On May 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the first quarter ended March 31, 2018 (Press release, Perrigo Company, MAY 8, 2018, View Source [SID1234526186]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Additional first quarter reported results: Reported operating margin in the CHC Americas segment was 18.8%.

Perrigo President and CEO, Uwe Roehrhoff commented, "Our unique business model once again delivered results in challenging end markets evidenced by year-over-year first quarter adjusted net income growth of 18.8% and adjusted diluted EPS growth of 20.6%. The CHC Americas team drove net sales growth of 3.0% on a constant currency basis with adjusted operating margin of 21.4% highlighted by a relatively strong cough cold season in the U.S. Net sales in the CHC International segment grew 1.4% on an organic constant currency basis, excluding $22 million in net sales from the exited Russian and unprofitable distribution businesses in 2017, and achieved strong operating results. Our RX Pharmaceuticals ("RX") segment continues to perform in a challenging market. First quarter net sales in RX were slightly lower than the prior year and adjusted operating margin was 39.9% as R&D investments increased versus last year. Finally, our durable platforms once again delivered strong cash flow conversion to adjusted net income, which we utilized to repurchase approximately 1.3 million shares in the quarter."

Mr. Roehrhoff continued, "We remain focused on delivering our consolidated 2018 net sales and adjusted EPS guidance ranges previously communicated. Our consumer-facing businesses are on track to meet their financial goals amid soft consumer trends and we have increased our adjusted operating margin expectation in the CHC International segment due to ongoing operational initiatives. Balanced against this increase, we have adjusted our expectations for the RX segment due primarily to a supply disruption of a key new product, which we are working to bring back to market in the fourth quarter of this year. We are making progress with our value creation roadmap and look forward to discussing the conclusions later this year."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the first quarter of calendar year 2018 were $1.2 billion, which included new product sales of $41 million and discontinued products of $8 million. Net sales grew 1.6% compared to the prior year excluding the year-over-year effect of: 1) $22 million in net sales from the exited Russian and unprofitable distribution businesses in 2017 in the CHC International segment, 2) net sales from the divested Israel API business of $19 million, and 3) favorable foreign currency movements of $45 million.

Reported net income was $81 million, or $0.57 per diluted share versus net income of $72 million, or $0.50 per diluted share, in the prior year. Excluding charges as outlined in Table I, first quarter 2018 adjusted net income was $178 million, or $1.26 per diluted share, versus adjusted net income of $150 million, or $1.05 per diluted share, for the same period last year.

First quarter net sales grew 3.0% on a constant currency basis, driven by higher net sales in the infant nutrition, analgesics and cough cold categories compared to the prior year. These positive drivers, and new product sales of $11 million, were partially offset by lower net sales in the animal health category and discontinued products of $2 million.

The CHCA segment first quarter reported gross profit margin was 33.3%. Adjusted gross profit margin was 35.1%, 60 basis points higher than the prior year driven by stronger volumes in the quarter.

Reported first quarter operating margin was 18.8%. First quarter adjusted operating margin was 21.4%, 120 bps greater than the prior year due to gross margin flow through and lower operating expenses as a percentage to net sales.

Reported net sales increased 7.0% compared to the first quarter of 2017. Excluding $22 million in net sales from the exited Russian and unprofitable distribution businesses in 2017, and favorable foreign currency movements of $43 million, net sales grew 1.4% driven by new product sales of $20 million. Partially offsetting these favorable effects were lower net sales in the cough cold, personal care and analgesics categories in addition to discontinued products of $6 million.

First quarter reported gross margin was a strong 48.5%. Adjusted gross margin increased 350 bps over the previous year to a record 54.2%, driven by improved product mix, new product launches and the continued benefit of insourcing initiatives.

Reported operating margin was 3.7%. Adjusted operating margin expanded 320 bps to 17.0% due to higher gross margin contribution and the timing of growth investments.

