Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose
mission is to develop medicines that meaningfully improve and
extend the lives of patients facing deadly diseases, today reported
financial results for the third quarter ended September 30, 2022
and provided an operational update.
“Having executed an intentional strategy to narrow the focus of
the company on oncology therapies most likely to have profound
impact on patients and create the greatest value for shareholders,
we are pleased with our strong execution and progress in the third
quarter,” said Mike Sherman, Chief Executive Officer of
Chimerix.
“During the quarter, we completed agreements with Biomedical
Advanced Research and Development Authority (BARDA) and Emergent
BioSolutions (Emergent), and booked our first product revenue with
international governments which collectively secured over $270
million in non-dilutive funding to support our oncology pipeline.
We also completed discussion with the FDA on the design of our
global Phase 3 ACTION study of ONC201 in patients with H3
K27M-mutant glioma. We are targeting initiation of that study
during the upcoming Society for Neuro Oncology Annual Meeting later
this month, where we plan to have a significant presence among
thought leaders in the field. With the expected initiation of the
randomized Phase 3 ACTION study, we now plan to discuss the
potential for an accelerated approval path with the FDA based upon
the strength of the Phase 2 efficacy data, additional safety data,
and the continued significant unmet need for patients with this
rare brain tumor,” continued Mr. Sherman.
“With our lead program fully funded through potential commercial
launch, we will continue to exercise financial discipline with
regard to capital allocation,” added Mike Andriole, Chief Business
Officer and Chief Financial Officer. “We are primarily relying on
external, non-dilutive sources of capital to fund our earlier stage
pipeline programs. As such, any acceleration of investment in these
programs will follow promising data. In the meantime, we remain
disciplined with spend across the organization as we complete the
transition of TEMBEXA®to Emergent.”
ONC201 for Treatment of H3 K27M-Mutant Diffuse
Glioma
The Phase 3 ACTION study is a randomized, double-blind,
placebo-controlled, multicenter international study of ONC201 in
newly diagnosed diffuse glioma patients whose tumor harbors an H3
K27M-mutation. Treatment with ONC201 will occur shortly after
completion of radiation therapy. The study is designed to enroll
450 patients randomized 1:1:1 to receive ONC201 at one of two
dosing frequencies or placebo. Participants will be randomized to
receive 625mg of ONC201 once per week (the Phase 2 dosing regimen),
625mg twice per week on two consecutive days or placebo. The dose
will be scaled by body weight for pediatric patients.
“We view a higher probability of success for the ACTION trial
relative to other Phase 3 trials in neuro oncology,” said, Allen
Melemed, M.D., Chief Medical Officer of Chimerix. “Our Phase 2 data
demonstrated single agent durable responses in the relapse setting,
which strictly followed FDA’s guidance for patient selection. This
change in disease progression among responders included consistent
and strong association between response and other clinical
endpoints, including overall survival. Moving to an earlier line of
treatment in this same genetically defined patient population and
adding a more frequent dose arm in the ACTION study should enhance
clinical activity beyond what was observed in the positive Phase 2
study results. In addition, the ACTION study design includes a
number of interim readouts to claim significance in an expedited
fashion.”
The Company has scheduled a meeting with the FDA to discuss the
potential for an accelerated approval submission for ONC201. In
addition to efficacy data previously provided to the FDA, this
discussion will build on Chimerix’ recent alignment with the Agency
for the Phase 3 ACTION study design and the Company’s plans to
enroll this study while the accelerated approval review process is
underway. New information supporting this discussion include a
211-patient safety dataset and a healthy volunteer dose escalation
study, which both support the attractive safety profile of ONC201
and inform its overall benefit/risk assessment. Chimerix will
incorporate FDA feedback into its decision to proceed with a New
Drug Application (NDA) for accelerated approval.
TEMBEXA®
In September, Chimerix announced the closing of its sale of
TEMBEXA to Emergent and received a payment of $238 million
with the potential for additional milestones of up to $136.5
million. Chimerix is also eligible for double-digit royalties on
gross profit internationally and on gross profit associated with
volumes greater than 1.7 million treatment courses in the U.S.
