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Ipsen Presents Its 2019 Results, Provides 2020 Guidance and Updates 2022 Financial Outlook

On February 12, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its financial results for the full year 2019 (Press release, Ipsen, FEB 12, 2020, View Source [SID1234554238]).

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Group sales growth of 15.8% as reported or 14.8% at constant currency and scope of consolidation1, driven by Specialty Care sales growth of 17.2%1, reflecting strong performance across all major products and geographies, while Consumer Healthcare sales were down -1.2%1
Core Operating margin at 30.4% of net sales, up 0.7 points. IFRS Operating margin at -1.3% of net sales, down 24.6 points
Setback in the palovarotene program of partial clinical hold for all patients under 14 years of age and reaching pre-specified second interim analysis futility criteria in the Phase 3 MOVE trial for fibrodysplasia ossificans progressiva (FOP), leading to a partial impairment of €669 million before tax
Core consolidated net profit of €563 million (+14.6% vs. 2018), with fully diluted Core EPS growing by 14.1% to reach €6.74. IFRS Consolidated net profit showing a loss of €50 million, with an IFRS net loss per share of €0.61
Sound financial structure, with a closing Net Debt of €1,116 million and a Net Debt to EBITDA ratio at 1.3x. Strong Free Cash Flow at €468 million, up 2%, mainly driven by higher Operating Cash Flow.
Continued commitment to disciplined execution of business development strategy for long-term sustainability focusing on the Group’s core therapeutic areas (Oncology, Neuroscience, Rare Diseases) and across different transaction structures and various phases of drug development
Advancing solid pipeline with several significant new chemical entities and Phase 3 / registrational trials, including the initiation of pivotal Phase 3 trials for Onivyde in 1L Pancreatic Ductal Adenocarcinoma (PDAC) and 2L Small Cell Lung Cancer (SCLC) and upcoming top-line results for the Phase 3 trial of Cabometyx in combination with nivolumab in 1L Renal Cell Carcinoma (RCC)
Proposed distribution of €1.00 per share2 for the 2019 financial year, consistent with the prior year
2020 guidance3 of Group sales growth greater than +6.0% at constant currency and Core Operating margin around 30.0% of net sales
Updated 2022 outlook3 with Group sales greater than €2.8 billion and Core Operating margin greater than 28.0% of net sales
Aymeric Le Chatelier, Chief Executive Officer and Chief Financial Officer of Ipsen, stated: "2019 was another excellent year of operating performance for Ipsen with continued double-digit top-line growth and core operating margin expansion. Despite the recent palovarotene setback, the fundamentals of our business remain strong with a growing Specialty Care franchise and a sound financial structure including attractive cash flow generation. We are committed to the disciplined execution of our strategy, delivering solid mid-single digit growth in 2020 and further advancing our R&D pipeline programs. We have also updated our 2022 outlook taking into account the latest developments in the current business. We remain focused on executing our internal and external R&D strategy to strengthen our pipeline and deliver sustainable growth for years to come."

_______________________

1 Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period. Sales [2]growth adjusted for consolidation scope including: subsidiaries involved in the partnership between Ipsen and Schwabe Group consolidated in accordance with the equity method since 1 January 2019; and 2018 Etiasa (mesalazine) sales adjusted for the new contractual set up.

2 Decided by the Ipsen S.A. Board of Directors, which met on 12 February 2020, to propose at the Annual Shareholders’ meeting on 2 May 2020.

