Lilly Announces Cash Tender Offer for Up to $2.0 Billion Aggregate Principal Amount of Its Outstanding Debt Securities

On October 24, 2019 Eli Lilly and Company (NYSE: LLY) reported that it has commenced a cash tender offer for up to $2.0 billion aggregate principal amount (the "tender cap") of specified series of its outstanding debt (Press release, Eli Lilly, OCT 24, 2019, View Source [SID1234542490]). Pursuant to the tender offer, Lilly is offering to purchase, under certain conditions and subject to certain limitations, its 3.950% Notes due 2047, 3.700% Notes due 2045, 3.875% Notes due 2039, 7.125% Notes due 2025, 6.77% Notes due 2036, 5.950% Notes due 2037, 5.55% Notes due 2037, 5.50% Notes due 2027, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 (collectively, the "notes").

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The early tender date is 5:00 p.m., New York City time, on November 6, 2019, unless extended. The expiration date of the tender offer is 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated. The terms, conditions and limitations of the tender offer are described in the Offer to Purchase dated as of today’s date.

Holders of notes must validly tender and not validly withdraw their notes before the early tender date to be eligible to receive the total consideration (as described below). Tendered notes may only be withdrawn prior to 5:00 p.m., New York City time, on November 6, 2019. Notes tendered after the withdrawal date and before the expiration date may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

Subject to the tender cap, tendered notes will be accepted in the order of the acceptance priority levels set forth in the table above, except that the aggregate principal amount of the 3.950% Notes due 2049 accepted will not exceed the 3.95% note cap, the aggregate principal amount of the 4.150% Notes due 2049 accepted will not exceed the 4.15% note cap, and the aggregate principal amount of the 2.350% Notes due 2022 accepted will not exceed the 2.35% note cap. Lilly reserves the right, but is not obligated, to increase the tender cap or the note caps. Tenders of 3.950% Notes due 2047, 3.875% Notes 2039, 3.700% Notes due 2045, 5.950% Notes due 2037, 5.50% Notes due 2027, 5.55% Notes due 2037, 4.650% Notes due 2044, 3.100% Notes due 2027, 2.750% Notes due 2025, 3.375% Notes due 2029, 3.950% Notes due 2049, 4.150% Notes due 2059 and 2.350% Notes due 2022 will be accepted only in principal amounts equal to $2,000 and integral multiples of $1,000 in excess thereof. Tenders of 6.77% Notes due 2036 and 7.125% Notes due 2025 will be accepted only in principal amounts equal to $1,000 and integral multiples thereof.

The total consideration for each $1,000 principal amount of notes tendered and accepted for payment by Lilly pursuant to the tender offer will be determined in the manner described in the Offer to Purchase by reference to a fixed spread specified in the table above for each series of the notes and over the yield based on the bid-side price of the U.S. Treasury Security specified in the table above, as calculated by Citigroup Global Markets Inc., Morgan Stanley & Co. LLC, BNP Paribas Securities Corp. and J.P. Morgan Securities LLC for the tender offer at 10:00 a.m., New York City time, on November 7, 2019. Holders of notes who validly tender their notes after the early tender date will, if such notes are accepted by Lilly, receive the tender consideration, which is equal to the total consideration minus $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued and unpaid interest up to, but excluding, the applicable settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

Lilly reserves the right, but is under no obligation, at any point following the early tender date and before the expiration date of the tender offer, to accept for purchase any notes validly tendered (and not validly withdrawn) at or prior to the early tender date. The initial settlement date will be determined at Lilly’s option and is currently expected to occur on November 8, 2019. Regardless of whether Lilly chooses to exercise its option to have an initial settlement date, Lilly will purchase any remaining notes that have been validly tendered (and not validly withdrawn) by the expiration date of the tender offer and accepted for purchase (subject to the tender cap, the note caps, and the application of the acceptance priority levels), promptly following the expiration date of the tender offer.

