SARS-CoV-2 immune response in preclinical studies.
- In September 2020, iBio selected
IBIO-201 as its leading candidate for the prevention of SARS-CoV-2
infection.
Therapeutics
- In August 2019, iBio expanded the
scope of its business venture with CC-Pharming by granting it an
exclusive, royalty-bearing commercial license to iBio’s bio-better
rituximab product candidates for the territory of China.
- In August 2020, iBio entered into
an exclusive worldwide license agreement with Planet Biotechnology
Inc. for the development of a COVID-19 therapeutic candidate based
upon an ACE2-Fc immunoadhesin.
“Fiscal 2020 was a pivotal period for iBio,
marked by the launch of our Glycaneering
Development Service; new collaborations leveraging the
FastPharming System; and most
notably, our transition from a business model focused on CDMO
services to one that also includes the development of our own,
proprietary products,” said Tom Isett, Chairman & CEO of iBio.
“We developed two SARS-CoV-2 vaccine candidates, in-licensed a
COVID-19 therapeutic candidate, and reinvigorated our work on
IBIO-100 for fibrotic diseases.”
2020 Fiscal Year
Corporate
Developments:
- In December 2019, iBio joined the
Advanced Regenerative Manufacturing Institute, which is leading the
Advanced Tissue Biofabrication initiative on behalf of the U.S.
Department of Defense.
- In March 2020, iBio appointed Tom
Isett as its Co-Chairman and CEO, and subsequently, appointed him
Chairman in June 2020.
- In March 2020, the Company joined
the Alliance for Biosecurity.
- In April 2020, iBio expanded its
involvement in the Manufacturing USA® Network, joining the National
Institute for Innovation in Manufacturing Biopharmaceuticals.
Financial Results:
For the fiscal year ended June 30, 2020, iBio
reported revenues of approximately $1.6 million, a decrease of
$380,000 from approximately $2.0 million for the fiscal year ended
June 30, 2019. The decrease is primarily attributable to the timing
of service revenues from CC-Pharming. Revenue earned from
CC-Pharming totaled approximately $1.3 million in 2020, compared
with approximately $1.8 million in 2019. Revenue earned from
third-party customers in 2020 increased approximately 118% to
$371,000 versus $170,000 in 2019. iBio recorded revenues of
over $1.1 million in the fiscal fourth quarter.
Total operating expenses, consisting primarily
of research and development (“R&D”) and general and
administrative (“G&A”) expenses, for the fiscal year ended June
30, 2020 were approximately $15.6 million, compared with
approximately $17.8 million in 2019.
R&D expenses for the 2020 fiscal year were
approximately $3.2 million, compared with approximately $5.5
million in 2019. The decrease in R&D expense of approximately
$1.6 million was primarily related to decreases in third-party
R&D costs of approximately $1.4 million, R&D personnel and
consulting costs of approximately $963,000 and grant income of
$37,000; offset by an increase in R&D project related costs of
$112,000.
G&A expenses for the 2020 fiscal year were
approximately $12.4 million, compared with approximately $12.3
million in the 2019 fiscal year. The increase is primarily
attributable to higher depreciation and amortization expense of
$492,000, professional fees of $508,000, personnel costs of
$380,000 and board of directors’ fees of $168,000; offset by
decreases in repairs and maintenance costs of approximately
$817,000, rent of $409,000, recruiting fees of $131,000, and travel
of $212,000.
Other expense for the 2020 and 2019 fiscal years
was approximately $2.4 million and $1.8 million, respectively. The
increase resulted primarily from higher interest expense related to
the adoption, effective July 1, 2019, of ASU 2016-02, “Leases
(Topic 842)” (“ASU 2016-02”) (“ASC 842”) and other associated
standards using the modified retrospective approach for all leases
entered into before the effective date.
Net loss attributable to iBio stockholders for
the 12 months ended June 30, 2020 was approximately $16.4 million,
or $0.61 per share, compared with a net loss of approximately $17.6
million, or $0.94 per share, in the 2019 fiscal year.
iBio has continued to strengthen its balance
sheet:
- In March, iBio entered into an
agreement to sell common stock to Lincoln Park Capital and raised
net proceeds of approximately $25.2 million prior to concluding the
agreement.
- Through utilization of
at-the-market (“ATM”) offerings during 2020, iBio raised net
proceeds of approximately $42.2 million.
As of June 30, 2020, iBio had cash of
approximately $55.1 million, compared with approximately $4.4
million as of June 30, 2019. Subsequent to fiscal year end, the
Company completed additional ATM offerings, resulting in it having
approximate cash and cash equivalents of $83.1 million on September
30, 2020.
