Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today reported business
highlights and financial results for the fourth quarter and year
ended December 31, 2019. In addition, Agios highlighted key 2020
corporate milestones and data presentations for its clinical
development programs.
“On the heels of a busy and productive 2019, I’m more confident
than ever in the strength of our team and our ability to make a
meaningful impact on the lives of patients through great science, a
deep pipeline and differentiated therapies,” said Jackie Fouse,
Ph.D., chief executive officer at Agios. “In 2020, our clinical
development team is focused on advancing our Phase 3 PK deficiency
studies in order to submit a new drug application in 2021,
finalizing our pivotal development plan for the PK activation
program in thalassemia and establishing proof-of-concept in sickle
cell disease. In addition, we are driving enrollment in several
Phase 3 studies for our IDH inhibitors in both malignant hematology
and solid tumors. Our commercial team is focused on achieving an
ambitious revenue target for TIBSOVO® and increasing market
development activities in preparation for a potential launch in PK
deficiency.”
ANTICIPATED 2020 KEY MILESTONES
Agios expects the following key milestones in 2020:
Hematologic Malignancies
- Deliver full-year U.S. revenue for TIBSOVO® of $105-115
million
- Receive European Medicines Agency CHMP opinion for TIBSOVO® in
relapsed or refractory acute myeloid leukemia (AML) with an IDH1
mutation by year-end
- Complete enrollment of the Phase 3 AGILE trial of TIBSOVO® in
combination with azacitidine in adult patients with previously
untreated IDH1 mutant AML by year-end
- Complete enrollment of the relapsed or refractory
myelodysplastic syndrome arm of the TIBSOVO® Phase 1 study of IDH1
mutant advanced hematologic malignancies by year-end
Solid Tumors
- File supplemental new drug application (sNDA) for TIBSOVO® in
previously treated IDH1 mutant cholangiocarcinoma by year-end
Rare Genetic Diseases
- Announce topline data for ACTIVATE and ACTIVATE-T pivotal
trials for mitapivat in adults with pyruvate kinase (PK) deficiency
by year-end
- Submit updated data from the Phase 2 study of mitapivat in
thalassemia for presentation at the European Hematology Association
(EHA) Congress in June and finalize pivotal development strategy by
year-end
- Achieve proof-of-concept for mitapivat in sickle cell disease
by mid-2020
- Receive investigational new drug (IND) clearance for AG-946, a
next generation PKR activator, and initiate a first-in-human study
in healthy volunteers in the first half of 2020
Research
- Achieve at least one new development candidate by year-end
FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL
RESULTS
Revenue: Total revenue for the fourth quarter
of 2019 was $35.4 million, which includes $12.9 million in
collaboration revenue, $19.6 million of net product revenue from
sales of TIBSOVO® and $3.0 million in royalty revenue from net
global sales of IDHIFA® under our collaboration agreement
with Celgene. This compares to $30.0 million for the fourth
quarter of 2018, which included $18.4 million in collaboration
revenue, $9.4 million of net product revenue from U.S. sales of
TIBSOVO® and $2.2 million in royalty revenue from net global sales
of IDHIFA®. Total revenue for the year ended December 31, 2019 was
$117.9 million compared to $94.4 million for the year ended
December 31, 2018. The increase in 2019 revenue was primarily
driven by net U.S. sales of TIBSOVO® and were offset by a decline
in collaboration revenue due to the recognition of a milestone from
Celgene and the upfront payment from CStone in 2018.
Cost of Sales: Cost of sales were $0.3 million
for the fourth quarter of 2019 compared to $0.7 million for the
fourth quarter of 2018, and $1.3 million for the year ended
December 31, 2019 compared to $1.4 million for the comparable
period in 2018.