All notes validly tendered and not validly withdrawn before the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any tendered notes having a lower acceptance priority level, and all notes validly tendered after the early tender date having a higher acceptance priority level will be accepted (subject to the tender cap and the note caps) before any notes tendered after the early tender date having a lower acceptance priority level. However, notes validly tendered and not validly withdrawn on or before the early tender date will be accepted for purchase (subject to the tender cap and the note caps) in priority to other notes tendered after the early tender date, even if such notes tendered after the early tender date have a higher acceptance priority level than notes tendered prior to the early tender date.

Notes accepted for purchase in accordance with the terms and conditions of the tender offer may be subject to proration (rounded down to avoid the purchase of notes in a principal amount other than in integral multiples of $1,000), so that Lilly will only accept for purchase notes in an aggregate principal amount up to the tender cap, including the maximum amount of 3.950% Notes due 2049 that may be purchased pursuant to the 3.95% note cap, 4.150% Notes due 2059 that may be purchased pursuant to the 4.15% note cap, and 2.350% Notes due 2022 that may be purchased pursuant to the 2.35% note cap. If purchasing all of the tendered notes of a series of notes of an applicable acceptance priority level on any settlement date would cause the tender cap and the note caps to be exceeded, the amount of that series of notes purchased on that settlement date will be prorated based on the aggregate principal amount of that series of notes tendered in respect of that settlement date such that the tender cap and the note caps will not be exceeded. Furthermore, if the tender offer is fully subscribed as of the early tender date, holders who validly tender notes after the early tender date will not have their notes accepted for payment.

The offer for each series of notes is conditioned upon the satisfaction of certain conditions, including the completion of an offering of debt securities by Lilly on terms and conditions satisfactory to Lilly that results in the receipt of net proceeds that, when taken together with cash on hand, is sufficient to pay the consideration for all tendered notes validly tendered (and not validly withdrawn) and accepted for purchase by Lilly, plus related accrued and unpaid interest and fees and expenses. The offer is not conditioned on a minimum principal amount of notes being tendered nor the consummation of any other offer. The offer with respect to one or more series of the notes may be amended, extended, terminated or withdrawn separately.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

This press release is for informational purposes only and is not a tender offer to purchase or a solicitation of acceptance of a tender offer, which may be made only pursuant to the terms of the Offer to Purchase. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. In addition, this press release is not an offer to sell or the solicitation of an offer to buy any securities. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any such securities will be offered only by means of a prospectus, including a prospectus supplement relating to such securities, meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

NOXXON Publishes Interim 2019 Results

On October 24, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), released reported its interim 2019 results for the six months ended June 30, 2019 (Press release, Noxxon, OCT 24, 2019, View Source [SID1234542506]).

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Aram Mangasarian, Chief Executive Officer of NOXXON, commented: "NOXXON has made significant progress in the clinical development of our lead drug candidate, NOX-A12, obtaining near-final data from the trial testing NOX-A12 with immunotherapy in metastatic micro-satellite stable pancreatic and colorectal cancer patients and initiating the NOX-A12 and radiotherapy combination trial in first-line therapy for brain cancer patients. We continue to develop relationships with potential partners with the goal to set up an agreement to share the financial resources needed to advance our drug candidate for the treatment of cancer."

Business Overview

NOXXON is focused on advancing clinical trials to test its lead drug candidate, NOX-A12, an anti-CXCL12 agent, in two distinct therapeutic combinations: NOX-A12 + radiotherapy and NOX-A12 + immunotherapy (PD1 checkpoint inhibitors). Each combination approach has a different underlying rationale and mechanism of action.

The combination approach of NOX-A12 + radiotherapy is currently being tested as a first line therapy in a Phase 1/2 trial in newly diagnosed patients with aggressive brain cancer (glioblastoma) who would not benefit from standard of care chemotherapy and whose tumor cannot be fully resected by surgery. The anticipated mode of action of NOX-A12 is the inhibition of a process called "vasculogenesis" which allows the tumor’s blood vessels that were destroyed by the radiotherapy to be replaced, which ultimately results in disease recurrence.