3 Assuming no impact of new somatostatin analog (SSA) generic entry in 2020 and excluding impact of incremental investments in pipeline expansion initiatives

Review of full year 2019 results

Extract of audited consolidated results for the full year 2019 and 2018

(in million euros)

FY 2019

FY 2018

change

% change at

constant currency

and scope1

Group net sales

2,576.2

2,224.8

+15.8%

+14.8%

Specialty Care sales

2,299.4

1,924.5

+19.5%

+17.2%

Consumer Healthcare sales

276.8

300.3

-7.8%

-1.2%

CORE

Core Operating Income

782.6

659.9

+18.6%

Core Operating margin (as a % net sales)

30.4%

29.7%

+0.7 pts

Core consolidated net profit

563.4

491.6

+14.6%

Core EPS – fully diluted (€)

6.74

5.91

+14.1%

IFRS

Operating Income

(33.4)

519.4

-106.4%

Operating margin (as a % net sales)

-1.3%

23.3%

-24.6 pts

Consolidated net profit

(50.2)

389.1

-112.9%

EPS – fully diluted (€)

(0.61)

4.68

-113.0%

Group net sales reached €2,576.2 million, up 14.8%1 year-on-year.

Specialty Care sales reached €2,299.4 million, up 17.2%1, driven by the continued strong growth of Somatuline (lanreotide) and the €376.9 million contribution from the key Oncology launches of Cabometyx (cabozantinib) and Onivyde (irinotecan liposome injection). Somatuline growth of 18.3%1 was driven by continued positive momentum in North America (21.3%) and solid performance throughout Europe, including Germany. Dysport (botulinum toxin type A) growth was fueled by good performance in the therapeutics and in the aesthetics markets. Decapeptyl (triptorelin) sales reflect good volume growth across Major European countries and in Southeast Asia.

Consumer Healthcare sales reached €276.8 million, down -1.2%1, due to a decline in Smecta (diosmectite) sales, especially in China.

Core Operating Income reached €782.6 million in 2019, compared to €659.9 million in 2018, a growth of 18.6%, driven by the sales growth and after increased R&D investments to support the development of the growing pipeline.

Core Operating margin reached 30.4% of net sales, up 0.7 points compared to 2018.

Core consolidated net profit was €563.4 million in 2019, an increase of 14.6% versus €491.6 million in 2018, driven by higher Core Operating Income compensated by increased net financial costs, notably related to higher net debt from the Clementia acquisition.

Fully diluted Core earnings per share grew by 14.1% to reach €6.74, compared to €5.91 in 2018.

IFRS Operating Income was a loss of €33.4 million, mainly due to an impairment charge of €668.8 million on the intangible assets of palovarotene. IFRS operating margin of -1.3% was down 24.6 points compared to 2018.

IFRS Consolidated net profit was a loss of €50.2 million due to financial expenses resulting from the Onivyde contingent payment reevaluation, financing costs and income tax for a total of €244.8 million, offset by the positive impact on financial result of the revaluation of the Clementia Contingent Value Rights (CVR) and milestones, and on income tax of the tax effect from the palovarotene intangible asset impairment for a total of €220.0 million.

IFRS Fully diluted EPS (Earnings per share) was a net loss per share amounting to €0.61 versus a net profit of €4.68 in 2018.

Free Cash Flow reached €467.7 million, up by €9.3 million, mainly driven by higher Operating Cash Flow partly offset by higher cash out from restructuring costs, financial result and current income tax.

Closing net debt reached €1,115.6 million at the end of 2019, as compared to closing net debt in 2018 of €242.5 million. This reflects the acquisition of Clementia, other business development and milestones, the impact of the application of IFRS16, and the payment of the dividend.

Impairment loss related to palovarotene program

Ipsen recorded a €668.8 million partial impairment, before tax, on the palovarotene intangible assets at December 31, 2019 as a result of the recent developments in the palovarotene development program. This takes into account:

6 December 2019: Following discussions with the U.S. Food and Drug Administration (FDA), a partial clinical hold was issued for patients under the age of 14 for studies evaluating palovarotene for the chronic treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
24 January 2020: Palovarotene Phase 3 MOVE trial for fibrodysplasia ossificans progressiva (FOP) reached pre-specified second interim analysis futility criteria. Ipsen paused dosing patients in FOP trials taking into consideration IDMC’s recommendation to not discontinue trials based on encouraging therapeutic activity observed in preliminary post-hoc analyses.
Ipsen will continue the development of palovarotene, conduct further assessment of the MOVE dataset, address the FDA questions and define next steps for the clinical program to bring palovarotene to patients as quickly as possible.