Reported net sales in the first quarter were $214 million compared to $217 million last year. New product sales of $10 million were offset by lower net sales of existing products of $12 million, due primarily to price erosion, which was in line with expectations. New product sales were lower than expected due to a supply disruption of a key new product.

Reported gross margin was 45.7%. Adjusted gross margin was 55.3%, 90 bps higher than the previous year driven by product mix.

Reported operating margin was 28.9%. Adjusted operating margin was 39.9% compared to 41.0% in the prior year, due primarily to increased R&D investments.

Corporate Governance

The Perrigo Board of Directors appointed Rolf A. Classon, who has served on Perrigo’s Board since May 2017, as Chairman of the Board, effective May 7, 2018. Laurie Brlas, who has been on the Board since 2003 and has served as Chairman for the last two years, will continue to serve on the Board as an independent director and was appointed as a member of the Audit Committee.

Commenting on his appointment, Mr. Classon said, "I am both excited and humbled for the opportunity to lead Perrigo’s experienced Board. Perrigo’s unique business model, which provides healthcare solutions to patients and families, enables us to execute against our goal of generating value for our shareholders. On behalf of the entire Board and management team, I would like to thank Laurie for her service and guidance as Chairman. Her leadership contributions have been instrumental in focusing the organization on operational excellence, and I look forward to continuing to work alongside her."

Ms. Brlas commented, "I would like to congratulate Rolf on his appointment as Chairman of the Board. This appointment demonstrates good corporate governance and our commitment to shareholder value. I look forward to continuing to work with Rolf and the rest of the Board and leadership team."

Mr. Classon’s previous leadership experience included roles at Hillenbrand Industries, Bayer Healthcare AG, Bayer Diagnostics and Pharmacia Corporation. In addition to extensive experience in varying roles within the pharmaceutical industry, Mr. Classon also currently serves as a director of the boards of Fresenius Medical Care AG and Co and Catalent, Inc.

Guidance

The Company expects calendar year 2018 reported operating income to be in the range of $669 million to $729 million, reported effective tax rate to be approximately 21.3%, and reported diluted EPS to be in the range of $2.90 to $3.30.

The Company reconfirms calendar year 2018 net sales range of $5.0 billion to $5.1 billion, adjusted operating income range of $1.03 billion to $1.09 billion, adjusted effective tax rate of approximately 20.5% and adjusted diluted EPS range of $5.05 to $5.45.

The Company now expects calendar year 2018 net sales for the CHC International segment to be approximately $1.59 billion with an adjusted operating margin of approximately 15.5%. Net sales in the RX segment are now expected to be approximately $1.03 billion with an adjusted operating margin of approximately 40.0%.

Conference Call

The Company will host a conference call at 8:30 a.m. EDT (5:30 a.m. PDT), May 8, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 877-248-9413, International 973-582-2737, and reference ID #6366917. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Tuesday, May 8, until midnight Friday, May 18, 2018. To listen to the replay, dial 800-585-8367, International 404-537-3406, and use access code 6366917.

On May 8, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that it will be attending and presenting at the 19th Annual Bio€quity Europe Conference being held on May 14 – 16, 2018 at the Het Pand Convention Center in Ghent, Belgium (Press release, Actinium Pharmaceuticals, MAY 8, 2018, View Source [SID1234526223]). Details of Actinium’s presentation are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Date: Tuesday, May 15, 2018
Time: 4:20 p.m. CEST
Room: Level 1+, Priorzaal Room
Venue: The Het Pand Convention Center

Management will conduct one-on-one meetings with investors during the conference. To arrange a meeting with Actinium, please contact, Steve O’Loughlin, Actinium’s Principal Financial Officer at [email protected].

About the 19th Annual Bio€quity Europe Conference

Bio€quity Europe pioneered the turf-neutral concept, creating an open door for all members of the financial community and business development and licensing professionals to do business with independently selected presenting companies.

Now celebrating its 19th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals. Delegates from 24 nations attended Bio€quity Europe last year in Paris. To learn more, please click this link.

