--Company reports Glatopa® 20 mg product revenues
of $23 million, a 58% increase over the same period in 2016--
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its
financial results for the first quarter ended March 31, 2017.
“We continue to demonstrate the value of our
Glatopa business both with increased revenues year-over-year for
the 20 mg product and the potential of the 40 mg product to be
launched this year,” said Craig A. Wheeler, President and Chief
Executive Officer of Momenta Pharmaceuticals. “Our biosimilar and
novel autoimmune programs also showed strong momentum. We expect to
submit our biosimilar HUMIRA® candidate for marketing approval
mid-year followed by Phase 1 top-line data for our biosimilar
ORENCIA® candidate, in collaboration with Mylan. For our novel
autoimmune programs, data from the M281 Phase 1 study is expected
in the second half of the year and we expect our lead program with
CSL, M230, to enter the clinic this year.”
First Quarter Highlights and Recent
Events
Complex Generics:
Glatopa 20 mg: First
FDA-approved, substitutable generic daily COPAXONE® 20 mg
(glatiramer acetate injection) for patients with relapsing forms of
multiple sclerosis developed in collaboration with Sandoz.
- In the first quarter of 2017, Momenta recorded $23.4 million in
product revenues from Sandoz’s Glatopa 20 mg sales compared to
$14.8 million in the same period in 2016.
Glatopa 40 mg: Designed to be a
generic version of three-times-a-week COPAXONE 40 mg for patients
with relapsing forms of multiple sclerosis developed in
collaboration with Sandoz.
- The Abbreviated New Drug Application (ANDA) submitted by Sandoz
is under U.S. Food and Drug Administration (FDA) review. On
February 17, 2017, the Company announced that Sandoz’s contracted
fill/finish manufacturing partner for Glatopa, Pfizer, received an
FDA warning letter. An approval of the application may be dependent
on the satisfactory resolution of the compliance observations
stated in the FDA warning letter issued to Pfizer. Pfizer submitted
a comprehensive response to the observations cited in the warning
letter. The Company believes that an approval from the FDA
continues to be possible in 2017.
- On January 30, 2017, the U.S. District Court of Delaware found
four of Teva Pharmaceutical's U.S. Orange Book listed patents for
COPAXONE 40 mg to be invalid due to obviousness. On February 2,
2017, Teva filed a notice of appeal of the decision to the U.S.
Court of Appeals for the Federal Circuit (CAFC). The Company
expects a decision from the CAFC in late 2017 or early 2018.
- Teva has asserted infringement claims under two additional
patents (U.S. Patent Nos. 9,155,775 (“the ‘775 patent)” and
9,402,874 (“the ‘874 patent”)), which claims Momenta believes to be
invalid, not infringed and unenforceable. On April 23, 2017, the
parties filed a joint motion to dismiss the suit for the '874
patent.
Biosimilars:
M923: a fully-owned proposed
biosimilar to HUMIRA (adalimumab)
- In January, the Company received a one-time asset return
payment of $51.2 million from Baxalta, a wholly-owned subsidiary of
Shire plc, for the early termination of the M923 collaboration
agreement.
- Momenta is targeting mid-2017 for the first submission for
marketing approval of M923. Subject to marketing approval and
patent considerations, the Company expects first commercial launch
of M923 to be as early as the 2020 timeframe.
M834: a proposed biosimilar to
ORENCIA (abatacept) being developed in collaboration with Mylan
- In April 2017, the Phase 1 clinical trial for M834 completed
enrollment. The companies plan to report top-line data from the
Phase 1 trial in the second half of 2017.
- On December 22, 2016, the U.S. Patent and Trademark Office’s
Patent Trial and Appeal Board issued their decision upholding the
validity of U.S. Patent No. 8,476,239, related to Bristol Myers
Squibb’s ORENCIA product following the Company’s Inter Partes
Review challenging this patent. The Company has appealed the
decision to the CAFC and expects a decision in April 2018. A motion
to dismiss the appeal is pending.
M710: a biosimilar candidate
being developed in collaboration with Mylan
- The companies continue to progress M710 and expect to initiate
a clinical trial for this program in late 2017, or early 2018.
Novel Drugs for Autoimmune
Indications:
M281 (anti-FcRn): a fully human
monoclonal antibody (mAb) targeting the neonatal Fc receptor
(FcRn)
- In January 2017, the Company initiated the multiple ascending
dose portion of the Phase 1 study in healthy volunteers. To date no
serious adverse events have been observed. The Company plans to
report the full data from the single and multiple ascending dose
portions of the study in the second half of 2017.
M230 (SIF3): a Selective
Immunomodulator of Fc receptors
- On January 5, 2017, the Company announced that it entered into
a worldwide license agreement and an exclusive research
collaboration with CSL to develop and commercialize Fc multimer
proteins, including Momenta’s M230, which is expected to enter the
clinic in 2017.
- On February 17, 2017 the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act (HSR Act) in
connection with the license agreement and research collaboration
with CSL expired. Momenta received a $50 million upfront cash
payment from CSL in March 2017.
