Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field
of cellular metabolism to treat cancer and rare genetic diseases,
today reported business highlights and financial results for the
third quarter ended September 30, 2019.
“The third quarter was marked by strong commercial execution,
now a full year since the U.S. launch of TIBSOVO®, and several
meaningful clinical updates spanning our early and late stage
oncology programs that advance our strategy,” said Jackie Fouse,
Ph.D., chief executive officer at Agios. “As we look ahead to the
remainder of 2019, we are focused on achieving our remaining key
milestones, including completing enrollment in our mitapivat PK
deficiency pivotal program, establishing proof of concept for
mitavipat in thalassemia, initiating our pivotal trial of
vorasidenib in low-grade glioma and submission of the TIBSOVO®
supplemental new drug application for IDH1 mutant
cholangiocarcinoma. These milestones are critical steps toward
realizing the value-creation potential for both our oncology and
rare genetic disease portfolios in 2020 and beyond.”
THIRD QUARTER 2019 HIGHLIGHTS & RECENT
PROGRESS
- Presented data from the single agent dose-escalation portion of
the ongoing Phase 1 study of AG-270 in patients with
methylthioadenosine phosphorylase (MTAP)-deleted tumors at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics in October. The data demonstrated that AG-270
induces reductions in the biomarkers of methionine
adenosyltransferase 2A (MAT2A) inhibition, notably plasma
concentrations of S-adenosylmethionine (SAM) and tumor levels of
symmetrically demethylated arginine (SDMA), at well tolerated
doses.
- Presented results from the Phase 3 ClarIDHy study of TIBSOVO®
in previously treated isocitrate dehydrogenase-1 (IDH1) mutant
cholangiocarcinoma at the European Society for Medical Oncology
Congress in September, demonstrating significant improvement in
progression free survival compared to placebo.
- Initiated two combination arms for the Phase 1 study of AG-270
in MTAP-deleted tumors, one evaluating AG-270 in combination with
docetaxel in MTAP-deleted second-line non-small cell lung cancer
and another in combination with nab-paclitaxel and gemcitabine in
MTAP-deleted first or second-line pancreatic ductal
adenocarcinoma.
- Published new data from the core and extension phases of the
DRIVE PK Phase 2 study of mitapivat in adults with pyruvate kinase
(PK) deficiency in the September 5, 2019 issue of the New England
Journal of Medicine, demonstrating sustained increases in
hemoglobin for up to 35 months.
KEY UPCOMING MILESTONES
The company plans to achieve the following key milestones in the
remainder of 2019:
Oncology:
- Submit a supplemental new drug application to the FDA for
TIBSOVO® for previously treated IDH1 mutant cholangiocarcinoma by
year-end.
- Initiate the registration-enabling Phase 3 INDIGO study of
vorasidenib in Grade 2 non-enhancing glioma with an IDH mutation by
year-end. The study will evaluate 366 patients in 1:1 double-blind
randomization to either 50 mg of vorasidenib once daily or placebo.
The primary endpoint is progression free survival.
Rare Genetic Diseases:
- Complete enrollment in two global pivotal trials for mitapivat
in adults with PK deficiency by year-end:
- ACTIVATE-T: A single-arm trial of up to 40 regularly transfused
patients
- ACTIVATE: A 1:1 randomized, placebo-controlled trial of up to
80 patients who do not receive regular transfusions
- Achieve proof-of-concept for mitapivat in thalassemia in the
second half of 2019.
REMAINING 2019 DATA PRESENTATIONS
- Updated data from the perioperative study of TIBSOVO® and
vorasidenib in low-grade glioma have been accepted for presentation
at the Society for Neuro-Oncology Annual Meeting taking place in
Phoenix from November 22-24, 2019.
- Data from the IDH and PKR programs have been accepted for
presentation at the American Society of Hematology Annual Meeting
taking place in Orlando, Fla. from December 7-10, 2019, including
new data from the extension phase of the Phase 2 DRIVE PK study of
mitapivat in adults with PK deficiency and important translational
data from the Phase 1 combination study of TIBSOVO® and azacitidine
in frontline acute myeloid leukemia (AML).
THIRD QUARTER 2019 FINANCIAL RESULTS
Revenue: Total revenue for the third quarter of
2019 was $26.0 million, which includes $17.4 million of net product
revenue from U.S. sales of TIBSOVO®, $5.5 million in collaboration
revenue and $2.7 million in royalty revenue from net global sales
of IDHIFA® under our collaboration agreement with Celgene. This
compares to total revenue of $15.2 million for the third quarter of
2018.
Cost of Sales: Cost of sales were $0.4 million
for the third quarter of 2019.
Research and Development (R&D) Expenses:
R&D expenses were $101.7 million for the third quarter of 2019
compared to $82.6 million for the third quarter of 2018. The
increase in R&D expense was primarily attributable to start-up
costs for the Phase 3 INDIGO study of vorasidenib in IDH mutated
low-grade glioma, the mitapivat pivotal program in PK deficiency
and Phase 2 study in thalassemia, and costs of the ongoing Phase 3
TIBSOVO® combination trials in the frontline AML setting.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $33.0 million for the
third quarter of 2019 compared to $31.1 million for the third
quarter of 2018.