On May 8, 2018 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended March 31, 2018, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for 2018 (Press release, Clovis Oncology, MAY 8, 2018, View Source [SID1234526239]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We were very pleased to receive the expanded maintenance treatment indication for Rubraca in the U.S. in early April, and while it is early days in the launch, we are receiving very positive feedback to the broader and earlier-line label from clinicians," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are well positioned now with a strong balance sheet and a robust clinical development program for Rubraca, initiating new Clovis-sponsored single-arm studies in ovarian and bladder cancers with Opdivo by year-end, and looking forward to presenting initial data from TRITON2 in prostate cancer at ESMO (Free ESMO Whitepaper) in October. Finally, we are enthusiastic about initiating a global clinical development program for lucitanib, including multiple combination studies."

First Quarter 2018 Financial Results

Clovis reported net product revenue for Rubraca of $18.5 million for the first quarter of 2018. During the first quarter, the supply of free drug distributed to eligible patients through the Rubraca patient assistance program was approximately 22 percent of overall commercial supply. This would have represented an additional $5.1 million in commercial value for the quarter. We expect the supply of free drug to remain at this percentage or slightly higher for the foreseeable future. Net product revenue for the quarter ended March 31, 2017 was $7.0 million, following the initial approval and launch of Rubraca in the treatment setting on December 19, 2016.

Clovis had $463.8 million in cash, cash equivalents and available-for-sale securities as of March 31, 2018. In April 2018, Clovis raised net proceeds of $94.0 million through an offering of 1.8 million shares of common stock and $292 million aggregate principal amount of 1.25% convertible senior notes due 2025. The net proceeds from these offerings were $386.0 million, after deducting underwriting discounts and commissions, and offering expenses.

Clovis reported a net loss for the first quarter of 2018 of $77.7 million, or ($1.54) per share. The net loss for the first quarter of 2017 was $58.5 million, or ($1.33) per share. Net loss for the first quarter of 2018 included share-based compensation expense of $11.9 million, compared to $8.9 million for the first quarter of 2017.

Cash used in operating activities was $100.6 million for the first quarter of 2018, compared with $80.4 million in the first quarter of 2017. This includes product supply costs of $31.5 million in the first quarter of 2018, compared to $18.2 million for the first quarter of 2017. Product supply costs will be approximately $44 million in the second quarter of 2018 and will be approximately $10 million for the remainder of 2018. These costs reflect Clovis’ plan to build additional inventory in advance of the transition to a new manufacturing facility for Rubraca. The Company will also incur final capital costs for the new manufacturing facility of approximately $8 million in late 2018 as well. Additionally, Clovis will make one-time milestone payments to Pfizer of $38 million in the second quarter of 2018 related to product approvals in December 2016 and April 2018 and potentially an additional $20 million milestone payment in the second quarter if the Rubraca Marketing Authorization in Europe is granted prior to June 15, 2018.

Clovis had approximately 50.7 million shares of common stock outstanding as of March 31, 2018.

Research and development expenses totaled $43.5 million for the first quarter of 2018, compared to $32.4 million for the first quarter 2017. Research and development expenses will continue to increase compared to last year as planned Rubraca studies progress.

Selling, general and administrative expenses totaled $39.3 million for the first quarter of 2018, compared to $29.2 million for the first quarter in 2017. Selling, general and administrative expenses will continue to increase compared to last year in support of commercial activities related to Rubraca in the United States and Europe.

Key Milestones and Objectives for Rubraca

U.S. Approval for Ovarian Cancer Maintenance Treatment Indication

On April 6, the U.S. Food and Drug Administration (FDA) approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. In addition to granting Rubraca approval in this second indication, the FDA converted the approval of the initial treatment indication from an accelerated to a regular approval.

