On October 24, 2019 Orexo reported that Interim Report Q3 2019 (Press release, Orexo, OCT 24, 2019, View Source [SID1234542455]).

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!

Total net revenues of SEK 231.2 million (216.6), up 6.7 percent
Zubsolv US net revenues of SEK 182.7 million (165.4), up 10.4 percent in SEK and 3.0 percent in local currency
EBITDA of SEK 114.1 million (39.8), up 186.7 percent. EBITDA ex Abstral of SEK 71.7 million (-8.9).
US EBIT of SEK 93.4 million (55.6), up 68.0 percent
Cash flow from operating activities of SEK 135.7 million (24.5), building a cash balance of SEK 812.9 million (516.6)
Net earnings of SEK 111.7 million (62.2), up 79.6 percent
Signed license and supply agreement for Zubsolv in Australia and New Zealand with Mundipharma Pty Ltd.
SEK 32.5 million (10 percent) of the total corporate bond loan was prepaid
Signed partnership agreement with GAIA AG to develop a digital therapy for treatment of opioid dependence

CEO comments – Strong financials driving continued focus on new product opportunities and pipeline progression

During the quarter we saw significant changes in the US market against which Zubsolv continued to perform well and the company reported another strong financial performance. These results, along with our solid cash position, provide the necessary headroom to advance our promising pipeline of opioid focused products, whilst also embracing the trend towards the adoption of complementary digital therapeutics.

All-Time-High financial performance – EBITDA reached SEK 114 million
Following a very strong second quarter, I am pleased to report another period marked by strong financial results. Also when excluding the Abstral royalty we show strong numbers, as EBITDA ex Abstral amounted to SEK 71.7 million (-8,9). This is driven by increased sales of Zubsolv in market segments with below average rebates. The results also reflect improved efficiency measures introduced at Orexo and some adjustment of lower returns and rebates relating to prior periods. The financial result has been achieved against some short-term headwinds with three payers removing exclusivity for Zubsolv and expanding reimbursement to include other products. For Zubsolv, the immediate impact is competition in the previously exclusive contracts, WellCare, Humana and United Health Group. Longer term, Zubsolv will benefit from more payers opening up for reimbursement of Zubsolv with lower rebates. I am encouraged to see continued double digit growth for Zubsolv in the plans not impacted by changes in market access and where the rebates are lower than the exclusive contracts.

Market Dynamics – increased funding of treatment will improve the business case
A topic that has attracted media attention is the ongoing lawsuits of manufacturers of opioid pain medication. Orexo is not implicated in any of these cases, but some of the damages from these lawsuits is expected to be used to improve the treatment for opioid addiction. In many states, patient advocacy groups have lobbied for universal access for all treatment options. This has resulted in legislative changes in some states to force publicly financed payers to reimburse all products, including Zubsolv. The increased funding of treatment will also encourage the introduction of new treatment options, which bodes well for Orexo’s pipeline of opioid treatments, including our recent foray into digital therapeutics – increasingly seen as critical to successfully treating opioid addiction.

Digital Therapies – an exciting, growing market set to improve patient outcomes
The use of digital therapeutics is increasing with digital poised to play a key role in most, if not all, future interactions with health care providers. Based on our existing infrastructure and our knowledge of the addiction market, Orexo is well positioned to become a leader in bringing new digital treatment solutions to the market. Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients. Our partnership with GAIA, announced in August, is a good example of this strategy in action. GAIA has collated evidence from more than 10,000 patients that supports the use of their digital Cognitive Behavioral Therapy in depression and alcohol addiction to improve treatment outcomes. While leveraging the synergies from our existing infrastructure in the US our strategy is to continue with our considered buy and build strategy and complement our existing offering with new digital therapeutics to bring comprehensive and effective treatment solutions to improve patient outcomes.

Summary and Outlook
2019 is on track to deliver a very strong financial result enabling the company to execute on the overarching strategy to expand the commercial platform. Our next near term milestones will be the results from our ongoing OX338 study and possibly new business development agreements. Building on the financial success of Zubsolv, we have the resources to both continue broadening our pipeline and product portfolio and to build a presence in the increasingly important and complementary digital therapeutics market.

