MacroGenics Provides Update on Corporate Progress and Second Quarter 2023 Financial Results
09 Agosto 2023 - 5:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on developing and commercializing innovative antibody-based
therapeutics for the treatment of cancer, today provided an update
on its recent corporate progress and reported financial results for
the quarter ended June 30, 2023.
“MacroGenics maintains its historical focus on
developing innovative antibody-based therapeutics, and we are very
excited about our continued progress in advancing our two Phase 2
programs in prostate cancer, which engage different yet potentially
complementary mechanisms of action,” said Scott Koenig, M.D.,
Ph.D., President and CEO of MacroGenics. “Additionally, we’ve
expanded our efforts to broaden our antibody-drug conjugate (ADC)
portfolio through technology-enabling partnerships, internal
discovery efforts on first-in-class targets, as well as our
continued antibody engineering expertise. As we’ve indicated
earlier, we intend to submit an investigational new drug (IND)
application to the FDA by year-end for the first of potentially
multiple new ADC molecules which incorporate a topoisomerase
inhibitor payload.”
Updates on Proprietary Investigational
Programs
Recent progress and anticipated events related to
MacroGenics’ investigational product candidates are highlighted
below.
-
Vobramitamab duocarmazine (vobra duo) is an ADC
that targets B7-H3, an antigen with broad expression across
multiple solid tumors and a member of the B7 family of molecules
involved in immune regulation.
- MacroGenics began
enrolling the TAMARACK Phase 2 study of vobra duo in patients with
mCRPC under an amended protocol during the second quarter. This
study is designed to evaluate vobra duo at two different doses, 2.0
mg/kg or 2.7 mg/kg every four weeks, across a total of 100
patients. MacroGenics anticipates enrolling a majority of the study
patients in 2023 and expects to provide a clinical update in
2024.
- MacroGenics
continues to enroll a Phase 1/2 dose escalation study of vobra duo
in combination with lorigerlimab in patients with various advanced
solid tumors. The Company anticipates commencing the dose expansion
portion of the study by year-end 2023.
-
Lorigerlimab is a bispecific, tetravalent PD-1 ×
CTLA-4 DART® molecule. Based on the encouraging lorigerlimab
monotherapy clinical data in mCRPC previously presented at ASCO
Genitourinary Cancers Symposium in February 2023, MacroGenics plans
to commence enrollment of a randomized Phase 2 study of
lorigerlimab in combination with docetaxel vs. docetaxel alone in
second-line, chemotherapy-naïve mCRPC patients in the coming weeks.
A total of 150 patients are planned to be treated in the 2:1
randomized study. The current trial design includes a primary study
endpoint of radiographic progression-free survival (rPFS).
-
MGD024 is a next-generation, humanized CD123 × CD3
DART molecule designed to minimize cytokine-release syndrome, while
maintaining anti-tumor cytolytic activity, and permitting
intermittent dosing through a longer half-life. MacroGenics
continues to enroll patients in a Phase 1 dose-escalation study of
MGD024 in patients with CD123-positive neoplasms, including acute
myeloid leukemia and myelodysplastic syndromes.
-
Enoblituzumab is an Fc-optimized monoclonal
antibody that targets B7-H3. Based on the recently published
results from a Phase 2 investigator-sponsored study of
enoblituzumab in men with prostate cancer, MacroGenics and
collaborators at multiple academic institutions plan to initiate an
investigator-sponsored randomized, translationally intense,
neo-adjuvant prostate cancer study in a high-risk population by
early 2024.
Other Corporate Updates
- $50 million
TZIELD milestone. On July 28, 2023, Sanofi S.A. (Sanofi)
reported that the PROTECT placebo-controlled study investigating
TZIELD in patients with newly diagnosed stage 3 Type 1 diabetes met
its primary endpoint, having demonstrated preservation of beta cell
function. This positive study outcome triggers payment of a $50
million milestone to MacroGenics by Sanofi, pursuant to a March
2023 agreement originally between MacroGenics and DRI Healthcare
Acquisitions LP (DRI), the royalty interest and milestone payment
obligations of which were sold by DRI to a subsidiary of Sanofi in
April 2023.Under the MacroGenics agreement with DRI, since assumed
by a Sanofi subsidiary, MacroGenics retains the right to receive
a 50% share of the royalty on global net sales of TZIELD above a
certain annual threshold. Under this agreement, the Company may
also receive an additional $50 million milestone from Sanofi if
TZIELD achieves a certain level of net sales. In addition,
MacroGenics continues to be eligible to receive additional
economics under the asset purchase agreement with Provention Bio,
Inc.
Second Quarter
2023 Financial Results
- Cash
Position: Cash, cash equivalents and marketable securities
as of June 30, 2023, were $240.3 million, compared to $154.3
million as of December 31, 2022. The Company’s cash balance as
of June 30, 2023 did not include the $50 million milestone from
Sanofi subsequently earned.
