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Ipsen delivers strong 2016 results and expects further sales growth and margin enhancement for 2017

oN February 23, 2017 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, reported financial results for the full year 2016.

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Commenting on the 2016 full year performance, David Meek, Chief Executive Officer of Ipsen, said: "The strong operating performance in 2016 serves as a solid foundation for the company in this new era of accelerated momentum and transformation. Sales grew by nearly 12% year-on-year, a record high for Ipsen, and core operating margin improved despite additional investments for the Cabometyx launch in Europe."

David Meek added: "2016 was a very productive year for Ipsen with the Cabometyx approval and launch for second line renal cell carcinoma in Europe, the launch of new indications for Dysport in the U.S., a new corporate governance structure implemented, and most recently, the acquisition of Onivyde, which reinforces our specialty oncology strategy. The focus for 2017 will be on building upon the strong momentum of the current business and the successful launch of Cabometyx, which combined with the expected addition of Onivyde and the new Primary Care products, will significantly contribute to the growth and profitability of the company in the coming years."

New definition of Core Financial Measures

Ipsen has updated its definition of Core financial measures (Core Operating income, Core consolidated net profit, Core EPS) to exclude the amortization of intangible assets (excluding software) and the gain or loss on disposal of fixed assets.

Core financial measures are the key performance indicators for understanding and measuring the performance of the Group. Ipsen believes that the updated financial indicators reflect with better clarity the Group’s underlying business trends and enable more meaningful comparisons year on year, as they exclude non-core items which may vary significantly.

These performance indicators do not replace IFRS indicators, and should not be relied upon as such.

Reconciliations between IFRS 2015/2016 results and the newly defined Core financial measures are presented in Appendix 4 and in the "Reconciliation from Core consolidated net profit to IFRS consolidated net profit" table on page 12.

Review of the full year 2016 results

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.

In 2016, Group sales reached €1,584.6 million, up 11.8% year-on-year.

Specialty Care sales reached €1,273.0 million, up 16.1%, driven by the strong growth of Somatuline in North America, as well as a solid performance throughout Europe.

Dysport good sales performance in aesthetics in the U.S. through Galderma, and in Russia and the Middle East was offset by importation issues in Brazil that occurred in the second half of the year due to a temporary cancellation of the certificate of Good Manufacturing Practices (cGMP). Decapeptyl sales reflect good volume growth in Europe and China offset by price pressure in the region. The Group booked during the fourth quarter the first sales of Cabometyx in Europe, mainly in Germany, Austria and France following the product approval by EMA in September.

Primary Care sales reached €311.6 million, down 2.7%, impacted by lower sales in Russia for Tanakan and other Primary Care products, while Smecta sales were slightly up driven by the implementation of the new OTx6 commercial model.

Core Operating Income totaled €363.9 million, up 11.1%. Core operating margin reached 23.0%, up 0.3 points compared to 2015, mainly driven by strong business performance, partially offset by investments for the Cabometyx launch and the adverse impact of foreign currencies.

Core consolidated net profit was €263.6 million, up 12.8% over the period, compared to €233.8 million in 2015.

Core earnings per share – fully diluted (see Appendix 4) grew by 13.0% year-on-year to reach €3.18 for 2016, compared to €2.82 in 2015.

Free cash flow generated in 2016 reached €228.8 million, up by €52.5 million, driven by the strong operating performance and a good management of working capital and capital expenditures.

Closing net cash reached €68.6 million at the end of the period, compared to €186.9 million in 2015, notably after payments to Exelixis for the original cabozantinib license and subsequent extension to Canada, as well as regulatory and commercial milestones, for a total of €257.3 million in 2016.

IFRS Operating Income totaled €304.7 million, up 24.8% from €244.0 million in 2015, impacted by lower impairment charge, with an Operating margin at 19.2%, up 2.3 points compared to 2015.

IFRS Consolidated net profit was €226.6 million, up 18.8% over the period, compared to €190.7 million in 2015 and fully diluted EPS at €2.73 in 2016, was up 18.7% from €2.30 in 2015.

Comparison of 2016 performance with financial objectives

The Group exceeded the raised guidance provided on 26 October 2016 for Specialty Care sales and Core operating margin and came in at the favorable end of revised guidance for Primary Care sales.

The table below shows the comparison between the financial objectives provided on 26 October 2016 and 2016 actuals, both including the amortization of intangible assets.

Picture 2

Below is a reconciliation of the Core Operating Income from the previous definition to the new reported definition:

Picture 3

Dividend for the 2016 financial year proposed for the approval of Ipsen’s shareholders

The Ipsen S.A. Board of Directors, which met on 22 February 2017, has decided to propose at the annual shareholders’ meeting on 7 June 2017 the payment of a dividend of €0.85 per share, stable year-on-year.