Net Loss: Net loss was $106.2 million for the
third quarter of 2019 compared to $94.7 million for the third
quarter of 2018.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of September 30, 2019 were
$540.5 million compared to $805.4 million as of December 31, 2018.
The net decrease of $264.9 million in cash position was primarily
driven by net expenditures to fund operations. The company expects
that its cash, cash equivalents and marketable securities as of
September 30, 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 program-specific milestone payments, will
enable the company to fund its anticipated operating expenses and
capital expenditure requirements through at least the end of
2020.
CONFERENCE CALL INFORMATIONAgios will host a
conference call and live webcast with slides today at 8:00 a.m. ET
to discuss third quarter 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
refer to conference ID 5996044. 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 AgiosAgios is focused on discovering and
developing novel investigational medicines to treat cancer and rare
genetic diseases through scientific leadership in the field of
cellular metabolism and adjacent areas of biology. In addition to
an active research and discovery pipeline across both therapeutic
areas, Agios has two approved oncology precision medicines and
multiple first-in-class investigational therapies in clinical
and/or preclinical development. All Agios programs focus on
genetically identified patient populations, leveraging our
knowledge of metabolism, biology and genomics. For more
information, please visit the company's website at
www.agios.com.
About Agios/Celgene Collaboration IDHIFA®
(enasidenib) and AG-270 are part of our collaboration with Celgene
Corporation. 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.
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®, IDHIFA®,
vorasidenib, mitapivat, AG-270 and AG-636; the potential benefits
of Agios’ product candidates; its key milestones for 2019; 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,” “hope,”
“milestone,” “plan,” “potential,” “possible,” “strategy,” “will,”
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 inthis 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
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.
Condensed
Consolidated Balance Sheet Data |
(in
thousands) |
(Unaudited) |
|
September 30, 2019 |
|
December 31, 2018 |
Cash, cash equivalents and marketable securities |
$ |
540,476 |
|
$ |
805,421 |
Accounts
receivable, net |
|
7,106 |
|
|
5,076 |
Collaboration receivable – related party |
|
1,838 |
|
|
2,462 |
Royalty
receivable – related party |
|
2,600 |
|
|
2,234 |
Inventory |
|
5,849 |
|
|
869 |
Total
assets |
|
698,616 |
|
|
858,457 |
Deferred
revenue – related party |
|
66,670 |
|
|
92,519 |
Stockholders' equity |
|
448,291 |
|
|
687,537 |
|
|
|
|
Condensed
Consolidated Statements of Operations Data |
(in
thousands, except share and per share data) |
(Unaudited) |
|
Three Months
Ended September 30 |
|
Nine Months
Ended September 30 |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
17,422 |
|
|
$ |
4,465 |
|
|
$ |
40,287 |
|
|
$ |
4,465 |
|
Collaboration revenue – related party |
|
5,516 |
|
|
|
8,732 |
|
|
|
32,414 |
|
|
|
42,478 |
|
Collaboration revenue – other |
|
420 |
|
|
|
- |
|
|
|
2,202 |
|
|
|
12,440 |
|
Royalty revenue – related party |
|
2,666 |
|
|
|
2,001 |
|
|
|
7,569 |
|
|
|
4,991 |
|
Total
Revenue |
|
26,024 |
|
|
|
15,198 |
|
|
|
82,472 |
|
|
|
64,374 |
|
|
|
|
|
|
|
|
|
Cost and
expenses: |
|
|
|
|
|
|
|
Cost of sales |
|
393 |
|
|
|
695 |
|
|
|
1,030 |
|
|
|
695 |
|
Research and development, net |
|
101,672 |
|
|
|
82,561 |
|
|
|
304,646 |
|
|
|
247,515 |
|
Selling, general and administrative |
|
33,019 |
|
|
|
31,104 |
|
|
|
97,200 |
|
|
|
82,287 |
|
Total cost
and expenses |
|
135,084 |
|
|
|
114,360 |
|
|
|
402,876 |
|
|
|
330,497 |
|
Loss from
operations |
|
(109,060 |
) |
|
|
(99,162 |
) |
|
|
(320,404 |
) |
|
|
(266,123 |
) |
Interest
income |
|
2,887 |
|
|
|
4,498 |
|
|
|
11,282 |
|
|
|
11,889 |
|
Net
loss |
$ |
(106,173 |
) |
|
$ |
(94,664 |
) |
|
$ |
(309,122 |
) |
|
$ |
(254,234 |
) |
Net loss per
share – basic and diluted |
$ |
(1.81 |
) |
|
$ |
(1.63 |
) |
|
$ |
(5.27 |
) |
|
$ |
(4.45 |
) |
Weighted-average number of common shares used in computing net loss
per share – basic and diluted |
|
58,803,534 |
|
|
|
58,033,386 |
|
|
|
58,661,607 |
|
|
|
57,158,492 |
|
|
|
|
|
|
|
|
|
Investor & Media Contact:Holly Manning,
617-844-6630Associate Director, Investor
RelationsHolly.Manning@agios.com
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