Momenta Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results
-- Ended 2018 with a cash position of
-- Phase 2 trials of M281 in myasthenia gravis (MG) and hemolytic disease of the fetus and newborn (HDFN) underway; First healthy volunteer dosed in Phase 1/2 trial of M254 in immune thrombocytopenia (ITP) --
“In 2018 we transformed our company to focus on discovering and developing new therapies to treat rare immune-mediated disorders. We have since made important progress, as we have commenced two Phase 2 clinical trials of our anti-FcRn antibody, M281, and dosed the first healthy volunteer in part 1 of a Phase 1 / 2 clinical trial of our hypersialylated IgG candidate M254. Meanwhile, our legacy business continues to provide value in the form of revenue from the Glatopa franchise and we continue to work with Mylan to advance the Phase 3 clinical trial of M710, our biosimilar EYLEA candidate,” said
“Looking forward, as we focus on operational execution in the year ahead, we remain confident in the ability of our differentiated platforms to produce best-in-class immune-mediated therapeutics and are well-capitalized to execute on our development plans,” Wheeler continued.
Fourth Quarter 2018 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)
- The Company has commenced two Phase 2 clinical studies of M281 in gMG and HDFN with topline results anticipated in 2020 and 2021, respectively. The Company also plans to initiate a third study of M281 in an additional autoimmune indication in 2019.
February 2019, the Company presented research at the Society for Maternal-Fetal Medicine39th Annual Pregnancy Meeting in Las Vegas, NVhighlighting the ability of M281 to inhibit transfer of immunoglobulin G from maternal to fetal circulation in an ex vivo placental perfusion model.
November 2018, the Company announced the publication of results from a Phase 1 clinical trial of M281 in healthy volunteers in the peer-reviewed journal Clinical Pharmacology & Therapeutics.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
January 2019, the Company announced that the first subject was dosed in the Phase 1/2 clinical trial in ITP. The multi-part study will first enroll healthy volunteers and includes single and multiple dose studies, and a randomized cross-over study comparing M254 to IVIg. 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.
Glatopa® 20 mg and 40 mg:
- In the fourth quarter of 2018, Momenta recorded
$10.8 millionin product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to HUMIRA® (adalimumab)
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 United States(U.S.) in November 2023.
M710: a proposed biosimilar to EYLEA® (aflibercept) candidate being developed in collaboration with Mylan
August 2018, Mylan initiated a pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. In November 2018, Momenta provided formal notice of termination for all other biosimilar candidates previously subject to the collaboration agreement with Mylan.
December 2018, Momenta announced the closing of a public offering of 20.0 million shares of its common stock at the price of $11.50per share. Aggregate gross proceeds from the offering were $230.0 million.
Fourth Quarter and Full Year 2018 Financial Results
Revenue: In the fourth quarter of 2018, the Company recorded
Research and development revenue for the fourth quarter of 2018 was
Total revenue for the fourth quarter of 2018 was
Operating Expenses: Total GAAP operating expenses were
Research and development expenses for the fourth quarter of 2018 were
General and administrative expenses for the fourth quarter of 2018 were
Fourth quarter non-GAAP operating expense was
Net Income (Loss): The Company reported a net loss of
Cash Position: At December 31, 2018, Momenta had
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 is providing quarterly non-GAAP operating expense guidance of
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
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 7484068. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 7484068. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7484068.
Momenta Pharmaceuticals is a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases and advancing its late stage biosimilars and is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
The Company’s logo, trademarks, and service marks are the property of
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 for clinical development and marketing approval; the timing of regulatory approval and launch of our product candidates; development timelines; the Company’s ability to meet its development and strategic goals; market potential and revenue of our products and product candidates, design, timing and goals of clinical trials and the availability, timing and announcement of data and results; the use, efficacy, safety, potency, tolerability, convenience and commercial potential of our product candidates, including their potential as best-in-class agents; future legal proceedings; expectations regarding accounting treatment for and recognition of consideration and revenue under the Company’s collaborations; reconciling information; non-GAAP operating expense guidance; and anticipated collaborative reimbursement revenue. Forward-looking statements may be identified by words and phrases such as "advance," "anticipate," 'being developed," "believe," "continue," "expect," "guidance," "look forward to," "may," "plan," "possible," "potential," "progress," "propose," "remains," "target," "will," "working toward" 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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.
|INVESTOR CONTACT:||MEDIA CONTACT:|
|Patty Eisenhaur||Karen Sharma|
|Momenta Pharmaceuticals||MacDougall Biomedical Communications|
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|December 31, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||449,411||$||379,890|
|Liabilities and Stockholders’ Equity|
|Deferred revenue, net of current portion||1,774||30,751|
|Other long-term liabilities||17,270||10,039|
|Total liabilities and stockholders’ equity||$||531,563||$||459,431|
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Operations and Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months Ended
|Research and development revenue||32,059||51,239||35,905||72,079|
|Total collaboration revenue||42,822||64,608||75,589||138,882|
|Research and development||28,695||36,148||124,004||149,226|
|General and administrative||21,525||15,827||85,105||82,207|
|Total operating expenses||52,492||51,975||256,916||231,433|
|Loss from operations||(9,670||)||12,633||(181,327||)||(92,551||)|
|Other income, net||1,426||1,126||5,266||4,455|
|Net income (loss)||$||(8,245||)||$||13,759||$||(176,061||)||$||(88,096||)|
|Earnings (net loss) per share:|
|Shares used in calculating net loss per share|
|Comprehensive income (loss)||$||(8,168||)||$||13,572||$||(176,008||)||$||(88,322||)|
|MOMENTA PHARMACEUTICALS, INC.|
|Reconciliation of GAAP Results to Non-GAAP Financial Measures|
|A reconciliation of historical GAAP operating expenses to Non-GAAP operating expenses is as follows:|
|Three Months Ended
|GAAP operating expenses||$||52,492||$||51,975||$||256,916||$||231,433|
|Non-cash stock compensation expense||(2,498||)||183||(17,414||)||(16,127||)|
|Collaboration expenses that are recorded as
revenue and are reimbursable by
|Non-GAAP operating expenses||$||47,203||$||51,635||$||219,227||$||208,242|
Source: Momenta Pharmaceuticals, Inc.