2017 Financial objectives

The Group has set the following financial targets for 2017 assuming a successful closing of the Onivyde transaction with Merrimack by the end of the first quarter 2017, and of the Consumer Healthcare transaction with Sanofi in the second quarter of 2017:

Specialty Care sales growth year-on-year greater than +18.0%;
Primary Care sales growth year-on-year greater than +4.0%;
Core operating margin (excluding amortization of intangible assets) greater than 24% of net sales.
Sales objectives are set at constant currency.

CBT PHARMACEUTICALS PRESENTS DATA DEMONSTRATING ANTI-TUMOR ACTIVITY OF ITS PROGRAMMED DEATH-1 ANTIBODY, CBT-501, AT ASCO-SITC CLINICAL ONCOLOGY SYMPOSIUM

On February 23, 2017 CBT Pharmaceuticals, Inc. (CBT), a life sciences company focused on developing innovative oncology therapeutics, reported preclinical data demonstrating the efficacy of its Programmed Death-1 (PD-1) antibody, CBT-501 (genolimzumab, GB-226), in stimulating various immune cells, generating anti-tumor immunity, and suppressing tumor growth and delaying tumor progression in a preclinical model of colon cancer (Press release, CBT Pharmaceuticals, FEB 23, 2017, View Source [SID1234517818]). The data were presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, Florida. The symposium is focused on the latest clinical and translational research in immuno-oncology and the implications for clinical care.

"The strong in-vivo preclinical data suggest that CBT-501 may have clinical benefit in a variety of tumor types," said Sanjeev Redkar, Ph.D., Chief Executive Officer and President at CBT Pharmaceuticals. "CBT-501’s novel epitope, with overlapping yet distinct regions compared to incumbent PD-1 inhibitors, may offer a point of differentiation in the clinical setting."

Presentation Highlights:

CBT-501 efficiently inhibited binding of PD-L1/L2 to PD-1 through competitive action.
CBT-501 enhanced human T-cell activation, as shown by increased release of IL-2 and INF-gamma.
In a humanized preclinical model expressing human PD-1 and implanted with a colon adenocarcinoma (MC38) cell line, CBT-501 significantly inhibited tumor growth in a dose-dependent manner that was comparable or improved over nivolumab.
"These studies support our commitment to advancing the clinical development of genolimzumab (CBT-501) as an immuno-oncology therapy for many types of cancer. Based on these findings, a Phase 1 dose escalation and dose and disease expansion study will be initiated in the first half of 2017," said Gavin Choy, Pharm.D., Chief Operating Officer at CBT Pharmaceuticals.

Genolimzumab Injection (CBT-501)

CBT-501 is a novel humanized IgG4 monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to marketed anti-PD-1 antibodies and has a superior safety profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity. The antibody (GB226) has been developed by Genor BioPharma Co. Ltd., a Walvax Company, who owns development and commercialization rights in China. CBT Pharmaceuticals, Inc. retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a phase 1 trial will be initiated in China by Genor.

Zymeworks Submits ZW25 Phase 1 Clinical Study Findings Abstract for ASCO 2017

On February 23, 2017 Zymeworks Inc. ("Zymeworks"), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that it has submitted an abstract for the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting that contains preliminary Phase 1 data from the ZW25 Phase 1 clinical trial for treatment of HER2-expressing tumors (Press release, Zymeworks, FEB 23, 2017, View Source [SID1234517817]).

"Two of the three cohorts from the dose escalation portion of the ZW25 Phase 1 clinical trial have been fully enrolled and preliminary data has been received for those patients," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "ZW25 is being evaluated for safety, as well as preliminary anti-tumor activity, and we are pleased to have been able to compile these results and submit them for presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting."

The 2017 ASCO (Free ASCO Whitepaper) annual meeting will be held June 2nd through June 6th in Chicago, Illinois. The ASCO (Free ASCO Whitepaper) annual meeting brings together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies and ongoing developments in the field of oncology. Abstracts will be released to the public on May 17th at 5:00 P.M. EDT and made available on ASCO (Free ASCO Whitepaper)’s website.

About ZW25

ZW25 is Zymeworks’ lead product candidate currently being evaluated in an adaptive Phase 1 clinical trial in the United States, based on our Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models. We are developing ZW25 as a best-in-class HER2-targeting antibody intended as a treatment option for patients with any solid tumor that expresses HER2.

MabVax Therapeutics Announces FDA Authorization to Proceed with MVT-1075 in a Phase I Clinical Trial for the Treatment of Pancreatic Cancer

On February 23, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer (Press release, MabVax, FEB 23, 2017, View Source [SID1234517816]). MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) is the Company’s novel fully human antibody radioimmunotherapy (RIT). MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017. This is the third IND authorized by FDA in the last fourteen months by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

In November 2016, MabVax reported positive interim results from two phase I trials. The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating patients at three clinical sites. Patients continue to be recruited to establish the recommended phase II dose (RP2D). The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.