Third Quarter 2022 Financial Results
For the quarter ending September 30, 2022, Chimerix reported net
income of $241.4 million, or $2.75 per basic and diluted share.
Chimerix recorded a net loss of $18.6 million, or $0.21 per basic
and diluted share, for the third quarter of 2021.
Revenues for the third quarter of 2022 increased to $32.6
million, compared to $0.1 million for the same period in 2021
related to the international procurement sales of TEMBEXA.
Research and development expenses increased to $15.3 million for
the third quarter of 2022, compared to $13.8 million for the same
period in 2021 driven primarily by ongoing development expenses
related to ONC201.
General and administrative expenses increased to $5.3 million
for the third quarter of 2022, compared to $4.9 million for the
same period in 2021.
The sale of TEMBEXA to Emergent BioSolutions, Inc. was recorded
as a $229.7 million gain on a sale. Chimerix utilized net operating
losses to offset federal tax liabilities and will incur nominal
state tax expense.
Chimerix's balance sheet as of September 30, 2022, included
approximately $285 million of capital available to fund operations,
no debt and approximately 88.0 million outstanding shares of common
stock.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss third quarter 2022 financial results and provide a business
update today at 8:30 a.m. ET. To access the live conference call,
please dial (646) 307-1963 (domestic) or (800) 715-9871
(international) at least five minutes prior to the start time and
refer to conference ID 2765632.
A live audio webcast of the call will also be available on the
Investors section of Chimerix’s website, www.chimerix.com. An
archived webcast will be available on the Chimerix website
approximately two hours after the event.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to
develop medicines that meaningfully improve and extend the lives of
patients facing deadly diseases. The Company’s most advanced
clinical-stage development program, ONC201, is in development for
H3 K27M-mutant glioma.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include those relating to, among other things, the initiation and
probability of success of the Phase 3 ACTION study, the potential
for accelerated approval of ONC201, and potential future payments
in connection with the TEMBEXA sale transaction. Among the factors
and risks that could cause actual results to differ materially from
those indicated in the forward-looking statements are risks related
to the timing and completion of the Phase 3 ACTION study of ONC201;
risks associated with the availability of accelerated approval for
ONC201; risks that future payments in connection with the TEMBEXA
sale transaction will not be made; and additional risks set forth
in the Company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the
Company's judgment as of the date of this release. The Company
disclaims, however, any intent or obligation to update these
forward-looking statements.
CONTACTS:
Michelle LaSpaluto919 972-7115ir@chimerix.com
Will O’ConnorStern Investor
Relations212-362-1200will@sternir.com
CHIMERIX,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September,
30 |
|
December
31, |
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
274,261 |
|
|
$ |
15,397 |
|
|
|
Short-term investments, available-for-sale |
|
|
10,369 |
|
|
|
72,970 |
|
|
|
Accounts receivable |
|
|
468 |
|
|
|
- |
|
|
|
Inventories |
|
|
- |
|
|
|
2,760 |
|
|
|
Prepaid expenses and other current assets |
|
|
6,022 |
|
|
|
4,678 |
|
|
|
|
Total current assets |
|
|
291,120 |
|
|
|
95,805 |
|
|
Long-term investments |
|
|
- |
|
|
|
2,022 |
|
|
Property and equipment, net of accumulated depreciation |
|
|
252 |
|
|
|
253 |
|
|
Operating lease right-of-use assets |
