BeiGene, Ltd. (NASDAQ:BGNE) a clinical-stage biopharmaceutical
company developing innovative molecularly-targeted and
immuno-oncology drugs for the treatment of cancer, today reported
business highlights and financial results for the fourth quarter
and full year of 2016.
“2016 was a year of substantial progress and growth
for our company,” said John V. Oyler, Founder, Chief Executive
Officer, and Chairman of BeiGene, “We significantly advanced our
portfolio of four clinical-stage assets, and our clinical trials
together have enrolled nearly 1,000 patients. We have initiated
three global combination studies, and, in China, all four of our
compounds have entered the clinic. We recently reached a
significant milestone—the initiation of pivotal programs with our
BTK inhibitor BGB-3111 both globally and in China.”
“In 2016, we made key executive hires and
significantly expanded our global clinical development
capabilities. We strengthened our balance sheet with a $199 million
follow-on public offering in November. We recently entered into a
joint venture agreement with the Guangzhou Development District
that provides more than RMB2 billion ($300 million) for building a
commercial biologics manufacturing facility as well as for funding
research and development of our biologic drug candidates in China.
In 2017, we look forward to sharing updated data from multiple
clinical programs, including more mature data from our monotherapy
studies and initial data from our combination studies, and
initiating additional registrational trials of our portfolio
compounds,” commented Mr. Oyler.
2016 and Recent Business
Highlights
Clinical Programs:
In total, over 980 patients were enrolled as of
March 20, 2017 across four clinical programs, including combination
trials.
BGB-3111, a potent and highly
selective small molecule inhibitor of Bruton’s tyrosine kinase
(BTK)
- Initiated a global Phase III trial of BGB-3111 compared with
ibrutinib in patients with Waldenström’s Macroglobulinemia
(WM).
- Initiated our pivotal clinical program with BGB-3111 in China,
including a study in patients with relapsed / refractory Mantle
Cell Lymphoma (MCL) and a study in patients with relapsed /
refractory Chronic Lymphocytic Leukemia / Small Lymphocytic
Lymphoma (CLL / SLL).
- Presented updated clinical data on BGB-3111 in patients with
CLL / SLL and WM at the 2016 American Society of Hematology (ASH)
Annual Meeting.
- Continued enrollment in the multi-indication dose-expansion
phase of the BGB-3111 Phase I monotherapy trial
in Australia, New Zealand, the United States,
and South Korea.
- Continued enrollment in the Phase I trial of BGB-3111 as a
monotherapy in China.
- Continued enrollment in the dose-expansion phase of the global
combination study with obinutuzumab, an anti-CD20 antibody.
- Continued enrollment in the combination trial of BGB-3111 with
BGB-A317 in Australia in patients with B-cell
malignancies.
BGB-A317, an investigational
humanized monoclonal antibody against the immune
checkpoint receptor PD-1
- Initiated a Phase I study of BGB-A317 in Chinese patients with
advanced solid tumors.
- Presented updated clinical data on BGB-A317 in patients with
advanced solid tumors at the Society for Immunotherapy of Cancer
31st Annual Meeting.
- Continued enrollment in the multi-indication dose-expansion
phase of the BGB-A317 Phase I monotherapy trial in Australia, New
Zealand, the United States, South Korea, and Taiwan.
- Continued enrollment in the global combination trial of
BGB-A317 and BGB-290 in patients with advanced solid tumors.
- Continued enrollment in the combination trial of BGB-A317 with
BGB-3111 in patients with B-cell malignancies.
BGB-290, a potent and highly
selective PARP inhibitor
- Initiated a Phase I study of BGB-290 in Chinese patients with
advanced solid tumors.
- Continued enrollment in the dose-expansion phase of the BGB-290
Phase I monotherapy trial in Australia.
- Continued enrollment in the global combination trial of BGB-290
and BGB-A317 in patients with advanced solid tumors.
BGB-283, a novel RAF dimer
inhibitor that targets both BRAF- and RAS-mutated cancers
- Continued following patients in the dose-expansion phase of the
Phase I trial of BGB-283 in patients with solid tumors with BRAF
mutations and/or aberrations in the MAPK pathway in Australia
and New Zealand.
- Regained ex-China rights to develop, manufacture and
commercialize BGB-283 after Merck KGaA, Darmstadt Germany did not
exercise the Continuation Option in its former exclusive license to
commercialize and manufacture the molecule outside of China.
Corporate Development:
- Established a definitive agreement to enter into a joint
venture with the Guangzhou Development District and its affiliate,
Guangzhou GET Technology Development Co., Ltd., for the
establishment of a commercial biologics manufacturing facility in
Guangzhou, Guangdong Province, China. Expected direct investments
total RMB 2.2 billion ($330 million) funding includes support for
the research and development of our biologic drug candidates in
China.
Expected Upcoming Milestones
BGB-3111 (BTK Inhibitor)
- Present updated Phase I monotherapy data in 2017.
- Present data from the Phase I combination studies of BGB-3111
with obinutuzumab and BGB-3111 with BGB-A317 in 2017.