David Hansen, MabVax’s President and Chief Executive Officer, said, “We are executing on the development strategy we have outlined and we are excited to take this next step forward. We are expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent. We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers.”

Radius Health Reports Fourth Quarter and Full Year 2016 Financial and Operating Results

On February 23, 2017 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the fourth quarter and full year ended December 31, 2016, and provided a business update (Press release, Radius, FEB 23, 2017, View Source [SID1234517813]). As of December 31, 2016, Radius had $332.4 million in cash, cash equivalents and marketable securities.

"We continue to work closely with the U.S. Food and Drug Administration as we move towards the March 30, 2017 PDUFA for abaloparatide-SC for postmenopausal osteoporosis. Our highly experienced leadership is completing the build out of our commercial organization with seasoned talent who have demonstrated success across sales, marketing, reimbursement and distribution and are fully prepared to support a successful launch, pending favorable regulatory review," said Robert Ward, President and Chief Executive Officer of Radius. "2017 will be a major inflection point for Radius, as we evolve towards a commercial company. We are confident that we are prepared for this change and have the talent, experience and resources required to deliver sustainable high performance."

Pipeline Updates

Abaloparatide-SC

Radius’ new drug application (NDA) in the United States for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis was accepted for filing by the FDA and granted a Prescription Drug User Fee Act (PDUFA) date of March 30, 2017. Radius’ marketing authorisation application (MAA) to the European Medicines Agency (EMA), is currently undergoing regulatory review, and we anticipate receiving an opinion from the Committee for Medicinal Products for Human Use (CHMP) in 2017.

On February 1, 2017, results from the first six months of the recently completed 24- month ACTIVExtend trial were published in the Mayo Clinic Proceedings "Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial". The 24-month ACTIVExtend clinical trial has completed and Radius will report the top line results in the second quarter of 2017.

Abaloparatide-SC as a treatment for postmenopausal women with osteoporosis is an investigational product and its safety and efficacy have not been established.

Abaloparatide-TD

Last September, at the annual meeting of the American Association for Bone Mineral Research (ASBMR), we presented the positive results from a human replicative clinical evaluation of an optimized abaloparatide transdermal patch. These results established an important demonstration of how we have changed the pharmacokinetic profile in our program to develop a bioequivalent transdermal patch. Currently, we are focused on completing the manufacturing, scale-up, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to abaloparatide-SC. We believe that the transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, an opportunity to expand their practices to include the use of anabolic therapy.

RAD1901

On December 8, 2016, at the San Antonio Breast Cancer symposium we reported on the encouraging results of our ongoing Phase 1 studies of RAD1901 in advanced breast cancer. We were pleased with the clear demonstration of activity at the 400 mg dose in this heavily pretreated patient population. We plan to engage with regulatory agencies to gain alignment on defining the next steps for the program in the first half of 2017, which would include the design of a Phase 2 trial. Also in the first half of this year, we plan to report results from our completed Phase 2b trial in vasomotor symptoms.

RAD140

In December 2016, we submitted an investigational new drug application, or IND, to the FDA for RAD140, a selective androgen receptor modulator discovered in-house at Radius. We expect to initiate a first-in-human Phase 1 clinical trial in women with hormone receptor positive breast cancer in 2017.

Building A Commercial Organization For Sustainable Growth

In our evolution towards becoming a fully integrated biopharmaceutical company, our accomplished senior leadership is completing the build out of our commercial, medical and compliance organizations to support the potential commercialization of abaloparatide-SC in the United States, pending favorable regulatory review. Our sales leaders have already hired over 90% of our clinical sales specialists with a focus on identifying the most experienced team possible. The result is a sales team with substantial osteoporosis, injectable and women’s health experience, and the majority have had prior launch experience, which matches the depth of experience across our Medical Science Liaison team.

If approved, we intend to distribute abaloparatide-SC in the United States through a network of distributors and specialty pharmacies. Under this distribution model, both the distributors and specialty pharmacies would take physical delivery of product and the specialty pharmacies would dispense the product directly to patients.

Under the leadership of our Chief Compliance Officer, we are continuing to strengthen our compliance program in support of launch of abaloparatide-SC as part of our commitment to a strong culture of compliance and good corporate governance.