-
Revenue: Total revenue was $13.1 million for the
quarter ended June 30, 2023, compared to total revenue of
$26.0 million for the quarter ended June 30, 2022.
- R&D
Expenses: Research and development expenses were $43.2
million for the quarter ended June 30, 2023, compared to $51.7
million for the quarter ended June 30, 2022. The decrease was
primarily related to decreased costs related to discontinued
studies, partially offset by increased expenses related to
preclinical ADC molecules and increased clinical expenses related
to lorigerlimab and vobra duo.
- SG&A
Expenses: Selling, general and administrative expenses
were $13.7 million for each of the quarters ended June 30,
2023 and June 30, 2022.
- Other
Income: Under GAAP guidelines and pursuant to Financial
Accounting Standards Board’s Accounting Standards Codification
(ASC) 470, in March 2023, MacroGenics recorded the $100 million
proceeds received from the sale of the Company’s single-digit
royalty interest on global net sales of TZIELD to DRI as a
“Liability related to future royalties.” This liability was to be
amortized over the term of the arrangement using the effective
interest rate method. In separate transactions, Sanofi subsequently
acquired both Provention Bio, Inc. and the TZIELD royalty interest
and milestone obligations from DRI on April 27, 2023, obviating the
need for MacroGenics’ involvement in the transfer of royalty
payments to DRI. This resulted in a change to the arrangement,
which was evaluated as a modification under the provisions of ASC
470. Accordingly, the Company recognized approximately $100 million
as a component of other income on its financial statements for the
quarter ended June 30, 2023.
- Net Income
(Loss): Net income was $57.5 million for the quarter ended
June 30, 2023, compared to net loss of $41.3 million for the
quarter ended June 30, 2022.
- Shares
Outstanding: Shares of common stock outstanding as of
June 30, 2023 were 61,938,493.
- Cash Runway Guidance:
MacroGenics anticipates that its cash, cash equivalents and
marketable securities balance of $240.3 million as of June 30,
2023, plus the $50 million milestone subsequently earned, in
addition to projected and anticipated future payments from partners
and product revenues should extend its cash runway into 2026. The
Company’s expected funding requirements reflect anticipated
expenditures related to the Phase 2 TAMARACK clinical trial, the
Phase 2 study of lorigerlimab in mCRPC as well as MacroGenics’
other ongoing clinical and preclinical studies.
Conference Call Information
To participate via telephone, please register in
advance at this link. Upon registration, all telephone participants
will receive a confirmation email detailing how to join the
conference call, including the dial-in number along with a unique
passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call can
be accessed under "Events & Presentations" in the Investor
Relations section of MacroGenics’ website at
http://ir.macrogenics.com/events.cfm. A recorded replay of the
webcast will be available shortly after the conclusion of the call
and archived on MacroGenics’ website for 30 days following the
call.
MACROGENICS, INC. |
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(Amounts in thousands) |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Cash, cash equivalents and marketable securities |
$ |
240,347 |
|
$ |
154,346 |
Total assets |
|
305,653 |
|
|
280,468 |
Deferred revenue |
|
68,209 |
|
|
69,468 |
Total stockholders' equity |
|
171,544 |
|
|
142,013 |
|
|
|
|
|
|
MACROGENICS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Unaudited) |
(Amounts in thousands, except share and per share
data) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
Collaborative and other agreements |
$ |
6,021 |
|
|
$ |
16,863 |
|
|
$ |
22,708 |
|
|
$ |
23,956 |
|
|
Product sales, net |
|
5,062 |
|
|
|
4,672 |
|
|
|
8,552 |
|
|
|
8,252 |
|
|
Contract manufacturing |
|
1,587 |
|
|
|
3,992 |
|
|
|
5,202 |
|
|
|
3,992 |
|
|
Royalty revenue |
|
— |
|
|
|
— |
|
|
|
421 |
|
|
|
— |
|
|
Government agreements |
|
466 |
|
|
|
480 |
|
|
|
749 |
|
|
|
908 |
|
|
Total revenues |
|
13,136 |
|
|
|
26,007 |
|
|
|
37,632 |
|
|
|
37,108 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
258 |
|
|
|
180 |
|
|
|
371 |
|
|
|
228 |
|
|
Cost of manufacturing services |
|
919 |
|
|
|
2,222 |
|
|
|
4,329 |
|
|
|
2,222 |
|
|
Research and development |
|
43,229 |
|
|
|
51,744 |
|
|
|
89,101 |
|
|
|
113,182 |
|
|
Selling, general and administrative |
|
13,692 |
|
|
|
13,669 |
|
|
|
27,219 |
|
|
|
29,922 |
|
|
Total costs and expenses |
|
58,098 |
|
|
|
67,815 |
|
|
|
121,020 |
|
|
|
145,554 |
|
|
Loss from operations |
|
(44,962 |
) |
|
|
(41,808 |
) |
|
|
(83,388 |
) |
|
|
(108,446 |
) |
|
Gain on royalty monetization arrangement |
|
100,930 |
|
|
|
— |
|
|
|
100,930 |
|
|
|
— |
|
|