The combination of NOX-A12 + immunotherapy has been tested in a Phase 1/2 trial in patients with metastatic pancreatic and colorectal cancer who had failed several lines of standard therapy. Both the NOX-A12 mechanistic data as well as the overall survival figures observed following treatment with the combination of NOX-A12 and anti-PD1 have been highly encouraging for the patient population enrolled in this study. Three patients (15% of the total) with advanced metastatic disease, including metastases in the liver, whose cancer was progressing rapidly at the time of trial entry have survived for more than one year.

Partnering discussions resulted in one of the top-10 global pharmaceutical companies initiating an experimental preclinical evaluation of NOX-A12 in a novel indication. The indication is a serious disease with significant unmet medical need and a market valued at more than one billion euros.

Business Highlights During First Half-Year of 2019

February 2019: Aachen University Hospital researchers published work showing that blocking the recruitment of macrophages in the liver with an anti-CCL2 molecule, such as NOX-E36, is a promising mechanism for the treatment of liver cancer. This is the second solid tumor for which monotherapy activity of NOX-E36 has been demonstrated after pancreas cancer.
February 2019: NOXXON filed the clinical trial application with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
April 2019: An update of clinical results from the Phase 1/2 study of NOX-A12 in combination with Keytruda (pembrolizumab) in patients with microsatellite-stable, metastatic pancreatic and colorectal cancer was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data confirmed that NOX-A12 is safe and well-tolerated in advanced cancer patients both as a monotherapy and in combination with Merck and Co./MSD’s anti-PD1 antibody pembrolizumab. The combination of NOX-A12 and pembrolizumab induced stable disease in 25% of patients and prolonged time on treatment vs. prior therapy for 35% of patients. Overall survival figures were very encouraging for this patient population.
June 2019: A top-10 pharmaceutical company signed an agreement with NOXXON for the purpose of evaluating NOX-A12 in a novel indication. The pharmaceutical company will fund and conduct preclinical studies to assess NOX-A12 in an indication which is a serious disease with significant unmet medical need. The market for this indication has been valued at more than one billion euros. The studies are anticipated to be completed in Q2 2020, after which the parties may enter negotiations for rights to NOX-A12.
Business Highlights After June 30, 2019

July and August 2019: NOXXON raised €1.5 million though two capital increases.
September 2019: NOXXON initiated recruitment of newly diagnosed brain cancer patients in a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy.
September 2019: NOXXON presented more mature top-line data from the NOX-A12 clinical trial in metastatic microsatellite stable pancreatic and colorectal cancer patients at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting. Three patients (15% of the total) have now survived over one year despite having failed at least three prior lines of therapy. It should also be noted that these patients experienced rapid cancer progression as the best response to their last therapy just prior to entering the NOX-A12 trial. This data provides further support to the concept that the combination of NOX-A12 + anti-PD1 immunotherapy is able to modify the biology of the tumor to the benefit of the patient.
October 2019: NOXXON announced initiation of treatment of the first brain cancer patient in the Phase 1/2 clinical trial combining the CXCL12 inhibitor NOX-A12 with radiotherapy.
First-half 2019 Financial Results (IFRS)

NOXXON Pharma did not generate any revenues in the first half of 2019 (H1 2019). The Group does not expect to generate any revenues from its product candidates in development until the company either signs a licensing agreement or obtains regulatory approval and commercializes its products or enters into collaborative agreements with third parties.

The increase in other operating income to €274 thousand in H1 2019 (vs. €77 thousand in H1 2018) was mainly due to the sale of raw materials and a partial waiver of management and supervisory board members concerning their receivables from remuneration due from the Group in 2019, which generated higher other operating income than the sale of assets held for sale in H1 2018.