BGB-A317 (PD-1 Antibody)
- Present data from the Phase I combination studies of BGB-A317
with BGB-290 and BGB-A317 with BGB-3111 in 2017.
- Present data from the dose-expansion phase of the ongoing Phase
I trial in 2017.
BGB-290 (PARP Inhibitor)
- Present updated Phase I monotherapy data in 2017.
- Present data from the Phase I combination study with BGB-A317
in 2017.
BGB-283 (RAF Dimer Inhibitor)
- Present dose-expansion data from the ongoing Phase I study in
an oral presentation during a Clinical Trials Plenary Session at
the 2017 American Association for Cancer Research Annual Meeting on
April 2, 2017.
Fourth Quarter and Full Year 2016 Financial
Results
Cash, Cash
Equivalents, and Short-term Investments were $368.17
million as of December 31, 2016, compared to $100.49
million as of December 31, 2015. The increase reflects
proceeds received from our initial public offering (IPO) in the
first quarter of 2016 and a follow-on public offering in the fourth
quarter of 2016 partially offset by cash used in operating
activities for the twelve months ended December 31, 2016.
The cash used in operations for the quarter and
year ended December 31, 2016 was $26.14
million and $89.51 million, respectively, as compared
to $16.76 million and $39.84 million, respectively,
for the same periods in 2015. The increase was primarily
attributable to higher operating expense. Capital expenditure for
the quarter and year ended December 31,
2016 was $8.06 million and $23.50 million,
respectively, as compared to $3.42 million and $5.31
million, respectively, for the same periods in 2015. The increase
was primarily attributable to the construction of the manufacturing
facility in Suzhou.
In February 2016, BeiGene completed its IPO of
7,590,000 American Depositary Shares (“ADSs”) at $24.00 per ADS on
the NASDAQ stock exchange. Net proceeds were $166.20 million after
underwriting discounts and offering expenses. In addition, Merck
Sharp & Dohme Research GmBH, an affiliate of Merck & Co.,
elected to exchange a senior promissory note of $14.69 million
including principle and accrued interest for BeiGene’s ordinary
shares at the per share IPO price.
In November 2016, BeiGene completed a follow-on
public offering of 6,250,000 ADSs plus an over-allotment of 850,000
ADSs, including 6,631,250 ADSs offered by BeiGene and 468,750 ADSs
offered by certain selling shareholders, at a price of $32.00 per
ADS. Net proceeds were $198.63 million after underwriting discounts
and offering expenses.
Revenue for the three and
twelve months ended December 31, 2016 was nil and $1.07
million, respectively, compared to $4.68 million and
$8.82 million in the same periods in 2015. Changes in revenue are
primarily attributable to a decrease of revenue recognized for
BGB-283 and revenue that was no longer being recognized for BGB-290
in 2016 after we repurchased the ex-PRC rights from Merck KGaA,
Darmstadt Germany in October 2015.
Research & Development
(R&D) Expenses for the three and twelve
months ended December 31, 2016 were $28.93 million
and $98.03 million, respectively, compared to $28.10 million and
$58.25 million in the same periods in 2015. The increase in
R&D expenses was primarily attributable to increased spending
on clinical activities for BGB-3111, BGB-A317, and BGB-283, due to
expansion of ongoing clinical programs, start-up activities for
registration trials and increased employee compensation as a result
of increased headcount to support growing clinical studies. In
addition, R&D-associated stock option expenses were $2.90
million and $8.08 million for the three and twelve months
ended December 31, 2016, respectively, compared to $1.83
million and $9.59 million for the same periods in
2015.
General & Administrative
(G&A) Expenses for the three and twelve
months ended December 31, 2016 were $8.34 million
and $20.10 million, respectively, compared to $2.95 million and
$7.31 million in the same periods in 2015. The increase in
G&A expenses was primarily attributable to increased employee
compensation including share-based compensation as a result of
increased headcount and higher professional service fees to support
growing operations. In addition, G&A-associated stock option
expenses were $1.05 million and $2.55 million for
the three and twelve months ended December 31, 2016,
respectively, compared to $0.34 million and $0.62
million for the same periods in 2015.
Net Loss for the three
and twelve months ended December 31,
2016 were $37.60 million and $119.22 million,
respectively, compared to $27.25 million and $57.10 million in the
same periods in 2015.
