Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field
of cellular metabolism to treat genetically defined diseases, today
reported business highlights and financial results for the third
quarter ended Sept. 30, 2021.
“In the third quarter, we have continued our strong clinical and
operational execution. Following our NDA and MAA filings for
mitapivat for adults with PK deficiency, the team is laser-focused
on launch preparations in this indication, as well as on initiating
three pivotal trials across thalassemia and sickle cell disease by
year-end,” said Jackie Fouse, Ph.D., chief executive officer at
Agios. “As we look ahead to the end of the year and to 2022, Agios
is extremely well-positioned to enter our next phase of growth,
with our first genetically defined disease commercial launch on the
horizon, the expected initiation of three pivotal adult trials and
two pediatric PK deficiency trials and a robust pipeline filled
with optionality and possibility. We look forward to sharing more
insights on our clinical and preclinical pipeline and our
commercial launch efforts at our investor day in November.”
THIRD QUARTER 2021 & RECENT HIGHLIGHTS
- Received Priority Review designation for the new drug
application of mitapivat in PK deficiency by the U.S. Food and Drug
Administration (FDA), accelerating review time from 10 months to
six months from the day of filing acceptance; Prescription Drug
User Fee Act (PDUFA) action date set for Feb. 17, 2022.
- Initiated first global trial sites for Phase 3 ENERGIZE and
ENERGIZE-T studies of mitapivat in not regularly transfused and
regularly transfused adults with α- or β-thalassemia.
- Continued start-up activities for the Phase 2/3 study of
mitapivat in sickle cell disease. In collaboration with a global
team of sickle cell disease patients and caregivers, developed
study name – RISE UP – and unveiled it at the Sickle Cell Disease
Association of America 49th Annual National Convention last
month.
- In Q3, repurchased approximately 5.3 million shares of Agios
common stock at an average price of $47.94 per share. To date, the
company has completed more than $800 million of the up to $1.2
billion of share repurchases authorized by the Board of Directors
following the company’s sale of its oncology business to Servier,
representing a reduction of just over 23% of our starting share
count.
KEY UPCOMING MILESTONES
- Host investor day on Nov. 17 to share updates on the company’s
research and development pipeline, as well as provide additional
insights into the commercial launch strategy and expectations for
mitapivat in PK deficiency.
- Initiate Phase 2/3 RISE UP study of mitapivat in sickle cell
disease by year-end.
Data Presentations
- Submitted the following select data for presentation at
the 63rd American Society of Hematology (ASH) Annual Meeting
& Exposition, hosted Dec. 11-14:
- Long-term efficacy data of mitapivat in adults with PK
deficiency who participated in the Phase 3 ACTIVATE and ACTIVATE-T
trials
- Long-term efficacy and safety data of mitapivat in adults with
thalassemia who do not receive regular transfusions
- Efficacy, safety and translational data of mitapivat in sickle
cell disease from ongoing collaborator-led studies
- Phase 1 healthy volunteer study data of AG-946, the company's
novel PK activator
THIRD QUARTER 2021 FINANCIAL RESULTS
The financial results discussion compares Agios’ continuing
operations. All periods have been adjusted to exclude discontinued
operations related to the divested oncology business.
Research and Development (R&D)
Expenses: R&D expenses for continuing operations
were $64.0 million for the third quarter of 2021 compared
to $51.9 million for the third quarter of 2020. The
year-over-year increase in R&D was driven primarily by start-up
costs associated with the Phase 3 studies of mitapivat in
thalassemia and sickle cell disease, as well as disease education
and engagement efforts for mitapivat in PK deficiency, thalassemia
and sickle cell disease.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses for continuing operations
were $27.2 million for the third quarter of 2021 compared
to $28.3 million for the third quarter of 2020.
Non-Operating Income: Non-operating income
included approximately $2.0 million from TIBSOVO® (ivosidenib)
royalties for the third quarter of 2021.
Net Loss: Net loss was $88.8 million
for the third quarter of 2021 compared to a net loss of $99.0
million for the third quarter of 2020.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of Sept. 30,
2021, were $1.4 billion compared to $722.4
million as of Sept. 30, 2020. The company expects that
its cash, cash equivalents and marketable securities will enable
the company to execute its operating plan through major catalysts
and to cash-flow positivity without the need to raise additional
equity.
CONFERENCE CALL INFORMATIONAgios will host a
conference call and live webcast with slides today at 8:00
a.m. ET to discuss third quarter 2021 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 5748074. 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.