European Union (EU) Treatment Approval Anticipated in Q2 2018

In late March, the Company announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Clovis continues to anticipate the grant of the Marketing Authorization by the European Commission to follow in Q2 2018, and plans to submit a variation to the Marketing Authorization for the maintenance treatment indication, with the CHMP opinion for maintenance anticipated by the end of 2018. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.

Also during the quarter, the Company initiated an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who has received at least two prior platinum-based treatment regimens, has platinum-sensitive disease, and is in a complete or partial response to the most recent platinum-based regimen. In all cases, the patient must have a special clinical need that cannot be met by current licensed available medicines. Patients must be ineligible for Clovis’ ARIEL4 clinical trial or unable to access a participating ARIEL4 site to qualify for Clovis’ early access program. Questions or inquiries regarding the RAP should be directed to [email protected].

Rubraca Clinical Development

Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following clinical studies are open for enrollment or are anticipated to open during the next several months:

The Clovis-sponsored ARIEL4 confirmatory study in the treatment setting is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. This study, as part of a broad clinical collaboration with Bristol-Myers Squibb, is expected to begin in the first half of 2018.
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in mCRPC enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on AR-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting is also open for enrollment. TRITON3 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study enrolling patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy. This study is currently enrolling patients. The Company plans to present initial data from the ongoing TRITON2 study at ESMO (Free ESMO Whitepaper) in October 2018, pending abstract acceptance.
A Clovis-sponsored single-arm Phase 2 open-label monotherapy study of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. This study is currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, initiated during the quarter with the first patient dosed with rucaparib in Japan. The Phase 1 study seeks to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies.
A Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed, BRCA wild-type ovarian cancer and in patients with locally advanced or metastatic bladder carcinoma who are ineligible for treatment with cisplatin. This study is sponsored by Clovis and is expected to begin in the second half of 2018.
The Phase 3 pivotal study in advanced triple-negative breast cancer (TNBC) to evaluate Opdivo and Rubraca in combination. This study is sponsored by Bristol-Myers Squibb.
The Phase 2 combination study of Opdivo with Rubraca for the treatment of mCRPC. This study, sponsored by Bristol-Myers Squibb, is being conducted as an arm of a larger sponsored prostate cancer study. This study is currently enrolling patients.
The Phase 1b combination study of the cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and triple-negative breast cancers. This study is sponsored by Roche and is currently enrolling patients.
Exploratory studies in other tumor types are also underway.

Lucitanib Clinical Development

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFR α/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3), which was previously evaluated in breast and lung cancers in partnership with Servier. Clovis has received notice from Servier that they will return their ex-US rights (excluding China) for lucitanib later in 2018. Clovis therefore will own global rights (excluding China) to lucitanib. There are no payments from Clovis to Servier related to the return of these ex-US rights.

Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; data in breast and lung cancer were insufficient to move the program forward. Recent data for a similar drug that inhibits these same three pathways – when combined with a PD-1 inhibitor – are extremely encouraging and represent a validated and alternative hypothesis for the development of lucitanib in combination with a PD(L)-1 inhibitor, and a Clovis-sponsored combination study is now being planned. Clovis also intends to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate before the end of Q1 2019.

Conference Call Details

Clovis will hold a conference call to discuss Q1 2018 results this afternoon, May 8, at 4:30pm ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 4198438.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S.

On May 8, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that it was granted a patent from the United States Patent and Trademark Office (USPTO) for the methods of use of sd-rxRNAs targeting Connective Tissue Growth Factor (CTGF) for the treatment or prevention of fibrotic disorders, including skin fibrosis (USPTO Patent #: 9,963,702 B2) (Press release, RXi Pharmaceuticals, MAY 8, 2018, View Source [SID1234526255]). This patent includes RXI-109 and its use in dermal scarring, for which the safety and efficacy was shown in a recent Phase 2 clinical trial with statistically significant outcomes for improved visual appearance for RXI-109 treated scar over control. The patent is set to expire in 2031.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Robust clinical data and strong IP are key elements to successful pharmaceutical development and commercialization," said Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals. He added that, "Additional data on the results of our recent clinical study with RXI-109 in dermal scarring will be presented next week at the International Investigative Dermatology Conference. These data, in combination with the granting of this patent, supports RXi’s ongoing discussions with potential partners for our Dermatology Franchise, including RXI-109."