Strategy update

During 2019, Ipsen made progress on its journey to being a leading global biopharmaceutical company focused on innovation and Specialty Care.

The three Specialty Care franchises all saw significant progress. The Oncology and Neuroscience franchises continued to demonstrate strong double-digit momentum and despite recent developments with palovarotene, Ipsen remains committed to building a successful Rare Diseases franchise and supporting patients living with FOP. In October 2019, Ipsen in-licensed BLU-782 from Blueprint Medicines, a highly selective ALK2 inhibitor in Phase 1 development for the treatment of FOP.

Ipsen is committed to continuing its business development strategy for long-term sustainability. The strategy will focus on the Group’s core therapeutic areas (Oncology, Neuroscience, Rare Diseases) and across different transactions structures and various phases of drug development. The disciplined execution of this strategy will be supported by the Group’s strong Free Cash Flow generation and close internal collaboration across Ipsen’s teams.

In 2020 and beyond, the Group’s mission to bring innovation to patients remains the same. The priorities and roadmap are clear, and Ipsen continues to execute against its objectives to maximize the portfolio while increasing the value of the pipeline.

Comparison of 2019 performance with financial objectives

The Group exceeded its upgraded guidance provided on 25 July 2019 as shown in the table below:

2019 Financial objectives

2019 Actuals

Group sales growth

(at constant exchange rate)

> +14.0%1

+14.8%1

Core Operating margin
(as a percentage of sales)

around 30.0%

30.4%

Distribution for the 2019 financial year proposed for the approval of Ipsen’s shareholders

The Ipsen S.A. Board of Directors, which met on 12 February 2020, decided to propose at the Annual Shareholders’ meeting on 29 May 2020 the distribution of €1.00 per share for the 2019 financial year, consistent with the prior year.

2020 Financial guidance

The Group has set the following financial targets for the current year, assuming no impact in 2020 of new somatostatin analog (SSA) generic entry:

■ Group sales growth year-on-year greater than +6.0% at constant currency; no impact of currency expected based on the current level of exchange rates.

■ Core Operating margin around 30.0% of net sales, excluding incremental investments in pipeline expansion initiatives.

Updated 2022 Outlook: The Group has updated its 2022 outlook taking into account the latest developments in its current business, mainly in the palovarotene development program:

– Group net sales greater than €2.8 billion, assuming current level of exchange rates;

– Core Operating margin greater than 28.0% of net sales

The outlook has been updated assuming no approval of additional meaningful products or indications (including no contribution from palovarotene), progressive entry of additional octreotide and lanreotide generics globally from 2021 and excluding the impact of incremental investments in pipeline expansion initiatives.

Conference call

Ipsen will hold a conference call Thursday, 13 February 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071 928 000

France and continental Europe: +33 (0) 1 76 70 07 94

UK: 08445 718 892

U.S.: (631) 510-7495

Conference ID: 8178467

A recording will be available for seven days on Ipsen’s website.

1 Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period. Sales growth adjusted for consolidation scope including: subsidiaries involved in the partnership between Ipsen and Schwabe Group consolidated in accordance with the equity method since 1 January 2019; and 2018 Etiasa (mesalazine) sales adjusted for the new contractual set up.

AmorChem Invests in Novel Approach to Target Myc-driven Cancers

On February 12, 2020 AmorChem II is proud to reported the financing of a collaboration centered around c-Myc, a proto-oncogene implicated in over 50% of all human cancers (, Amorchem, FEB 12, 2020, View Source [SID1234554237]). The venture capital fund is partnering with Univalor, the Montreal Clinical Research Institute ("IRCM") and McGill University in order to support the innovative work of the teams of Dr.Tarik Möröy and Dr. Nicolas Moitessier.