November 17 Investor Event Webcast
InformationAgios will host an investor webcast on November
17, 2021 at 2:00 p.m. ET to discuss the company’s research and
development pipeline, as well as provide additional insights into
the commercial launch strategy and expectations for mitapivat in PK
deficiency. The event will be webcast live and can be accessed
under "Events & Presentations" in the Investors section of
Agios’ website at www.agios.com. The archived webcast will be
available on Agios’ website beginning approximately two hours after
the event.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat genetically
defined diseases through scientific leadership in the field of
cellular metabolism. The company’s most advanced drug candidate is
a first-in-class pyruvate kinase R (PKR) activator, mitapivat, that
is currently being evaluated for the treatment of three distinct
hemolytic anemias. In addition to its active late-stage clinical
pipeline, Agios has multiple novel, investigational therapies in
clinical and 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 the
preclinical, clinical and commercial advancement of its drug
development programs, including mitapivat and AG-946; the potential
benefits of Agios’ products and product candidates; Agios’ key
milestones and guidance for 2021; its financial guidance regarding
the period in which it will have capital available to fund its
operations; expectations regarding the return of capital to
shareholders following the sale of Agios’ oncology business; Agios’
expectations for the FDA’s review of its NDA for mitapivat; and the
potential benefits of Agios’ 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. 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, without limitation risks and
uncertainties related to: the failure of Agios to receive milestone
or royalty payments related to the sale of its oncology business,
the uncertainty of the timing of any receipt of any such payments,
and the uncertainty of the results and effectiveness of the use of
proceeds from the transaction with Servier; the impact of the
COVID-19 pandemic on Agios’ business, operations, strategy, goals
and anticipated milestones, including its ongoing and planned
research activities, ability to conduct ongoing and planned
clinical trials, clinical supply of current or future drug
candidates, commercial supply of future approved products, and
launching, marketing and selling future approved products; 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, including with respect to the regulatory submissions
for mitapivat, 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 and 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 establish and maintain 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, or SEC, including the risks and uncertainties set
forth under the heading Risk Factors in our filings with
the SEC. While the list of factors presented here is
considered representative, this list should not be considered to be
a complete statement of all potential risks and uncertainties. Any
forward-looking statements contained in this communication are made
only as of the date hereof, and we undertake no obligation to
update forward-looking statements to reflect developments or
information obtained after the date hereof and disclaim any
obligation to do so other than as may be required by law.
Consolidated Balance Sheet Data |
(in thousands) |
(Unaudited) |
|
September 30,2021 |
|
December 31,2020 |
Cash, cash equivalents, and marketable securities |
$ |
1,396,196 |
|
$ |
670,537 |
Assets held for discontinued
operations |
|
- |
|
|
50,460 |
Total assets |
|
1,541,498 |
|
|
852,952 |
Liabilities held for
discontinued operations |
|
- |
|
|
299,728 |
Stockholders' equity |
|
1,394,762 |
|
|
399,500 |
Consolidated Statements of Operations Data |
|
(in thousands, except share and per share
data) |
|
(Unaudited) |
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(In thousands, except share
and per share data) |
2021 |
|
2020 |
|
2021 |
|
2020 |
Cost and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
64,000 |
|
|
|
$ |
51,943 |
|
|
|
$ |
183,674 |
|
|
|
$ |
161,388 |
|
|
Selling, general and administrative |
27,152 |
|
|
|
28,347 |
|
|
|
89,917 |
|
|
|
89,196 |
|
|
Total cost and expenses |
91,152 |
|
|
|
80,290 |
|
|
|
273,591 |
|
|
|
250,584 |
|
|
Loss from operations |
(91,152 |
) |
|
|
(80,290 |
) |
|
|
(273,591 |
) |
|
|
(250,584 |
) |
|
Gain on sale of oncology business |
1,996 |
|
|
|
— |
|
|
|
3,996 |
|
|
|
— |
|
|
Interest income, net |
256 |
|
|
|
1,115 |
|
|
|
504 |
|
|
|
5,820 |
|
|
Other income, net |
4,641 |
|
|
|
— |
|
|
|
11,165 |
|
|
|
— |
|
|
Net loss from continuing operations |
(84,259 |
) |
|
|
(79,175 |
) |
|
|
(257,926 |
) |
|
|
(244,764 |
) |
|
Net (loss) income from discontinued operations, net of tax |
(4,507 |
) |
|
|
(19,804 |
) |
|
|
1,957,268 |
|
|
|
15,051 |
|
|
Net (loss) income |
$ |
(88,766 |
) |
|
|
$ |
(98,979 |
) |
|
|
$ |
1,699,342 |
|
|
|
$ |
(229,713 |
) |
|
Net
loss from continuing operations per share - basic and diluted |
$ |
(1.48 |
) |
|
|
$ |
(1.15 |
) |
|
|
$ |
(4.13 |
) |
|
|
$ |
(3.55 |
) |
|
Net (loss) income from
discontinued operations per share - basic and diluted |
$ |
(0.08 |
) |
|
|
$ |
(0.29 |
) |
|
|
$ |
31.31 |
|
|
|
$ |
0.22 |
|
|
Net (loss) income per share -
basic and diluted |
$ |
(1.56 |
) |
|
|
$ |
(1.43 |
) |
|
|
$ |
27.19 |
|
|
|
$ |
(3.33 |
) |
|
Weighted-average number of common shares used in computing net loss
per share from continuing operations, net (loss) income per share
from discontinued operations and net (loss) income per share –
basic and diluted |
57,048,175 |
|
|
|
69,144,061 |
|
|
|
62,503,087 |
|
|
|
68,905,853 |
|
|
Contacts
Investors:Holly Manning, 617-844-6630Senior
Director, Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Director,
Corporate CommunicationsJessica.Rennekamp@agios.com
Agios Pharmaceuticals (NASDAQ:AGIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Agios Pharmaceuticals (NASDAQ:AGIO)
Historical Stock Chart
From Apr 2023 to Apr 2024