Radius Expects the Following Upcoming Milestones

Abaloparatide-SC
-FDA PDUFA date of March 30, 2017
-Receive a CHMP opinion regarding the EMA’s review of the abaloparatide-SC MAA in 2017
-Enter into a partnership for the potential commercialization of abaloparatide-SC prior to commercial launch
-Report top-line results from the recently completed 24-month ACTIVExtend clinical trial in the second quarter of 2017
RAD1901
-Complete ongoing Phase 1 breast cancer clinical trials
-Engage with regulatory authorities in 1H 2017 to gain alignment on defining next steps for the program, which would include the design of a Phase 2 breast cancer trial
-In 1H 2017, complete, and report results from, our ongoing Phase 2b vasomotor trial
RAD140
-Initiate a first-in-human Phase 1 study in 2017 in women with hormone receptor positive breast cancer
Radius Expects To Make Presentations at the Following Upcoming Conferences

On March 6, 2017, Radius President and CEO, Robert Ward will make a presentation and will host one-on-ones at the Cowen Conference in Boston
On March 24-25, 2017, at the 2017 World Congress of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), 4 scientific presentations will be made on abaloparatide titled:

-"Effects of abaloparatide-SC on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis"
-"Abaloparatide-SC decreases vertebral, nonvertebral, major osteoporotic, and wrist fractures in a subset of postmenopausal women at high risk of fracture by FRAX score"
-"Abaloparatide-SC for postmenopausal osteoporosis: analysis of the number needed to treat compared with teriparatide"
-"Abaloparatide-SC significantly reduces vertebral and nonvertebral fractures and increases bone mineral density regardless of baseline risk: results from the ACTIVE phase 3 clinical trial"
Fourth Quarter 2016 Financial Results

For the three months ended December 31, 2016, Radius reported a net loss of $52.7 million, or $1.22 per share, as compared to a net loss of $33.2 million, or $0.77 per share, for the three months ended December 31, 2015. The increase in net loss for the three months ended December 31, 2016 as compared to the three months ended December 31, 2015 was primarily due to an increase in research and development and general and administrative expenses, partially offset by a decrease in loss on retirement of note payable, a decrease in interest expense and an increase in interest income.

Research and development expenses for the three months ended December 31, 2016 were $25.6 million, compared to $22.2 million for the same period in 2015. This increase was primarily driven by higher research and development costs associated with the development of RAD1901 to support a Phase 1 study in metastatic breast cancer that commenced in late 2014 and a Phase 2b study in postmenopausal vasomotor symptoms that commenced in December 2015. This increase was also a result of an increase in compensation expense, including stock-based compensation, due to an increase in headcount from December 31, 2015 to December 31, 2016.

General and administrative expenses for the three months ended December 31, 2016 were $27.5 million, compared to $11.6 million for the same period in 2015. This increase was primarily attributable to an increase in professional support costs, including the costs associated with increasing headcount and preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review. This increase was also driven by an increase in compensation expense, including stock-based compensation, due to an increase in headcount from December 31, 2015 to December 31, 2016.

Full Year 2016 Financial Results

For the twelve months ended December 31, 2016, Radius reported a net loss of $182.8 million, or $4.24 per share, as compared to a net loss of $101.5 million, or $2.56 per share, for the twelve months ended December 31, 2015. The increase in net loss for 2016 was primarily due to an increase in research and development expenses and general and administrative expenses, partially offset by a decrease in loss on retirement of note payable, a decrease in interest expense and an increase in interest income.

Research and development expenses for the twelve months ended December 31, 2016 were $107.4 million, compared to $68.3 million for 2015. The increase was primarily attributable to increased compensation expense, including an increase of $3.3 million of non-cash stock-based compensation expense, due to growth in headcount from 48 research and development employees as of December 31, 2015, to 107 research and development employees as of December 31, 2016. This increase was also driven by higher contract service costs associated with the development of our investigational product candidate RAD1901 as a result of the increased clinical and manufacturing activities in 2016, as compared to 2015. These increases were partially offset by a decrease in the total professional contract service costs associated with the development of abaloparatide-SC as more subjects completed study protocol activities associated with the 24-month ACTIVExtend clinical trial in 2016, as compared to 2015.

General and administrative expenses for the twelve months ended December 31, 2016 were $77.5 million, compared to $30.8 million for 2015. This increase was primarily due to increased professional support costs of approximately $19.4 million, including costs associated with preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review, as compared to 2015. This increase was also driven by increased compensation expense, including an increase of $8.0 million of non-cash stock-based compensation expense, due to growth in headcount from 27 general and administrative employees as of December 31, 2015, to 130 general and administrative employees as of December 31, 2016.

For the twelve months ended December 31, 2016, the decrease in loss on retirement of note payable was $1.6 million and other expenses increased by $0.3 million. These amounts were partially offset by the increase in interest income from investments of $1.4 million and a decrease in interest expense of $1.9 million.

As of December 31, 2016, Radius had $332.4 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance, Radius believes that, prior to the consideration of revenue from the potential future sales, subject to favorable regulatory review, of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities for not less than twelve months from the date of this press release and into 2018.