|
|
2,078 |
|
|
|
2,404 |
|
|
Other long-term assets |
|
|
430 |
|
|
|
56 |
|
|
|
|
|
Total
assets |
|
$ |
293,880 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,282 |
|
|
$ |
2,788 |
|
|
|
Accrued liabilities |
|
|
14,428 |
|
|
|
13,108 |
|
|
|
Note payable |
|
|
- |
|
|
|
14,000 |
|
|
|
|
Total current liabilities |
|
|
17,710 |
|
|
|
29,896 |
|
|
Loan Fees |
|
|
250 |
|
|
|
- |
|
|
Lease-related obligations |
|
|
1,968 |
|
|
|
2,392 |
|
|
|
|
|
Total
liabilities |
|
|
19,928 |
|
|
|
32,288 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
September 30, 2022 and |
|
|
|
|
|
|
December 31, 2021; no shares issued and outstanding as of September
30, 2022 and |
|
|
|
|
|
|
|
December 31, 2021; no shares issued and outstanding as of September
30, 2022 and |
|
|
- |
|
|
|
- |
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
September 30, 2022 and |
|
|
|
|
|
December 31, 2021; 88,045,127 and 86,884,266 shares issued and
outstanding as of |
|
|
|
|
|
|
|
September 30, 2022 and December 31, 2021, respectively |
|
|
88 |
|
|
|
87 |
|
|
|
Additional paid-in capital |
|
|
966,370 |
|
|
|
953,782 |
|
|
|
Accumulated other comprehensive loss, net |
|
|
(37 |
) |
|
|
(21 |
) |
|
|
Accumulated deficit |
|
|
(692,469 |
) |
|
|
(885,596 |
) |
|
|
|
Total stockholders’ equity |
|
|
273,952 |
|
|
|
68,252 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
293,880 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
CHIMERIX,
INC. |
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|
|
|
|
(in
thousands, except share and per share data) |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Procurement revenue |
|
$ |
31,971 |
|
$ |
- |
|
|
$ |
31,971 |
|
|
$ |
- |
|
|
Contract and grant revenue |
|
|
503 |
|
|
105 |
|
|
|
503 |
|
|
|
1,928 |
|
|
Licensing revenue |
|
|
81 |
|
|
2 |
|
|
|
536 |
|
|
|
5 |
|
|
|
Total revenues |
|
|
32,555 |
|
|
107 |
|
|
|
33,010 |
|
|
|
1,933 |
|
|
Cost of goods sold |
|
|
333 |
|
|
- |
|
|
|
447 |
|
|
|
- |
|
|
|
Gross Profit |
|
|
32,222 |
|
|
107 |
|
|
|
32,563 |
|
|
|
1,933 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
15,263 |
|
|
13,820 |
|
|
|
52,350 |
|
|
|
39,480 |
|
|
General and administrative |
|
|
5,313 |
|
|
4,887 |
|
|
|
16,785 |
|
|
|
13,431 |
|
|
Acquired in-process research and dvelopment |
|
|
- |
|
|
- |
|
|
|
- |
|
|
|
82,890 |
|
|
|
Total operating expenses |
|
|
20,576 |
|
|
18,707 |
|
|
|
69,135 |
|
|
|
135,801 |
|
|
|
|
Income (loss) from operations |
|
|
11,646 |
|
|
(18,600 |
) |
|
|
(36,572 |
) |
|
|
(133,868 |
) |
Other income (loss) income: |
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
199 |
|
|
40 |
|
|
|
182 |
|
|
|
130 |
|
|
Gain on sale of business, net |
|
|
229,670 |
|
|
- |
|
|
|
229,670 |
|
|
|
- |
|
|
|
|
|
Income
(loss) before income taxes |
|
|
241,515 |
|
|
(18,560 |
) |
|
|
193,280 |
|
|
|
(133,738 |
) |
|
Income tax expense |
|
|
153 |
|
|
- |
|
|
|
153 |
|
|
|
- |
|
|
|
|
|
Net
income (loss) |
|
|
241,362 |
|
|
(18,560 |
) |
|
|
193,127 |
|
|
|
(133,738 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on debt investments, net |
|
|
31 |
|
|
11 |
|
|
|
(16 |
) |
|
|
- |
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
241,393 |
|
$ |
(18,549 |
) |
|
$ |
193,111 |
|
|
$ |
(133,738 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
Net income (loss), basic |
|
$ |
2.75 |
|
$ |
(0.21 |
) |
|
$ |
2.21 |
|
|
$ |
(1.59 |
) |
|
Net income (loss), diluted |
|
$ |
2.75 |
|
$ |
(0.21 |
) |
|
$ |
2.17 |
|
|
$ |
(1.59 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic |
|
|
87,634,888 |
|
|
86,335,357 |
|
|
|
87,388,624 |
|
|
|
84,277,555 |
|
|
Weighted-average shares outstanding, diluted |
|
|
87,814,330 |
|
|
86,335,357 |
|
|
|
89,070,831 |
|
|
|
84,277,555 |
|
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