According to the World Health Organization, cancer is the second leading cause of death globally, responsible for an estimated 9.6 million deaths in 2018. The dysregulation of the oncoprotein c-Myc is a feature of many cancers, including medulloblastoma, colon cancer and leukemias. However, c-Myc is generally considered to be a challenging target because it lacks a druggable domain. In fact, despite the centrality of its role, none of the efforts to modulate c-Myc have shown clinical success to date.

"What attracted us to the project is the team’s unique proposal of targeting Miz-1, a c-Myc co-factor, which is critical for c-Myc’s ability to regulate cell cycle progression as well as apoptosis. We believe this is a very intriguing approach which also offers the potential of adding a promising small molecule strategy in the field of immunotherapy, through the emerging role of c-Myc in T-cell biology," says Kevin McBride, Partner and Chief Scientific Officer at AmorChem.

"Their participation at the 2019 AmorChem KNOCK OUTTM convinced us that the combination of Dr. Möröy’s work in biology and Dr. Moitessier’s work in medicinal and computational chemistry offered significant potential for solving the challenges presented by this target," explains Inès Holzbaur, Managing Partner at AmorChem.

"Beyond c-Myc, this program’s platform provides AmorChem a unique opportunity to develop a series of new drugs based on the potential druggability of POZ domains aimed, eventually, at other critical targets," adds Elizabeth Douville, Managing Partner at AmorChem.

"Participating in commercialized research such as this is a key goal for our University," said Sylvain Coulombe, Associate Vice-Principal, Innovation and Partnerships (I+P), McGill University. "Transforming world-leading research into innovation that saves lives is and will always be our priority, and this association brings us closer to that reality."

"The IRCM values collaboration and we are convinced of the benefits of bringing together the best experts around a project. We are therefore extremely pleased to receive the support of AmorChem for this promising collaborative project which aims to develop new therapeutic strategies for the future, "said Max Fehlmann, President and Scientific Director of the IRCM.

"Commercialising university research is not a simple task. It requires several stakeholders to agree on a common vision for the maturation of a project, and to work together toward de-risking innovation in order to create commercial value. The collaboration between the IRCM, McGill University, Univalor and AmorChem is a very good example of this kind of partnership. Through AmorChem’s financial support, it will be possible to validate the potential of the new platform developed by the team of Dr Möröy and Dr Moitessier", says Luc Paquet, President and CEO of Univalor.

AmorChem invests in a new approach to target cancers in which the c-Myc oncogene is deregulated

On February 12, 2020 AmorChem II is reported the funding of a new university project centered on c-Myc, a proto-oncogene involved in more than 50% of human cancers (Press release, Amorchem, FEB 12, 2020, View Source [SID1234554236]). The venture capital fund has signed an agreement with Univalor, the Montreal Clinical Research Institute ("IRCM") and McGill University to support the innovative work of the teams of Dr. Tarik Möröy and Dr. Nicolas Moitessier .

According to the World Health Organization, cancer is the second largest cause of death in the world. The dysregulation of the oncoprotein c-Myc is a characteristic found in many cancers, notably medulloblastoma, colon cancer and leukemias. However, c-Myc is difficult to target because it does not contain a domain that can easily be reached by a therapeutic molecule. To date, none of the strategies attempted to modulate this target has been clinically successful.

"We were attracted by the innovative approach proposed by the team, namely targeting Miz-1, a c-Myc cofactor essential for its ability to regulate cell cycle progression and apoptosis. This approach seemed very intriguing to us and offers the potential to add a small molecule strategy in immunotherapy, thanks to the increasingly understood role of c-Myc in the biology of T lymphocytes ", says Kevin McBride, partner and chief scientist at AmorChem.

"The participation in KNOCK OUT TM 2019 by Dr. Tarik Möröy and Dr. Nicolas Moitessier convinced us that their respective expertise in molecular biology as well as in medicinal and computational chemistry offer the ideal combination of know-how to overcome the difficulties presented by this target, "explains Inès Holzbaur, managing partner at AmorChem.

"Beyond c-Myc, the platform developed within the framework of the project offers AmorChem the unique opportunity to develop other drugs based on POZ domains by targeting other important targets", adds Elizabeth Douville, managing partner at AmorChem.