NOXXON dedicated its resources to research and development (R&D) and general and administrative (G&A) expenses. R&D expenses slightly decreased to €1,062 thousand in H1 2019 (vs. €1,189 thousand in H1 2018). The decrease was mainly driven by lower personnel expenses, patent costs and consulting services.

The decrease in G&A expenses to €1,238 thousand in H1 2019 (vs. €1,359 thousand in H1 2018) was mainly driven by lower personnel expenses, lower public and investor relation expenses, partly offset by higher legal, consulting and audit fees.

Foreign exchange losses in the amount of €2 thousand remained at par in H1 2019 and in H1 2018 as a result of unchanged volume of purchases denominated in currencies other than euro in H1 2019.

Finance income increased to €75 thousand in H1 2019 (vs. €59 thousand in H1 2018). Finance income in H1 2018 and H1 2019 was due to the fair value adjustments of warrants issued and outstanding and was entirely non-cash related.

No finance cost was reported in H1 2019 (vs. €1,637 thousand in H1 2018). Finance cost in H1 2018 was related to the Yorkville equity line financing and included the consideration incurred in connection with the amendment of the Issuance Agreement with Yorkville, the conversions of outstanding notes in equity as well as the issuance of notes and the recognition of warrants. Finance cost in H1 2018 was entirely non-cash related.

As a result of the above factors, NOXXON’s net loss decreased to €1,954 thousand in H1 2019 (vs. €4,051 thousand in H1 2018). The net cash used in operating activities amounted to €2,687 thousand in H1 2019 and €1,757 thousand in H1 2018, respectively.

Having obtained and published more mature data from the NOX-A12 clinical trial in metastatic microsatellite stable pancreatic and colorectal cancer patients in September 2019, NOXXON believes that further clinical trials in these indications are warranted. The company’s goal is to find industrial partners to provide an anti-PD1 therapy and financial support to conduct a trial. Since finalizing such a partnership is taking more time than anticipated and some of the discussions have not advanced as hoped – in particular with regards to financial support of further trials – the company has broadened the range of potential industrial partners in discussions.

NOXXON initiated the Phase 1/2 combination trial of NOX-A12 with radiotherapy in front-line, inoperable brain cancer (glioblastoma) patients who are shown by biomarker analysis to be resistant to the current standard of care chemotherapy. If the data from this study show positive results, the company will seek advice from competent authorities under the orphan drug designation in the United States and Europe to identify the most efficient manner to complete development in this indication.

The company’s partnering objective for this combination is to identify industrial partners that will finance additional clinical trials in brain cancer and other indications where radiotherapy is core to the standard of care. NOXXON anticipates that at least partial top-line clinical data from this trial will be required to sign a partnership in this area.

NOXXON is encouraged by the support of the neuro-oncology community and the strong pull exerted to test NOX-A12 + radiotherapy in the brain cancer setting. In parallel, US-based university consortia are seeking their own funding to test NOX-A12 combined with radiotherapy in adult and pediatric brain cancers. For the clinical trials to proceed, should the consortia be successful in raising funds, NOXXON would need to consider production and supply of NOX-A12.

The ongoing evaluation by a leading international pharmaceutical company of NOX-A12 in a novel indication has created a potentially significant opportunity for NOXXON. It is anticipated that the preclinical work and analysis of the results will be completed in Q2 2020, after which the parties may enter negotiations for rights to NOX-A12.

NOXXON continues to evaluate other indications and therapeutic combinations in which to test NOX‑A12 and NOX-E36 as well as the relative priority of such indications for the overall corporate strategy.

Based on its present requirements resulting from the Group’s updated business plan focusing on clinical development of its lead product candidate NOX-A12 for the treatment of advanced solid tumors, the Group will require additional cash resources of approximately € 2.5 million, to provide the Group with sufficient working capital for the twelve months following the date of these interim financial statements. The Group will be required to raise these additional funds, alternative means of financial support or conduct a partnering deal for one of its product candidates during February 2020 with a cash inflow be available during the month of February 2020 in order to continue its operations.