Research and Development (R&D) Expenses:
R&D expenses were $106.2 million for the fourth quarter of
2019 compared to $93.8 million for the fourth quarter of 2018 and
$410.9 million for the year ended December 31, 2019 compared
to $341.3 million for the comparable period in 2018. The
increase in R&D expense was primarily attributable to clinical
trial activity for mitapivat in PK deficiency and thalassemia;
start-up costs for the vorasidenib Phase 3 INDIGO study in
low-grade glioma, including required clinical pharmacology studies
and companion diagnostic development; and ongoing enrollment in the
TIBSOVO® Phase 3 AGILE and HOVON frontline AML combination studies.
R&D expense also increased as a result of ongoing research
efforts across our discovery platform programs.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $34.8 million for the
fourth quarter of 2019 compared to $31.9 million for the fourth
quarter of 2018, and $132.0 million for the year
ended December 31, 2019 compared to $114.1 million for
the year ended December 31, 2018. The increase in SG&A
expense was primarily attributable to increased investment in
marketing activities in preparation for the potential launch of
mitapivat and personnel costs related to increased headcount to
support growing operations.
Net Loss: Net loss was $102.4 million for the
fourth quarter of 2019 compared to $91.8 million for the fourth
quarter of 2018, and $411.5 million for the year
ended December 31, 2019 compared to a net loss of $346.0
million for the year ended December 31, 2018.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of December 31, 2019
were $717.8 million compared to $805.4 million as
of December 31, 2018. The change in cash was primarily driven
by expenditures to fund operations of $464.4 million offset by the
net proceeds of $277.2 million from the November
follow-on offering and cash inflows of $99.3 million from product
sales, stock option exercises, royalty revenue, and collaboration
reimbursements and milestones. The company expects that its cash,
cash equivalents and marketable securities as of December 31, 2019,
together with anticipated product and royalty revenue, anticipated
interest income, and anticipated expense reimbursements under our
collaboration and license agreements, but excluding any additional
collaboration-related payments, will enable the company to fund its
anticipated operating expenses and capital expenditure requirements
through at least the end of 2021.
CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides
today at 8:00 a.m. ET to discuss fourth quarter and full year 2019
financial results and recent business activities. To participate in
the conference call, please dial 1-877-377-7098 (domestic) or
1-631-291-4547 (international) and referring to conference ID
4195413. The live webcast can be accessed under “Events &
Presentations” in the Investors section of the company's website at
www.agios.com. The archived webcast will be available on the
company's website beginning approximately two hours after the
event.
About Agios/Celgene Collaboration IDHIFA®
(enasidenib) and AG-270 are part of our collaboration with Celgene
Corporation, a wholly owned subsidiary of Bristol-Myers Squibb
Company. Under the terms of our 2010 collaboration agreement
focused on cancer metabolism, Celgene has worldwide development and
commercialization rights for IDHIFA®. Agios continues to conduct
certain clinical development activities within the IDHIFA®
development program and is eligible to receive reimbursement for
those development activities and up to $80 million in remaining
milestone payments, and royalties on any net sales. Celgene and
Agios are currently co-commercializing IDHIFA® in the U.S. Celgene
will reimburse Agios for costs incurred for its
co-commercialization efforts. AG-270 is part of a 2016 global
research collaboration agreement with Celgene focused on metabolic
immuno-oncology. Celgene has the option to participate in a
worldwide 50/50 cost and profit share with Agios, under which Agios
is eligible for up to $169 million in clinical and regulatory
milestone payments for the program.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat malignant
hematology, solid tumors and rare genetic diseases through
scientific leadership in the field of cellular metabolism. In
addition to an active research and discovery pipeline across these
