Agios Reports Business Highlights and Second Quarter 2021 Financial Results
July 29 2021 - 7:00AM
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 second
quarter ended June 30, 2021.
“Our first quarter as a company solely focused on genetically
defined diseases was marked by several significant milestones, most
notably our U.S. and EU regulatory submissions for mitapivat for
the treatment of adults with PK deficiency, bringing us one step
closer to potentially delivering the first disease-modifying
treatment for people with this serious and underserved condition,”
said Jackie Fouse, Ph.D., chief executive officer at Agios. “We
continue to unlock the potential of mitapivat for people with other
chronic hemolytic anemias and are gaining momentum on our pivotal
programs in thalassemia and sickle cell disease. This year, we look
forward to initiating our two registrational Phase 3 trials –
ENERGIZE and ENERGIZE-T – in not regularly transfused and regularly
transfused adults with thalassemia, as well as our pivotal Phase
2/3 trial of mitapivat in sickle cell disease.”
SECOND QUARTER 2021 & RECENT
HIGHLIGHTS
- Completed two regulatory filings for approval of mitapivat in
adults with PK deficiency; submitted new drug application (NDA) in
the U.S. and marketing authorization application (MAA) in the
EU.
- Presented full analysis of data from Phase 3 ACTIVATE and
ACTIVATE-T studies of mitapivat in adults with PK deficiency at
European Hematology Association (EHA) Virtual Congress; studies met
primary and secondary endpoints, including patient-reported outcome
(PRO) measures that address symptom burden and quality-of-life
impact in adults.
- Presented data from Phase 2, open-label, multicenter study of
mitapivat in adults with non-transfusion dependent α- or
β-thalassemia at EHA Virtual Congress; study met its primary
endpoint, with 16 of the 20 patients (80%) achieving a hemoglobin
increase of ≥1.0 g/dL from baseline at one or more assessments
during Weeks 4-12.
- Launched myAgios® patient support services for people living
with PK deficiency and their caregivers, providing tailored
support, educational resources and opportunities to connect with
other patients and caregivers in the community.
- Completed hiring and training of customer-facing and patient
support team that will support the U.S. launch of mitapivat in PK
deficiency upon product approval.
- Announced succession plan for Chris Bowden, M.D., who will
transition from his role as chief medical officer to strategic
advisor following his retirement on Sept. 1, at which time Sarah
Gheuens, M.D., Ph.D., vice president of clinical development, will
assume the role.
- Repurchased approximately 10.5 million shares of Agios common
stock, inclusive of shares acquired from Bristol-Myers Squibb
Company (BMS) and its affiliates, at an average price of $50.41 per
share. This accounts for $529 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.
KEY UPCOMING MILESTONES
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and
ENERGIZE-T, in not regularly transfused and regularly transfused
adults with thalassemia, by year-end.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by
year-end.
- Host investor day in fourth quarter to share more information
about commercial launch planning for mitapivat in PK deficiency and
research and development pipeline.
Data Presentations
- Submit data from ongoing collaborator-led clinical studies of
mitapivat in sickle cell disease for presentation at the 63rd
American Society of Hematology (ASH) Annual Meeting &
Exposition, to be held Dec. 11-14.
- Submit data from the Phase 1 healthy volunteer study of AG-946,
the company's next-generation PKR activator, for presentation at
the 63rd ASH Annual Meeting & Exposition.
SECOND 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 $62.0 million for the second quarter of 2021 compared
to $54.1 million for the second 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 the NDA and MAA
filings for mitapivat in PK deficiency and launch preparation
activities.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses for continuing operations
were $29.2 million for both the second quarter of 2021
and the second quarter of 2020.
Non-Operating Income: Non-operating income
included approximately $2.0 million from TIBSOVO® (ivosidenib)
royalties for the second quarter of 2021.
Net Loss: Net loss was $86.2 million
for the second quarter of 2021 compared to a net loss of $90.5
million for the second quarter of 2020.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of June 30,
2021, were $1.7 billion compared to $794.4
million as of June 30, 2020. The company expects that its
cash, cash equivalents and marketable securities as of June
30, 2021 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 second 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 2663508. 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 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; its
chief medical officer transition plan 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) |
|
|
June 30, 2021 |
|
December 31,2020 |
|
Cash, cash equivalents and marketable securities |
$ |
1,734,301 |
|
$ |
670,537 |
|
Assets held for discontinued
operations |
|
- |
|
|
50,460 |
|
Total assets |
|
1,874,603 |
|
|
852,952 |
|
Liabilities held for
discontinued operations |
|
- |
|
|
299,728 |
|
Stockholders' equity |
|
1,721,816 |
|
|
399,500 |
|
Consolidated Statements of Operations Data |
(in thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Cost and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
62,007 |
|
|
$ |
54,086 |
|
|
$ |
119,674 |
|
|
$ |
109,445 |
|
Selling, general and administrative |
$ |
29,215 |
|
|
$ |
29,178 |
|
|
$ |
62,765 |
|
|
$ |
60,849 |
|
Total
cost and expenses |
$ |
91,222 |
|
|
$ |
83,264 |
|
|
$ |
182,439 |
|
|
$ |
170,294 |
|
Loss from operations |
$ |
(91,222 |
) |
|
$ |
(83,264 |
) |
|
$ |
(182,439 |
) |
|
$ |
(170,294 |
) |
Gain on sale of oncology
business |
$ |
2,000 |
|
|
$ |
- |
|
|
$ |
2,000 |
|
|
$ |
- |
|
Interest (expense) income,
net |
$ |
(92 |
) |
|
$ |
1,769 |
|
|
$ |
248 |
|
|
$ |
4,705 |
|
Other
income, net |
$ |
6,524 |
|
|
$ |
- |
|
|
$ |
6,524 |
|
|
$ |
- |
|
Net loss from continuing
operations |
$ |
(82,790 |
) |
|
$ |
(81,495 |
) |
|
$ |
(173,667 |
) |
|
$ |
(165,589 |
) |
Net
income (loss) from discontinued operations, net of tax |
$ |
(3,427 |
) |
|
$ |
(8,983 |
) |
|
$ |
1,961,775 |
|
|
$ |
34,855 |
|
Net
income (loss) |
$ |
(86,217 |
) |
|
$ |
(90,478 |
) |
|
$ |
1,788,108 |
|
|
$ |
(130,734 |
) |
Net loss from continuing
operations per share - basic and diluted |
$ |
(1.36 |
) |
|
$ |
(1.18 |
) |
|
$ |
(2.66 |
) |
|
$ |
(2.41 |
) |
Net income (loss) from
discontinued operations per share - basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.13 |
) |
|
$ |
30.05 |
|
|
$ |
0.51 |
|
Net
income (loss) per share - basic and diluted |
$ |
(1.41 |
) |
|
$ |
(1.31 |
) |
|
$ |
27.39 |
|
|
$ |
(1.90 |
) |
Weighted-average number of common shares used in computing net
income (loss) per share – basic and diluted |
|
61,066,977 |
|
|
|
68,958,091 |
|
|
|
65,281,827 |
|
|
|
68,784,109 |
|
Contacts
Investors:Steve Klass,
1ABsteve@1abmedia.com
Media:Jessica Rennekamp, 857-209-3286Director,
Corporate CommunicationsJessica.Rennekamp@agios.com
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