Management is pursuing various financing alternatives to meet the Group’s future cash requirements, including seeking additional investors, pursuing industrial partnerships, or obtaining further funding from existing investors through additional funding rounds, pursuing a merger or an acquisition. The management of NOXXON is pursuing all of these avenues in parallel with the assistance of experienced external support. Based on the options available and a past history of timely funding the operations of the Group, management is confident to be able to raise additional capital, preferably in the form of equity or an industrial partnership.

Spectrum Pharmaceuticals Announces Submission to the U.S. Food and Drug Administration of Updated Biologics License Application for ROLONTIS®

On October 24, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, reported that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim) (Press release, Spectrum Pharmaceuticals, OCT 24, 2019, View Source [SID1234542527]).

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The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in Duration of Severe Neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both studies.

"We have submitted a robust package to the FDA that incorporates strong clinical data and addresses previously communicated FDA requests relating to manufacturing processes," said Joe Turgeon, President and CEO of Spectrum. "ROLONTIS could be the first novel G-CSF available to healthcare providers in over 15 years and, if approved, we are looking forward to competing in this multibillion-dollar market."

In March 2019, Spectrum voluntarily withdrew the ROLONTIS BLA that it filed with the FDA in 2018. The updated BLA filed today includes additional information in the Chemistry, Manufacturing and Controls (CMC) section.

About ADVANCE

The ADVANCE trial was a Phase 3, multicenter, randomized, active-controlled, open label trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized in a 1:1 ratio to receive ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary trial endpoint was the DSN (absolute neutrophil counts [ANC] <0.5×109/L) in Cycle 1, based on central laboratory assessment of ANC over the 21-day cycle. Secondary endpoints included the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated with four cycles of adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single dose of either eflapegrastim 13.2 mg/0.6 mL (3.6 mg G-CSF) or pegfilgrastim (6 mg) subcutaneously. ADVANCE was conducted under a special protocol assessment (SPA) with the FDA.

About RECOVER

The RECOVER trial was a Phase 3, multicenter, randomized, active-controlled, open label trial that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive ROLONTIS (n=118) or pegfilgrastim (n=119). The primary trial endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×10^9/L), based on central laboratory assessment of ANC over a 21-day cycle. Secondary endpoints included the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated on Day 1 of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single dose of either eflapegrastim 13.2 mg/0.6 mL (3.6 mg G-CSF) or pegfilgrastim (6 mg) subcutaneously.

Athenex, Inc. to Report Third Quarter 2019 Earnings Results on November 7, 2019

On October 24, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release third quarter and nine-months ended September 30, 2019 financial results on Thursday, November 7, 2019, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, OCT 24, 2019, View Source [SID1234573884]).

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13694941. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

Ipsen Delivers Strong Double-digit Sales Growth for the Third Quarter of 2019 and Confirms Full Year 2019 Guidance

On October 24, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2019 (Press release, Ipsen, OCT 24, 2019, View Source [SID1234542454]).

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Financial highlights

Q3 2019 Group sales growth of +16.0% as reported and +14.5%1 at constant exchange rates and consolidation scope, driven by Specialty Care sales growth of 16.5%1, reflecting strong double-digit momentum of Somatuline (lanreotide) and the continued growth from Cabometyx (cabozantinib) and Decapeptyl (triptorelin)
YTD Group sales growth of +15.7% as reported and +14.3%1 at constant exchange rates and consolidation scope fueled by strong Specialty Care sales growth of 16.8%1
Full Year 2019 guidance confirmed with Group sales growth greater than +14.0% at constant currency and consolidation scope1 and Core Operating margin at around 30.0% of net sales
Recent pipeline highlights