M254 (hsIVIg): a robust,
controlled sialylation process to generate tetra-Fc-sialylated
immunoglobulins with consistent enhanced anti-inflammatory
activity
- The Company continues to progress the M254 program and expects
to initiate an IND-enabling toxicology study in 2017 and is
targeting a clinical trial in 2018.
First Quarter 2017 Financial
Results
Revenue: In the first quarter
of 2017, the Company recorded $23.4 million in product revenues
from Sandoz’s sales of Glatopa 20 mg, compared to $14.8 million for
the same period in 2016. The increase in product revenues of $8.6
million, or 58%, was primarily due to a higher number of Glatopa 20
mg units sold. Collaborative research and development revenue for
the first quarter of 2017 was $3.2 million compared to $5.1 million
recorded in the same quarter last year. The decrease in research
and development revenue of $1.9 million, or 37%, was primarily due
to the termination of the Baxalta Collaboration Agreement,
effective December 31, 2016, under which the Company was
reimbursed for M923 employee expenses and external costs and for
which the Company recognized a portion of Baxalta's initial upfront
payment in the first quarter of 2016. Total revenues for the first
quarter of 2017 were $26.6 million compared to $19.9 million for
the same period in 2016.
Operating Expenses: Total GAAP
operating expenses were $59.2 million in the first quarter of 2017.
Research and development expenses for the first quarter of 2017
were $36.1 million, compared to $28.8 million for the same period
in 2016. The increase of $7.3 million, or 25%, was primarily due to
increased spending on M923 as the program was transitioned back to
the Company effective December 31, 2016, as a result of the
termination of the Baxalta Collaboration Agreement.
General and administrative expenses for the
first quarter of 2017 were $23.1 million, compared with $15.6
million for the same period in 2016. The increase of $7.5 million,
or 48%, was primarily driven by increases of $5.0 million relating
to the Company's ongoing litigation and $2.0 million in
personnel-related expenses, of which $1.6 million represents
share-based compensation expense.
First quarter non-GAAP operating expense was
$51.0 million, in line with previously provided guidance of $50 -
$60 million per quarter in 2017.
Net Loss: The Company reported
a net loss of $31.8 million, or $0.46 per share for the first
quarter of 2017 compared to a net loss of $24.0 million, or $0.35
per share for the same period in 2016.
Cash Position: At
March 31, 2017, Momenta had $433.7 million in cash, cash
equivalents and marketable securities compared to $353.2 million at
December 31, 2016. Cash provided by operating activities was
$63.0 million during the first quarter of 2017, driven by the
receipt of $51.2 million from the termination of the Baxalta
Collaboration Agreement and the $50.0 million upfront payment from
CSL pursuant to the worldwide license agreement, as compared to
approximately $13.9 million during the first quarter of 2016.
In April 2015, Momenta entered into an ATM
agreement with Stifel under which the Company may offer and sell
shares of its common stock having an aggregate offering price of up
to $75 million. In the first quarter of 2017, the Company
recorded net proceeds of $18.5 million, of which $4.1 million was
received in April 2017, from the sale of 1.3 million shares of
common stock sold through the ATM agreement.
2017 Financial Guidance
Momenta provides non-GAAP operating expense
guidance, which it believes can enhance an overall understanding of
its financial performance when considered together with GAAP
figures. Refer to the section of this press release below entitled
“Non-GAAP Financial Information and Other Disclosures” for further
discussion of this subject.
Non-GAAP operating expense is total operating
expenses (which excludes collaboration expenses reimbursable by
Mylan), less stock-based compensation expense and collaboration
expenses incurred by the Company that are reimbursable by Sandoz.
Today, Momenta is reiterating non-GAAP operating expense guidance
of approximately $200 - $240 million for 2017 and $50 - $60 million
for the second quarter of 2017. This guidance includes
approximately $55 million of spending on M923 that will now be
included in the Company’s 2017 operating expenses. Of the $55
million, $51 million of the expense has already been paid by Shire
as part of the termination agreement. The quarterly recognition of
collaborative revenues under the Company’s collaboration with
Mylan is expected to be approximately $1.8 million per
quarter. The Company expects to recognize the $50 million upfront
payment from CSL as revenue in the second half of 2017.
Non-GAAP Financial Information and Other
Disclosures
Momenta uses a non-GAAP financial measure,
non-GAAP operating expense, to provide operating expense guidance.
Momenta believes this non-GAAP financial measure is useful to
investors because it provides greater transparency regarding
Momenta’s operating performance and excludes non-cash stock
compensation expense and is net of collaborative reimbursement
revenues from Sandoz. This non-GAAP financial measure should not be
considered an alternative to GAAP total operating expense and
should not be considered a measure of Momenta’s liquidity. Non-GAAP
financial measures should not be considered as substitutes for
measures calculated in accordance with GAAP and should only be used
to supplement an understanding of Momenta’s operating results as
reported under GAAP. Momenta has not provided a GAAP reconciliation
for its forward-looking non-GAAP annual operating expense because
Momenta cannot reliably predict without unreasonable efforts the
timing or amount of the factors that substantially contribute to
the projection of stock compensation expense, which is excluded
from the forward-looking non-GAAP financial measure. The Company
has provided the anticipated reconciling information that is
available without unreasonable effort in the section of this press
release above entitled “2017 Financial Guidance.”