About iBio, Inc.
iBio is a global leader in plant-based biologics
manufacturing. Its FastPharming® System combines
vertical farming, automated hydroponics, and glycan engineering
technologies to rapidly deliver high-quality monoclonal antibodies,
vaccines, bioinks and other proteins. The Company’s subsidiary,
iBio CDMO LLC, provides FastPharming Contract
Development and Manufacturing Services. iBio’s
Glycaneering Development Service™ includes an
array of new glycosylation technologies for engineering
high-performance recombinant proteins. Additionally, iBio is
developing proprietary products, which include IBIO-100 for the
treatment of fibrotic diseases, and vaccines for COVID-19 disease.
For more information, visit www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSCertain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "predict," "forecast," "project," "plan," "intend" or
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding leveraging
the FastPharming® System, manufacturing research quantities of
a plant-made rituximab for AzarGen using iBio’s proprietary
FastPharming System and the Company commercializing cytokines and
growth factors not designated as custom products for use in the
Safi bioprocess as part of its new standard catalog offering of
proteins for research and further manufacturing uses. While the
Company believes these forward-looking statements are reasonable,
undue reliance should not be placed on any such forward-looking
statements, which are based on information available to us on the
date of this release. These forward-looking statements are subject
to various risks and uncertainties, many of which are difficult to
predict that could cause actual results to differ materially from
current expectations and assumptions from those set forth or
implied by any forward-looking statements. Important factors that
could cause actual results to differ materially from current
expectations include, among others, the Company’s ability to obtain
regulatory approvals for commercialization of its product
candidates, including its COVID-19 vaccines, or to comply with
ongoing regulatory requirements, regulatory limitations relating to
its ability to promote or commercialize its product candidates for
specific indications, acceptance of its product candidates in the
marketplace and the successful development, marketing or sale of
products, its ability to maintain its license agreements, the
continued maintenance and growth of its intellectual property
portfolio, its ability to establish and maintain collaborations,
its ability to obtain or maintain the capital or grants necessary
to fund its research and development activities, competition, its
ability to retain its key employees or maintain its NYSE American
listing, and the other risk factors discussed in the Company’s most
recent Annual Report on Form 10-K and the Company’s subsequent
filings with the SEC, including subsequent periodic reports on
Forms 10-Q and 8-K. The information in this release is provided
only as of the date of this release, and we undertake no obligation
to update any forward-looking statements contained in this release
on account of new information, future events, or otherwise, except
as required by law.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580 skilmer@ibioinc.com
iBio,
Inc. |
Condensed
Statement of Operations |
(amounts in
thousands, except per share amounts) |
|
|
|
|
|
Twelve
Months ended June 30, |
|
|
2020 |
|
|
|
2019 |
|
Revenues |
$ |
1,638 |
|
|
$ |
2,018 |
|
|
|
|
|
Operating Expenses |
|
|
|
R&D Expenses |
|
3,213 |
|
|
|
5,474 |
|
SG&A Expenses |
|
12,428 |
|
|
|
12,332 |
|
Total Operating Expenses |
|
15,641 |
|
|
|
17,806 |
|
|
|
|
|
Operating Loss |
|
(14,003 |
) |
|
|
(15,788 |
) |
|
|
|
|
Total Other Income/(Expense) |
|
(2,441 |
) |
|
|
(1,809 |
) |
|
|
|
|
Consolidated Net Loss |
|
(16,444 |
) |
|
|
(17,597 |
) |
Net Loss Attributable to Noncontrolling Interest |
|
5 |
|
|
|
4 |
|
Deemed Dividends - Series A Preferred and Series B Preferred |
|
(21,560 |
) |
|
|
- |
|
Preferred Stock Dividends |
|
(261 |
) |
|
|
(260 |
) |
Net
Loss Available to iBio, Inc. |
|
(38,260 |
) |
|
|
(17,853 |
) |
|
|
|
|
INCOME/(LOSS) PER COMMON SHARE |
$ |
(0.61 |
) |
|
$ |
(0.94 |
) |
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
|
62,795 |
|
|
|
18,926 |
|
|
|
|
|
iBio,
Inc. |
Condensed
Balance Sheet Data |
(amounts in
thousands) |
|
|
|
|
|
June 30, |
|
June 30, |
|
2020 |
|
2019 |
Assets |
|
|
|
Cash and Cash Equivalents |
$ |
55,112 |
|
$ |
4,421 |
Other Current Assets |
|
6,636 |
|
|
387 |
Property, Plant and Equipment |
|
31,273 |
|
|
24,380 |
Other Noncurrent Assets |
|
1,168 |
|
|
1,398 |
Total Assets |
$ |
94,189 |
|
$ |
30,586 |
|
|
|
|
Liabilities and Equity |
|
|
|
Current Liabilities |
$ |
5,236 |
|
$ |
3,458 |
Noncurrent Liabilities |
|
32,346 |
|
|
24,671 |
Total Stockholders' Equity |
|
56,607 |
|
|
2,457 |
Total Liabilities and Equity |
$ |
94,189 |
|
$ |
30,586 |
|
|
|
|
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