Financial Summary:
Select Consolidated
Balance
Sheet Data (U.S. GAAP) |
(Amounts in thousands of U.S. Dollars) |
(Audited) |
|
|
December 31,
2016 |
|
|
|
December 31, 2015 |
|
Cash, cash equivalents, and short‑term investments |
$ |
|
368,174 |
|
|
$ |
100,486 |
|
Prepaid expenses and other current assets |
|
|
6,225 |
|
|
|
5,783 |
|
Property and equipment, net |
|
|
25,977 |
|
|
|
6,612 |
|
Total assets |
|
|
405,813 |
|
|
|
116,764 |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
11,957 |
|
|
|
8,980 |
|
Senior promissory note |
|
|
— |
|
|
|
14,598 |
|
Long-term bank loan |
|
|
17,284 |
|
|
|
6,188 |
|
Total shareholders’ equity (deficit) |
$ |
|
352,907 |
|
|
$ |
(101,765 |
) |
|
Consolidated
Statements of Operations
(U.S. GAAP) |
|
(Amounts in thousands of U.S. Dollars, except for
number of ADSs and per ADS data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Collaboration revenue |
|
$ |
- |
|
$ |
4,677 |
|
$ |
1,070 |
|
$ |
8,816 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(28,933 |
) |
|
(28,103 |
) |
|
(98,033 |
) |
|
(58,250 |
) |
|
General and administrative |
|
|
(8,337 |
) |
|
(2,950 |
) |
|
(20,097 |
) |
|
(7,311 |
) |
|
Total operating expenses |
|
|
(37,270 |
) |
|
(31,053 |
) |
|
(118,130 |
) |
|
(65,561 |
) |
|
Loss from operations |
|
|
(37,270 |
) |
|
(26,376 |
) |
|
(117,060 |
) |
|
(56,745 |
) |
|
Interest income, net |
|
|
47 |
|
|
113 |
|
|
383 |
|
|
559 |
|
|
Other income (expense), net |
|
|
(627 |
) |
|
(987 |
) |
|
(2,486 |
) |
|
(916 |
) |
|
Loss before income tax expense |
|
|
(37,850 |
) |
|
(27,250 |
) |
|
(119,163 |
) |
|
(57,102 |
) |
|
Income tax expense |
|
|
252 |
|
|
- |
|
|
(54 |
) |
|
- |
|
|
Net loss |
|
$ |
(37,598 |
) |
$ |
(27,250 |
) |
$ |
(119,217 |
) |
$ |
(57,102 |
) |
|
Net loss per ADS, basic and diluted |
|
$ |
(1.05 |
) |
$ |
(3.05 |
) |
$ |
(3.84 |
) |
$ |
(6.71 |
) |
|
Weighted-average number of ADS used in netloss per ADS
calculation - basic and diluted |
|
|
35,663,284 |
|
|
8,936,469 |
|
|
31,047,650 |
|
|
8,507,482 |
|
Consolidated
Statements of
Comprehensive Loss (U.S. GAAP) |
(Amounts in thousands of U.S. Dollars)
(unaudited) |
|
|
|
|
|
|
|
Three Months EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Net
loss |
|
$ |
(37,598 |
) |
$ |
(27,250 |
) |
$ |
(119,217 |
) |
$ |
(57,102 |
) |
Other
comprehensive loss, net of tax of nil: |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Foreign currency translation adjustments |
|
|
(232 |
) |
|
(240 |
) |
|
(245 |
) |
|
(749 |
) |
Unrealized holding gain (loss) |
|
|
251 |
|
|
(436 |
) |
|
1,108 |
|
|
(1,160 |
) |
Comprehensive loss |
|
$ |
(37,579 |
) |
$ |
(27,926 |
) |
$ |
(118,354 |
) |
$ |
(59,011 |
) |
About BeiGene
BeiGene is a global, clinical-stage, research-based
biotechnology company focused on molecularly targeted and
immuno-oncology cancer therapeutics. With a team of over 300
scientists, clinicians and staff in mainland China, the United
States, Australia and Taiwan, BeiGene is advancing a pipeline
consisting of novel oral small molecules and monoclonal antibodies
for cancer. BeiGene is working to create combination solutions
aimed to have both a meaningful and lasting impact on cancer
patients.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
BeiGene’s financial condition; results of operations and business
outlook; the sufficiency of its cash, cash equivalents and
short-term investments; the joint venture with the Guangzhou
Development District and any related anticipated funding for
building a manufacturing facility and clinical development;
momentum of its product pipeline as well as the advancement of, and
anticipated clinical development and regulatory milestones and
plans related to BeiGene’s drug candidates and clinical trials,
including commencing registration and combination trials and
providing data readouts and updates for its clinical candidates.
Actual results may differ materially from those indicated in the
forward-looking statements as a result of various important
factors, including BeiGene's ability to demonstrate the efficacy
and safety of its drug candidates; the clinical results for its
drug candidates, which may not support further development; actions
of regulatory agencies, which may affect the initiation, timing and
progress of clinical trials; BeiGene's ability to achieve market
acceptance in the medical community necessary for commercial
success; BeiGene's ability to obtain and maintain protection of
intellectual property for its technology and drugs; BeiGene's
reliance on third parties to conduct preclinical studies and
clinical trials; BeiGene’s limited operating history and BeiGene's
ability to obtain additional funding for operations and to complete
the development and commercialization of its drug candidates, as
well as those risks more fully discussed in the section entitled
“Risk Factors” in BeiGene’s most recent quarterly report on Form
10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in BeiGene's subsequent filings with the
U.S. Securities and Exchange Commission. All information in
this press release is as of the date of this press release, and
BeiGene undertakes no duty to update such information unless
required by law.
Investor/Media Contact
Lucy Li, Ph.D.
+1 781-801-1800
ir@beigene.com
media@beigene.com
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