On May 2, 2019 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, reported its financial results for the first quarter ended March 31, 2019 (Press release, Momenta Pharmaceuticals, MAY 2, 2019, View Source [SID1234535651]).
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"We continue to focus on operational execution to progress our ongoing trials of M281 and M254 towards key proof-of-concept data readouts in 2020," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Additionally, we were proud to share new data on our pipeline this quarter with the publication of preclinical data highlighting both M281’s potential to alter the treatment landscape in fetal-maternal disorders, and the ability of our SIFbody platform and Fc multimerization technology to produce enhanced antibodies across a range of immunomodulating targets."
First Quarter 2019 Highlights, Recent Events and Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
· Vivacity-MG, the Company’s Phase 2 study of M281 in generalized Myasthenia Gravis (gMG), is expected to report top-line results in 2020. Unity, the Company’s global multi-center Phase 2 clinical study of M281 in Hemolytic Disease of the Fetus and Newborn (HDFN), is expected to report top-line results in 2021. This follows the March 2019 announcement that regulatory approvals were obtained in the U.S., Canada and several EU countries and that the Company began activating clinical sites.
·In March 2019, the Company published data in the American Journal of Obstetrics & Gynecology, expanding on its February 2019 presentation at the Society for Maternal-Fetal Medicine 39th Annual Pregnancy Meeting, which highlighted the ability of M281 to inhibit transfer of immunoglobulin G from maternal to fetal circulation in an ex vivo placental perfusion model with minimal transfer of M281 into fetal circulation.
· The Company plans to initiate a third study of M281 in an additional autoimmune indication in 2019.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
· In January 2019, the Company announced that the first subject was dosed in the Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP). The multi-part trial is first enrolling healthy volunteers and includes single and multiple dose studies, and a randomized cross-over study comparing M254 to IVIg. Enrollment for this trial is ongoing and preliminary clinical data is expected in 2020.
M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL
·The Phase 1 clinical trial in healthy volunteers to evaluate the safety and tolerability of M230 continues. Momenta’s partner, CSL expects to complete the Phase 1 study by the end of 2019.
SIFbody Platform and Fc Multimerization Technology:
· The Company presented two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2019, demonstrating the potential of its SIFbody platform and Fc multimerization technology to significantly enhance the potency and efficacy of a variety of cell depleting therapeutic antibodies, including antibodies targeting CD38 and CTLA-4.
Legacy Products:
Glatopa 20 mg and 40 mg: FDA approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz
· In the first quarter of 2019, Momenta recorded $2.4 million in product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)
· In November 2018, the Company announced license agreements with AbbVie, providing worldwide rights for the launch of M923. Under the terms of the agreements, and subject to approval by health regulatory authorities, Momenta may launch M923 worldwide based on agreed-to launch dates, including in the U.S. in November 2023. Momenta is currently seeking a commercialization partner for this product.
M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan
· Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and Immunogenicity of M710 with EYLEA.
· In January 2019, Momenta’s formal notice of termination for all other biosimilar candidates previously subject to the collaboration agreement with Mylan became effective.
First Quarter 2019 Financial Results
Revenue: In the first quarter of 2019, the Company recorded $2.4 million in product revenue from Sandoz’s sales of Glatopa, net of a deduction of $1.5 million for legal settlement and royalty payments to Teva Pharmaceutical Industries. In the first quarter of 2018, the Company recorded $3.5 million in product revenue, net a deduction of $9.8 million for 50% of Glatopa 40 mg/mL inventory reserved by Sandoz. The decrease in product revenue from the prior year period was primarily due to continued competition.
Research and development revenue for the first quarter of 2019 was $1.8 million, compared to $1.3 million in the same quarter in 2018. The increase in research and development revenue of $0.5 million, or 38%, was primarily due to higher revenue recognized on the collaborative upfront payment from Mylan of $0.6 million, offset in part by lower reimbursement revenue for Glatopa expenses of $0.2 million.
Total revenue for the first quarter of 2019 was $4.1 million compared to $4.9 million for the same period in 2018.
Operating Expenses: Total GAAP operating expenses were $52.2 million in the first quarter of 2019.
Research and development expenses for the first quarter of 2019 were $28.0 million, compared to $33.2 million for the same period in 2018. The decrease of $5.2 million, or 16%, was primarily due to cost savings following our workforce reduction in the fourth quarter of 2018 and lower lease costs, offset by increased costs related to our M281 clinical trials.
General and administrative expenses for the first quarter of 2019 were $24.2 million, compared to $20.6 million for the same period in 2018. The increase of $3.6 million, or 17%, was primarily driven by depreciation and legal costs, offset by savings in costs following our workforce reduction in the fourth quarter of 2018.
First quarter 2019 non-GAAP operating expense was $48.3 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.
Net Income (Loss): The Company reported a net loss of $44.8 million, or $0.46 per share for the first quarter of 2019 compared to a net loss of $47.6 million, or $0.63 per share, for the same period in 2018.
Cash Position: At March 31, 2019, Momenta had $416.5 million in cash, cash equivalents and marketable securities compared to $449.4 million at December 31, 2018.
2019 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 financial measures. 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, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. Momenta re-affirms its quarterly non-GAAP operating expense guidance of $45 – $55 million for 2019.
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 as it excludes non-cash stock compensation expense, restructuring expense and collaborative reimbursement revenue. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly 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 estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled "2019 Financial Guidance."
Conference Call Information
Management will host a conference call and webcast today at 8:30 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 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 8949569. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 8949569. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7484068.