About RXi’s Dermatology Franchise

RXi announced in January 2018 that it would exclusively focus on developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi therapeutic platform. As such, it is actively seeking to partner or out-license both its Dermatology and Ophthalmology Franchises.

Each of these Franchises is comprised of a number of preclinical and clinical-stage assets broadly covered by a robust intellectual property estate. To obtain more information about these assets, contact RXi’s Director of Business Development, Dr. James Cardia at [email protected]

On May 8, 2018 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) reported its financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, Momenta Pharmaceuticals, MAY 8, 2018, View Source [SID1234526273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made important progress in the first quarter of 2018 across our complex generic, biosimilar and novel drug portfolios. Importantly, Glatopa 40 mg/mL received FDA approval and, with Sandoz’s commercial launch now underway, we look forward to the potential for accelerated adoption by customers as the year progresses. In addition, we are looking forward to the start-up of the pivotal patient trial for M710, our proposed biosimilar to EYLEA being developed in collaboration with Mylan, in the first half of 2018," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Our novel drug portfolio targeted at rare autoimmune indications also continues to advance. Earlier this year, we announced positive topline data from the Phase 1 study of M281, our potentially best-in-class anti-FcRn candidate; and CSL’s initiation of a Phase 1 study of M230, our potential first-in-class recombinant Fc multimer. M254, our hyper-sialylated IVIg, also remains on track to enter a Phase 1 study this year."

Wheeler continued, "The strategic review of our business announced earlier this year is active and we are evaluating options for our business including the potential for new partnerships across the portfolio or the sale of one or more of our biosimilar assets. We expect to complete this strategic review by the end of the second quarter of 2018."

First Quarter Highlights and Recent Events

Complex Generics:

Glatopa Products: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg/mL and daily COPAXONE 20 mg/mL (glatiramer acetate injection)

for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

On February 13, 2018, Momenta announced that the FDA had approved Sandoz’s Abbreviated New Drug Application for Glatopa 40 mg/mL and that Sandoz initiated the launch of the product in the US. Sandoz has secured customer contracts and orders of Glatopa 40 mg/mL have been shipped. Sandoz had to build inventory of Glatopa 40 mg/mL for the US launch and expects accelerated adoption by customers as the year progresses.

In the first quarter of 2018, Momenta recorded $3.5 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products, reflecting $13.3 million in profit share, net a deduction of $9.8 million in the first quarter of 2018 for 50% of Glatopa 40 mg/mL inventory reserves.

Enoxaparin Sodium Injection: First FDA-approved, substitutable generic LOVENOX (Enoxaparin Sodium Injection) used for the prevention and treatment of deep vein thrombosis developed in collaboration with Sandoz

On March 20, 2018, the US District Court of Massachusetts issued its final judgment affirming its February 2018 decision in the Company’s patent litigation against Amphastar involving US Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX, finding that the Company’s ‘886 patent was infringed by two separate methods used by Amphastar, but invalid for lack of written description and enablement. Momenta and Sandoz have appealed the case to the Court of Appeals for the Federal Circuit. Amphastar has moved to seek damages under the bond posted in connection with the preliminary injunction granted in 2010. Momenta and Sandoz have opposed the motion as premature pending a final ruling on appeal.

On March 20, 2018, the US District Court of Massachusetts also denied Momenta and Sandoz’s motion to dismiss Amphastar’s antitrust lawsuit. A trial is scheduled for September 2019. Momenta has filed a motion to certify the denial of the motion to dismiss as eligible for interlocutory appeal on the grounds that dismissal is warranted under law and an appeal at this time could resolve the case.

