On November 2, 2016 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2016 (Press release, Momenta Pharmaceuticals, NOV 2, 2016, View Source [SID1234516200]).

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For the third quarter of 2016, the Company reported total revenues of $29.1 million, including $23.3 million in product revenues from Sandoz’s sale of Glatopa (glatiramer acetate injection). For the nine months ended September 30, 2016, the Company reported total revenues of $75.4 million, including $58.8 million of product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(17.5) million, or $(0.26) per share for the third quarter of 2016 compared to a net loss of $(30.1) million, or $(0.44) per share for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $(62.5) million, or $(0.91) per share compared to a net loss of $(54.1) million, or $(0.88) per share for the same period in 2015. At September 30, 2016, the Company had cash, cash equivalents, and marketable securities of $309.0 million compared to $336.9 million at June 30, 2016.

"Our biosimilars collaboration with Mylan continues to advance. Today we announced the initiation of a Phase 1 trial for our lead candidate, M834, a biosimilar version of ORENCIA. We also recently re-gained the rights to M923, our biosimilar HUMIRA candidate, and believe this is a real opportunity for us to generate additional value from this product," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Glatopa 20 mg sales continued to provide us with a healthy revenue stream, and we remain optimistic for the potential launch of our Glatopa 40 mg product candidate early next year."

Third Quarter Highlights and Recent Events

Complex Generics:

In the third quarter of 2016, Momenta recorded $23.3 million in product revenues from Sandoz’s Glatopa sales.
The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection) is under U.S. Food and Drug Administration (FDA) review. The Company expects to receive tentative regulatory approval in the next few months.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) concluded on October 6, 2016. The Company expects a decision to be issued in the first quarter of 2017.
Biosimilars:

Momenta and its collaboration partner Mylan reported the initiation of a Phase 1 clinical trial for M834, a biosimilar ORENCIA (abatacept) candidate. Under the Mylan collaboration agreement, Momenta achieved a regulatory milestone thereby earning a $25.0 million payment from Mylan. The companies plan to report top-line data from the trial by the end of 2017.
In September, the U.S. Patent and Trademark Office held a hearing in Inter Partes Review (IPR) proceedings for the Company’s challenge of the validity of Bristol Myers Squibb’s U.S. Patent No. 8,476,239 covering formulations of ORENCIA which is set to expire in 2028. The Patent Office’s decision is due by January 15, 2017.
In September, Momenta regained global development and commercialization rights to M923, a biosimilar HUMIRA (adalimumab) candidate. Shire exercised its right to terminate the collaboration agreement for M923 following its combination with Baxalta. Under the terms of the collaboration, the agreement will terminate twelve months following the notice, and Shire is obligated to fund the M923 program until termination. The Company plans to release top-line results from the Phase 3 clinical trial for M923 in late 2016, and the first regulatory submission for marketing approval is planned for mid-2017. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2018.
Novel Drugs for Autoimmune Indications:

Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company has initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects and expects to report data in the second half of 2017. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its novel drug candidates for autoimmune indications.

Corporate:

The Company announced today the appointment of Scott M. Storer as Senior Vice President and Chief Financial Officer effective November 28, 2016. Mr. Storer will replace Momenta’s current Chief Financial Officer, Rick Shea, who will be retiring. Mr. Storer will report directly to Craig Wheeler, Momenta’s President and Chief Executive Officer, and will serve as a member of the Executive Committee. Prior to joining Momenta, Mr. Storer was Senior Vice President, Finance at Baxalta, Inc. following its spin-out from Baxter International in July 2015. He joined Baxter in 1997 and previously held several positions, most recently serving as Vice President of BioScience Finance.

Third Quarter 2016 Financial Results

Total revenues for the third quarter of 2016 were $29.1 million compared to $13.8 million for the same period in 2015. Total revenues for the third quarter of 2016 include $23.3 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $8.7 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. The increase in product revenue was due to a higher number of Glatopa units sold in the 2016 period.

Collaborative research and development revenue for the third quarter of 2016 was $5.8 million compared to the $5.1 million recorded in the same quarter last year. The increase of $0.7 million, or 14%, from the 2015 period to the 2016 period was primarily due to $1.8 million of revenue recognized in the third quarter of 2016 from the amortization of the $45 million upfront payment under the Mylan collaboration agreement, offset by lower reimbursable expenses for M923. Collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire, were $1.5 million for the third quarter of 2016, compared to $2.7 million for the same period in 2015.

Research and development expenses for the third quarter of 2016 were $31.6 million, compared to $31.7 million for the same period in 2015. The decrease of $0.1 million from the 2015 period to the 2016 period was due to a decrease of $7.7 million for Mylan’s 50% share of biosimilar collaboration costs, offset primarily by increases of $3.2 million in process development costs for biosimilars under the Company’s collaboration with Mylan, $1.9 million in non-clinical expenses to advance the Company’s novel autoimmune programs and $1.8 million in necuparanib Phase 2 clinical trial costs due in part to the termination of the development program.

General and administrative expenses for the quarter ended September 30, 2016 were $15.8 million, compared with $12.5 million for the same period in 2015. The increase of $3.3 million, or 26%, was primarily due to increases of $1.4 million in personnel-related expenses due to growth in headcount, $1.5 million in legal and professional fees, $0.4 million in stock-based compensation primarily due to performance-based restricted stock awards granted in 2016 and $0.4 million in facilities expenses. These increases were offset by a decrease of $0.4 million for Mylan’s 50% share of biosimilar collaboration costs.

At September 30, 2016, Momenta had $309.0 million in cash, cash equivalents and marketable securities.

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.

Today, Momenta reiterated its non-GAAP operating expense guidance of approximately $40 – $45 million for the fourth quarter of 2016. Non-GAAP operating expense is total operating expenses (which is net of Mylan’s share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire. The quarterly recognition of collaborative revenues under the Company’s collaboration with Mylan is expected to be $1.8 million per quarter. Under the collaboration with Baxalta, the Company expects to recognize collaborative revenues of approximately $3.7 million per quarter for the next three quarters and approximately $3.5 million in the third quarter of 2017 representing the remaining balance of deferred revenue.