"The participation of McGill University in this kind of research with high commercial potential is a major issue for our University," said Sylvain Coulombe, Assistant Vice-Principal, Innovation and Partnerships, McGill University. "Our priority will always be to enable our world-class research to produce innovations that can save lives. This collaboration allows us to be more ready to achieve this goal. "

"The IRCM values collaboration and we are convinced of the benefits of bringing together the best experts around a project. We are therefore delighted to receive the support of AmorChem for this promising collaborative project which aims to develop new therapeutic strategies for the future, "said Max Fehlmann, President and Scientific Director of the IRCM.

"The promotion of university research is not an easy exercise. It requires the involvement of several partners who must work around a common vision of maturation and thus take concerted actions to de-risk innovations and create commercial value. The collaboration between the IRCM, McGill University, Univalor and AmorChem is a very good example of such a partnership. Funding from AmorChem will thus enable the potential of the new platform developed by the teams of Professors Möröy and Moitessier to be validated and its commercial value to be demonstrated, "says Luc Paquet, President and CEO of Univalor.

Moderna to Report Fourth Quarter and Full Year 2019 Financial Results on Wednesday, February 26th, 2020

On February 12, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, February 26, 2020 to report its fourth quarter and full year 2019 financial results, and provide a corporate update (Press release, Moderna Therapeutics, FEB 12, 2020, View Source [SID1234554235]).

To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 3639288. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at View Source The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for 30 days following the call.

AVEO Oncology Announces Publication of Phase 1b/2 Study of Tivozanib in Advanced, Inoperable Liver Cancer in the British Journal of Cancer

On February 12, 2020 AVEO Oncology (NASDAQ: AVEO) reported the publication of results from a monotherapy trial of tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), in patients with advanced, inoperable hepatocellular carcinoma (HCC) in the British Journal of Cancer (Press release, AVEO, FEB 12, 2020, View Source [SID1234554234]). The article, titled "A multicentre phase 1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma," is available online first via this link.

For the Phase 1b/2 tivozanib study, a total of 27 patients were enrolled. The study sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC. The recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once daily for 21 days followed by 7 days off treatment on a 28-day cycle. Median progression free and overall survival were 24 weeks and 9 months, respectively, for patients treated at the RP2D, with an overall response rate of 21%. A significant decrease in soluble plasma VEGFR-2 was also observed, suggesting adequate target engagement.

"HCC represents the fastest rising cause of cancer-related death in the U.S., with five-year survival at approximately 26%," said Michael Bailey, president and chief executive officer. "This study is an important steppingstone in understanding tivozanib’s safety and efficacy in HCC, and was the foundation for our ongoing Phase 1b/2 DEDUCTIVE study of tivozanib in combination with IMFINZI (durvalumab). As we work toward our expected filing of a New Drug Application with the FDA this quarter for tivozanib in kidney cancer, we look forward to expanding our tivozanib-immunotherapy clinical strategy as part of our effort to maximize its long-term potential."

Enrollment is currently underway in a Phase 1b/2 DEDUCTIVE study of tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with HCC who have not received prior systemic therapy. The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca.

"In a number of solid tumor indications, including metastatic liver cancer, VEGF-TKI/immunotherapy combinations are playing an increasingly important role in initial treatment selection," said Renuka Iyer, M.D., senior author of the publication and Professor of Oncology and Co-Director, Liver and Pancreas Tumor Center, Roswell Park Comprehensive Cancer Center. "Central to these combinations is the tolerability of the VEGF-TKI backbone. With an early efficacy signal and favorable tolerability profile demonstrated in this study, tivozanib shows great potential as a VEGF-TKI for such combinations. I look forward to seeing this potential elucidated in the ongoing DEDUCTIVE study of tivozanib and durvalumab in HCC."

About Tivozanib

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is intended to support a regulatory submission of tivozanib in the U.S. as a treatment for relapsed/refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.