three therapeutic areas, Agios has two approved oncology precision
medicines and multiple first-in-class investigational therapies in
clinical and/or preclinical development. For more information,
please visit the company's website at www.agios.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding Agios’ plans, strategies and expectations for its and its
collaborator’s preclinical, clinical and commercial advancement of
its drug development programs including TIBSOVO® (ivosidenib),
IDHIFA® (enasidenib), mitapivat, vorasidenib, AG-270, AG-636 and
AG-946; the potential benefits of Agios' product candidates; its
key milestones and guidance for 2020; its plans regarding future
data presentations; its financial guidance regarding the period in
which it will have capital available to fund its operations; and
the potential benefit of its strategic plans and focus. The words
“anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,”
“potential,” “possible,” “strategy,” “will,” “vision,” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from Agios' current
expectations and beliefs. For example, there can be no guarantee
that any product candidate Agios or its collaborators is developing
will successfully commence or complete necessary preclinical and
clinical development phases, or that development of any of Agios'
product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios' business will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other important factors, including: Agios' results of
clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by the
U.S. FDA, the EMA or other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; Agios' ability to obtain and maintain
requisite regulatory approvals and to enroll patients in its
planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Agios' ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios'
ability to maintain key collaborations; and general economic and
market conditions. These and other risks are described in greater
detail under the caption "Risk Factors" included in Agios’ public
filings with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Agios expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Consolidated Balance Sheet Data |
(in thousands) |
(Unaudited) |
|
December 31,2019 |
|
December 31,2018 |
Cash, cash equivalents and marketable securities |
$ |
717,806 |
|
$ |
805,421 |
Accounts receivable, net |
|
8,952 |
|
|
5,076 |
Collaboration receivable –
related party |
|
1,539 |
|
|
2,462 |
Royalty receivable – related
party |
|
2,900 |
|
|
2,234 |
Inventory |
|
7,331 |
|
|
869 |
Total assets |
|
890,741 |
|
|
858,457 |
Deferred revenue – related
party |
|
61,513 |
|
|
92,519 |
Stockholders' equity |
|
640,528 |
|
|
687,537 |
Consolidated Statements of Operations Data |
(in thousands, except share and per share
data) |
(Unaudited) |
|
Three Months
Ended December 31, |
|
Years Ended
December 31, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
19,564 |
|
$ |
9,376 |
|
$ |
59,851 |
|
$ |
13,841 |
|
Collaboration revenue – related party |
|
6,843 |
|
|
18,183 |
|
|
39,257 |
|
|
60,661 |
|
Collaboration revenue – other |
|
6,060 |
|
|
230 |
|
|
8,262 |
|
|
12,670 |
|
Royalty revenue – related party |
|
2,973 |
|
|
2,224 |
|
|
10,542 |
|
|
7,215 |
|
Total Revenue |
|
35,440 |
|
|
30,013 |
|
|
117,912 |
|
|
94,387 |
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
Cost of sales |
|
287 |
|
|
702 |
|
|
1,317 |
|
|
1,397 |
|
Research and development, net |
|
106,248 |
|
|
93,809 |
|
|
410,894 |
|
|
341,324 |
|
Selling, general and administrative |
|
34,834 |
|
|
31,858 |
|
|
132,034 |
|
|
114,145 |
|
Total cost and expenses |
|
141,369 |
|
|
126,369 |
|
|
544,245 |
|
|
456,866 |
|
Loss from operations |
|
(105,929) |
|
|
(96,356) |
|
|
(426,333) |
|
|
(362,479) |
|
Interest income |
|
3,579 |
|
|
4,562 |
|
|
14,861 |
|
|
16,451 |
|
Net loss |
$ |
(102,350) |
|
$ |
(91,794) |
|
$ |
(411,472) |
|
$ |
(346,028) |
|
Net loss per share – basic and
diluted |
$ |
(1.60) |
|
$ |
(1.58) |
|
$ |
(6.86) |
|
$ |
(6.03) |
|
Weighted-average number of common
shares used in computing net loss per share – basic and
diluted |
|
63,949,870 |
|
|
58,189,254 |
|
|
59,994,539 |
|
|
57,418,300 |
|
Contacts
Investors:Holly Manning, 617-844-6630Associate
Director, Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Associate
Director, Corporate CommunicationsJessica.Rennekamp@agios.com
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