Conference Call Information
Management will host a conference call and
webcast today at 10:00 am ET to discuss these results and provide
an update on the company. A live webcast of the conference call may
be accessed on the “Investors” section of the company’s website,
www.momentapharma.com. Please go to the site at least 15 minutes
prior to the call in order to register, download, and install any
necessary software. An archived version of the webcast will be
posted on the Momenta website approximately two hours after the
call.
To access the call you may also dial (877)
224-9084 (domestic) or (720) 545-0022 (international) prior to the
scheduled conference call time and provide the access code 9265541.
A replay of the call will be available approximately two hours
after the conclusion of the call and will be accessible through May
9, 2017. To access the replay, please dial (855) 859-2056
(domestic) or (404) 537-3406 (international) and provide the access
code 9265541.
About Momenta
Momenta Pharmaceuticals is a biotechnology
company specializing in the detailed structural analysis of complex
drugs and is headquartered in Cambridge, MA. Momenta is
applying its technology to the development of generic versions of
complex drugs, biosimilar and potentially interchangeable
biologics, and to the discovery and development of novel
therapeutics for autoimmune indications.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does
not form a part of this press release.
Our logo, trademarks, and service marks are the
property of Momenta Pharmaceuticals, Inc. All other trade names,
trademarks, or service marks are property of their respective
owners.
Forward Looking Statements
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including
but not limited to statements about the timing of our regulatory
filings seeking marketing approval; the timing of regulatory
approval and launch of our product candidates, including Glatopa 40
mg; the Company’s ability to meet its development and strategic
goals; the dependence of an approval of the Glatopa 40 mg ANDA on
resolution of the compliance observations in the FDA warning letter
issued to Pfizer; expectations regarding long-term growth and
sustainability; future operating expenses; program development;
timing of clinical trials and the availability and announcement of
clinical data; timing of patent litigation and other patent-related
proceedings and decisions related to such litigation and
proceedings; assessment of patents that are the subject of patent
litigation; ability to generate value from our product candidates;
expectations regarding accounting treatment for and recognition of
consideration and revenues under the Company’s collaborations and
how the Company plans to use its current cash balances; reconciling
information; non-GAAP operating expense guidance; utilization of
the April 2015 ATM facility; and interchangeable biologics.
Forward-looking statements may be identified by words such as
"anticipate," “believe,” “continue,” “expect,” “guidance,”
“may,” “plan,” “potential,” “target,” “will” and other similar
words or expressions, or the negative of these words or similar
words or expressions. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors, including
those referred to under the section “Risk Factors” in the Company's
Annual Report on Form 10-K for the year
ended December 31, 2016, filed with
the Securities and Exchange Commission, as well as other
documents that may be filed by the Company from time to time with
the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company's actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. The Company is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
MOMENTA
PHARMACEUTICALS, INC.Unaudited Condensed Consolidated
Balance Sheets(in thousands) |
|
|
March 31, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
433,749 |
|
|
$ |
353,151 |
|
Collaboration
receivable |
26,544 |
|
|
70,242 |
|
Restricted cash |
21,761 |
|
|
21,761 |
|
Other assets |
37,360 |
|
|
32,583 |
|
Total
assets |
$ |
519,414 |
|
|
$ |
477,737 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current
liabilities |
$ |
114,486 |
|
|
$ |
70,676 |
|
Deferred revenue, net
of current portion |
29,653 |
|
|
31,360 |
|
Other long-term
liabilities |
4,960 |
|
|
3,793 |
|
Stockholder's
equity |
370,315 |
|
|
371,908 |
|
Total
liabilities and stockholders’ equity |
$ |
519,414 |
|
|
$ |
477,737 |
|
MOMENTA PHARMACEUTICALS, INC.Unaudited
Condensed Statements of Operations and Comprehensive Loss(in
thousands, except per share amounts) |
|
|
Three Months Ended March 31, |
|
2017 |
|
2016 |
Collaboration
revenues: |
|
|
|
Product
revenue |
$ |
23,404 |
|
|
$ |
14,800 |
|
Research
and development revenue |
3,210 |
|
|
5,050 |
|
Total
collaboration revenue |
26,614 |
|
|
19,850 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Research
and development* |
36,101 |
|
|
28,757 |
|
General
and administrative* |
23,105 |
|
|
15,647 |
|
Total
operating expenses |
59,206 |
|
|
44,404 |
|
|
|
|
|
Operating loss |
(32,592 |
) |
|
(24,554 |
) |
|
|
|
|
Other income |
833 |
|
|
542 |
|
|
|
|
|
Net loss |
$ |
(31,759 |
) |
|
$ |
(24,012 |
) |
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.46 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
Weighted average shares
used in computing basic and diluted net loss per share |
69,711 |
|
|
68,285 |
|
|
|
|
|
* Non-cash
shared-based compensation expense included in operating expenses is
as follows: |
|
|
|
|
Research and
development |
$ |
2,463 |
|
|
$ |
2,065 |
|
General and
administrative |
$ |
4,340 |
|
|
$ |
2,763 |
|
INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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