Interest and other income |
|
2,275 |
|
|
|
504 |
|
|
|
3,348 |
|
|
|
699 |
|
|
Interest expense |
|
(774 |
) |
|
|
— |
|
|
|
(1,430 |
) |
|
|
— |
|
|
Net Income (loss) |
|
57,469 |
|
|
|
(41,304 |
) |
|
|
19,460 |
|
|
|
(107,747 |
) |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
(80 |
) |
|
|
(43 |
) |
|
|
(67 |
) |
|
|
(265 |
) |
|
Comprehensive income (loss) |
$ |
57,389 |
|
|
$ |
(41,347 |
) |
|
$ |
19,393 |
|
|
$ |
(108,012 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share: |
|
|
|
|
|
|
|
|
Basic |
$ |
0.93 |
|
|
$ |
(0.67 |
) |
|
$ |
0.31 |
|
|
$ |
(1.76 |
) |
|
Diluted |
$ |
0.92 |
|
|
$ |
(0.67 |
) |
|
$ |
0.31 |
|
|
$ |
(1.76 |
) |
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
61,880,096 |
|
|
|
61,384,943 |
|
|
|
61,845,151 |
|
|
|
61,354,721 |
|
|
Diluted |
|
62,261,646 |
|
|
|
61,384,943 |
|
|
|
62,030,710 |
|
|
|
61,354,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical
company focused on developing, manufacturing and commercializing
innovative monoclonal antibody-based therapeutics for the treatment
of cancer. The Company generates its pipeline of product candidates
primarily from its proprietary suite of next-generation
antibody-based technology platforms, which have applicability
across broad therapeutic domains. The combination of MacroGenics'
technology platforms and protein engineering expertise has allowed
the Company to generate promising product candidates and enter into
several strategic collaborations with global pharmaceutical and
biotechnology companies. For more information, please see the
Company's website at www.macrogenics.com. MacroGenics, the
MacroGenics logo, MARGENZA and DART are trademarks or registered
trademarks of MacroGenics, Inc.
Cautionary Note on Forward-Looking
Statements
Any statements in this press release about future
expectations, plans and prospects for MacroGenics (“Company”),
including statements about the Company’s strategy, future
operations, clinical development of the Company’s therapeutic
candidates, including initiation and enrollment in clinical trials,
expected timing of results from clinical trials, discussions with
regulatory agencies, commercial prospects of or product revenues
from MARGENZA and the Company’s product candidates, if approved,
manufacturing services revenue, milestone or opt-in payments from
the Company’s collaborators, the Company’s anticipated milestones
and future expectations and plans and prospects for the Company, as
well as future global net sales of TZIELD and the Company’s ability
to achieve the milestone payments set forth under the terms of the
agreement with DRI (or its successors or assigns with respect to
such agreement), and other statements containing the words “subject
to”, "believe", “anticipate”, “plan”, “expect”, “intend”,
“estimate”, “potential,” “project”, “may”, “will”, “should”,
“would”, “could”, “can”, the negatives thereof, variations thereon
and similar expressions, or by discussions of strategy constitute
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: risks that TZIELD, vobramitamab
duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product
candidate’s revenue, expenses and costs may not be as expected,
risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab,
ZYNYZ, MARGENZA or any other product candidate’s market acceptance,
competition, reimbursement and regulatory actions; our ability to
provide manufacturing services to our customers; the uncertainties
inherent in the initiation and enrollment of future clinical
trials; the availability of financing to fund the internal
development of our product candidates; expectations of expanding
ongoing clinical trials; availability and timing of data from
ongoing clinical trials; expectations for the timing and steps
required in the regulatory review process; expectations for
regulatory approvals; expectations of future milestone payments;
the impact of competitive products; our ability to enter into
agreements with strategic partners and other matters that could
affect the availability or commercial potential of the Company's
product candidates; business, economic or political disruptions due
to catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); and other risks described in
the Company's filings with the Securities and Exchange Commission.
In addition, the forward-looking statements included in this press
release represent the Company's views only as of the date hereof.
The Company anticipates that subsequent events and developments
will cause the Company's views to change. However, while the
Company may elect to update these forward-looking statements at
some point in the future, the Company specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date hereof.
CONTACTS: Jim Karrels, Senior Vice President, CFO
1-301-251-5172 info@macrogenics.com
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