Biosimilars:

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

In January 2018, the Company announced that the Biologics License Application (BLA) for M923 is prepared to be filed with the FDA. The timing of Momenta’s filing of the BLA is dependent on the outcome of the Company’s ongoing strategic review.

M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan

In late 2017, Momenta announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to investigate these results in order to determine the next steps for the program.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

In January 2018, Momenta and Mylan disclosed that M710 is a proposed biosimilar to EYLEA and announced IND acceptance by the FDA. The companies plan to start-up the pivotal clinical trial in patients in the first half of 2018.

Novel Drugs for Rare Autoimmune and Immune-mediated Diseases:

M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

In January 2018, the Company reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.

Momenta is finalizing its development strategy for M281 and is planning two proof of concept clinical trials in the second half of 2018, pending regulatory feedback.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

In late January 2018, CSL began dosing subjects in the Phase 1 trial in healthy volunteers to evaluate the safety and tolerability of M230. The Phase 1 study is targeted to be completed in 2019.

M254 (hsIVIg): a hyper-sialylated immunoglobulin designed to be a higher potency alternative to intravenous immunoglobulin (IVIg) with the potential for enhanced safety and convenience

The Company is on track to complete the IND-enabling toxicology study this year and is targeting the initiation of a clinical trial in the second half of 2018.

First Quarter 2018 Financial Results

Revenue: In the first quarter of 2018, the Company recorded $3.5 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products reflecting $13.3 million in profit share, net a deduction of $9.8 million for 50% of Glatopa 40 mg/mL

inventory reserved by Sandoz, compared to $23.4 million in profit share from Sandoz sales of Glatopa 20 mg/mL for the same period in 2017. The decrease in product revenues of $19.9 million, or 85%, was primarily due to lower net sales driven by market decline, Mylan N.V.’s entry into the COPAXONE market, and Glatopa 40 mg/mL pre-launch inventory reserves.

Research and development revenue for the first quarter of 2018 was $1.3 million compared to $3.2 million recorded in the same quarter last year. The decrease in research and development revenue of $1.9 million, or 59%, was primarily due to lower revenue recognized from the Mylan upfront payment as compared to the amount recognized in the 2017 period and lower reimbursable expenses for the Company’s complex generic programs.

Total revenues for the first quarter of 2018 were $4.9 million compared to $26.6 million for the same period in 2017.

Operating Expenses: Total GAAP operating expenses were $53.9 million in the first quarter of 2018.

Research and development expenses for the first quarter of 2018 were $33.2 million, compared to $36.1 million for the same period in 2017. The decrease of $2.9 million, or 8%, was primarily due to a decrease in external R&D expenses for M923 offset by increases in spending for M710 and M281.

General and administrative expenses for the first quarter of 2018 were $20.6 million, compared with $23.1 million for the same period in 2017. The decrease of $2.5 million, or 11%, was primarily driven by lower legal expenses related to the Company’s litigation.

First quarter non-GAAP operating expense was $48.4 million, within the range of previously provided guidance of $45 – $55 million. Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. 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 Loss: The Company reported a net loss of $47.6 million, or $0.63 per share for the first quarter of 2018 compared to a net loss of $31.8 million, or $0.46 per share for the same period in 2017.

Cash Position: At March 31, 2018, Momenta had $346.0 million in cash, cash equivalents and marketable securities compared to $379.9 million at December 31, 2017.

2018 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 expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. Today, Momenta is reiterating non-GAAP operating expense guidance of approximately $180 – $220 million for 2018 and $45 – $55 million for the second quarter of 2018. The Company expects to continue to recognize revenue from Mylan’s $45 million upfront payment on a quarterly basis. The Company also estimates that collaborative reimbursement revenues will be approximately $0 – $2 million per quarter in 2018. The Company’s guidance for 2018 is subject to potential changes in operating plans based on the outcome of the strategic review.

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 and collaborative reimbursement revenues. 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 "2018 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 8:00 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.

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 7665388. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 7665388. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7665388.