Positive interim Phase 1/2 clinical data evaluating Onivyde (liposomal irinotecan) as first-line treatment for metastatic pancreatic cancer presented at ESMO (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer
Positive interim data from seamless Phase 2/3 clinical trial evaluating Onivyde as a second-line treatment for small cell lung cancer (SCLC) presented at the IASLC 2019 World Conference on Lung Cancer
FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP)
In-licensing of BLU-782 from Blueprint Medicines, a highly selective ALK2 inhibitor in Phase 1 development for the treatment of fibrodysplasia ossificans progressiva (FOP)
Palovarotene regulatory submission to the FDA for the episodic treatment of FOP now expected in Q1 2020 as a result of the processing of additional supportive data.
Key figures

Unaudited IFRS consolidated sales

Third Quarter

Nine Months

(in million euros)

2019

2018

%

Variation

%

Variation

at constant

currency and

consolidation

scope1

2019

2018

%

Variation

%

Variation at

constant currency

and consolidation

scope 1

Specialty Care

574.2

484.1

18.6%

16.5%

1,674.1

1,404.2

19.2%

16.8%

Consumer Healthcare2

70.6

71.9

-1.8%

0.1%

200.2

216.2

-7.4%

-2.4%

Group sales

644.7

555.9

16.0%

14.5%

1,874.3

1,620.4

15.7%

14.3%

1 Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. 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.

David Meek, Chief Executive Officer of Ipsen stated: "In the third quarter, we continued to execute on our objectives with a strong performance of our Specialty Care business, including double-digit growth of Somatuline in both the U.S. and Europe. With our excellent performance year-to-date, we are increasingly confident in our ability to achieve our 2019 financial guidance.

"We remain focused on the successful execution of the palovarotene program to bring the first therapeutic treatment to FOP patients as expeditiously as possible. We also continue to deliver on our external innovation strategy. The recent in-licensing of BLU-782 reinforces our leadership in FOP with a different and potentially complementary mechanism of action to palovarotene, expands our portfolio approach in this complex ultra-rare bone disorder and leverages our clinical and commercial capabilities. Advancing our pipeline remains a key focus going forward to deliver on our growth strategy and to bring additional value to patients and shareholders."

Third quarter 2019 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts (currency effects established by recalculating net sales for the relevant period at the exchange rates from the previous period)

Q3 2019 Group sales grew 14.5%1 to €644.7 million.

Sales of Specialty Care products reached €574.2 million, up 16.5% year-on-year.

Somatuline sales reached €264.0 million, up 18.8%, year-on-year, driven by 20.0% growth in North America, double-digit growth in key European countries and good performance in Japan.

Decapeptyl sales reached €98.9 million, up 10.5% year-on-year, driven by volume and market share gains in Europe and double-digit growth in China.

Cabometyx sales reached €64.5 million, growing 66.3% year-on-year, driven by the good performance in all launched European countries and additional launches in Asia and Oceania.

Onivyde sales reached €26.1 million, down 7.3% year-on-year, impacted by limited shipments to Ipsen’s ex-U.S. partner in the third quarter.

Dysport sales reached €97.4 million, up 8.8% year-on-year, driven by the solid performance in the U.S. in the therapeutics and aesthetics markets, as well as growth from Galderma in Europe.

Consumer Healthcare product sales totaled €70.6 million, stable at +0.1%1, driven by Smecta growth of 2.5% year-on-year, from the good performance in France and in China despite the new hospital competitive pricing environment, and Forlax growth of 9.7% year-on-year. Tanakan sales reached €8.8 million, down 10.0% year-on-year, due to competitive pressure in emerging countries and a market slowdown in France.

Confirmation of Full Year 2019 guidance

Group sales growth greater than +14.0% at constant currency and consolidation scope1
Impact of currencies estimated at +2.0% based on the current level of exchange rates
Impact of consolidation scope reflecting the consolidation under the equity method for joint arrangements related to the Schwabe partnership estimated at -1.0%
Core Operating margin at around 30.0% of net sales
Conference call

Ipsen will hold a conference call Thursday, 24 October 2019 at 2:30 p.m. (Paris time, GMT+2). 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: 08-445-718-892
U.S.: 1-6315-107-495
Conference ID: 5649858

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