Nikolaj Sørensen
President and CEO

For further information, please contact
Nikolaj Sørensen, CEO and President, Joseph DeFeo, EVP and CFO or Lena Wange, IR & Communications Manager Tel: +46 18 780 88 00, +1 855 982 7658 Email: [email protected]

Presentation

At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Joseph DeFeo, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to [email protected] , no later than 11.00 am CET. Please view the instructions below on how to participate.
Internet: View Source
Telephone: SE: +46 8 566 427 06 UK: +44 333 300 92 67 US: +1 833 5268 383
The presentation material will be available on Orexo´s website prior to the audiocast.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on October 24, 2019.

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]).

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!

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.

On October 23, 2019 Varian (NYSE: VAR) reported it has been selected by Penn Medicine to install a Varian ProBeam 360° proton therapy system in a single-room configuration at Lancaster General Health Ann B. Barshinger Cancer Institute in south central Pennsylvania (Press release, Varian Medical Systems, OCT 23, 2019, View Source [SID1234542494]). In addition to the equipment, Varian will also provide its ARIA information management system and Eclipse treatment planning system. Construction of the new center began in September 2019, with the first patient treatments expected in 2021.

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!

In addition to the agreement on the proton therapy system, Penn Medicine and Varian also signed a research collaboration agreement. The goal of the collaboration is to enable global clinics to more easily adopt, use, and innovate modern proton therapy techniques.

With a 30 percent smaller footprint than the previous system, ProBeam 360° offers uncompromised clinical capabilities while reducing vault construction costs by approximately 25 percent. The new system has a 360-degree rotating gantry, the most powerful particle accelerator available today to treat cancer, iterative cone-beam CT imaging, and high-definition pencil-beam scanning technology. The system can also provide clinicians a viable path to potential next-generation treatments such as FLASH therapy.

The 360-degree rotating gantry of ProBeam 360° enables efficient Intensity Modulated Proton Therapy (IMPT), and faster treatment times by minimizing patient repositioning and re-imaging and allowing high-quality cone beam CT (CBCT) imaging from almost any angle. RapidScan technology, available on the ProBeam 360°, simplifies the process of motion management by delivering each field in a single breath-hold. This capability increases the number of patients who can comply with breath-hold treatments like lung SBRT.

"We look forward to continuing our strong partnership with Penn Medicine on the installation of the ProBeam 360° system and increasing access to this advanced technology," said Kolleen Kennedy, chief growth officer and president of Proton Therapy Solutions, Varian.

On October 23, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its third quarter 2019 financial results before the market opens on Wednesday, October 30, 2019 (Press release, United Therapeutics, OCT 23, 2019, View Source [SID1234542466]).

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!

United Therapeutics will host a teleconference on Wednesday, October 30, 2019, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code: 7462119.

On October 23, 2019 Boston Scientific Corporation (NYSE: BSX) reported sales of $2.707 billion during the third quarter of 2019 (Press release, Boston Scientific, OCT 23, 2019, View Source [SID1234542465]). This represents growth of 13.1 percent on a reported basis, 14.2 percent on an operational1 basis and 9.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $126 million or $0.09 per share (EPS), compared to GAAP earnings of $432 million or $0.31 per share a year ago, and achieved adjusted earnings per share of $0.39 for the period, compared to $0.35 a year ago.

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!

"Our third quarter results reflect accelerated growth fueled by several key product launches, excellent regional performance and the broad strength of our core portfolio, and we continue to invest in building a robust pipeline," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am proud of our global teams across Boston Scientific who continue to bring forward new clinical solutions that advance science and help improve patient lives."

Third quarter financial results and recent developments:

Reported third quarter sales of $2.707 billion, representing an increase of 13.1 percent on a reported basis, compared to the company’s guidance range of 8 to 10 percent; 14.2 percent on an operational basis; and 9.3 percent on an organic basis, compared to the company’s guidance range of 7.5 to 9 percent, all compared to the prior year period.3
Reported GAAP earnings of $0.09 per share compared to the company’s guidance range of $0.23 to $0.25 per share, due to acquisition-related charges in the quarter primarily associated with the acquisition of BTG plc (BTG Acquisition or BTG). Achieved adjusted earnings per share of $0.39 compared to the guidance range of $0.37 to $0.39 per share.3
Achieved third quarter revenue growth in all segments compared to the prior year period (excludes BTG Acquisition†):
MedSurg: 13.2 percent reported, 14.1 percent operational and 10.5 percent organic
Rhythm and Neuro: 5.4 percent reported, 6.5 percent operational and 3.9 percent organic
Cardiovascular: 11.3 percent reported, 12.6 percent operational and 12.6 percent organic
Reported third quarter revenue growth in all regions, compared to the prior year period (excludes BTG Acquisition†):
U.S.: 10.6 percent reported and operational
EMEA (Europe, Middle East and Africa): 6.3 percent reported and 10.8 percent operational
APAC (Asia-Pacific): 13.8 percent reported and 14.2 percent operational
Emerging Markets4: 16.1 percent reported and 19.3 percent operational
Commenced launch of the WATCHMAN Left Atrial Appendage Closure Device in Japan upon securing positive local reimbursement; surpassed 100,000 patient implants worldwide. Also presented, at the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium, budget implications data confirming that the WATCHMAN device is an affordable stroke risk reduction strategy for Medicare and Medicare beneficiaries compared to warfarin.
Announced at TCT results from the EVOLVE Short DAPT clinical trial that demonstrated that after being treated with the SYNERGY Bioabsorbable Polymer (BP) Stent, a three-month regimen of dual antiplatelet therapy (DAPT) is non-inferior to a 12-month DAPT regimen in certain patients with high bleeding risk. Also announced CE Mark for the SYNERGY MEGATRON Bioabsorbable Polymer Stent which is designed for use in large proximal vessels.
Received from the Centers for Medicare and Medicaid Services continued new technology add-on payment (NTAP) classification for the SENTINEL Cerebral Protection System and an increased add-on payment for FY2020.
Presented at TCT positive data for the LOTUS TAVR System, a mechanically-expanding valve, including a three-year analysis from the REPRISE III study demonstrating significant, sustained improvement in functional and health status following LOTUS valve implantation versus CoreValve systems (Medtronic), and significantly fewer cases of disabling stroke and moderate or greater paravalvular leak versus the CoreValve system–a self-expanding valve. Additionally, a Medicare budget impact analysis demonstrated the mechanically-expanded LOTUS valve is a less costly alternative to self-expanding valves at one year post procedure in high-risk patients with aortic stenosis.
Announced the U.S. Food and Drug Administration (FDA) approval of ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment.5
Completed clinical trial assessing the performance of the EXALT Model D Single-Use Duodenoscope during endoscopic retrograde cholangiopancreatography procedures, with positive results presented at the United European Gastroenterology Week Congress.
Announced the completion of the acquisition of BTG plc pursuant to the previously announced scheme of arrangement. In addition, divested microspheres and bland embolic bead products to Varian Medical Systems, Inc.
1. Operational revenue growth excludes the impact of foreign currency fluctuations.
2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of Claret Medical, Inc. (Claret), Augmenix, Inc. (Augmenix), Vertiflex, Inc. (Vertiflex) and BTG plc (BTG Acquisition), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.
3. As the BTG Acquisition had not yet closed, our previously disclosed third quarter guidance did not include the results of BTG.
4. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets; effective January 1, 2019, we updated our list of Emerging Market countries. We have revised prior year amounts to the current year’s presentation. The revision had an immaterial impact on prior year Emerging Markets sales.
5. 1.5 Tesla MRI conditional when all conditions of use are met.
† For the third quarter of 2019, there have been no changes to our internal reporting structure and, accordingly, we have not revised our segment reporting or geographic presentation. We will continue to integrate the BTG Acquisition into our operations in the fourth quarter and will reassess our operating and reportable segments as well as geographic presentation for any changes related to our internal reporting structure. Our results of operations include the results of BTG following the acquisition date of August 19, 2019. BTG net sales are substantially U.S. based.

Guidance for Full Year and Fourth Quarter 2019

The company estimates revenue growth for the full year 2019, versus the prior year period, to be in a range of approximately 9 to 9.5 percent on a reported basis (compared to prior guidance of 7 to 8 percent), and to be approximately 7.5 percent on an organic basis (compared to prior guidance of 7 to 8 percent). Full year organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 360 basis points from the acquisitions of Nxthera, Inc., Claret, Augmenix, Vertiflex and BTG, each with no prior period related net sales and the impact of the divestiture of our global embolic microspheres portfolio following the close of the BTG Acquisition. The company now estimates income on a GAAP basis in a range of $0.72 to $0.75 per share (compared to prior guidance of $0.94 to $0.98 per share) and estimates adjusted earnings, excluding certain charges (credits), in a range of $1.55 to $1.58 per share (compared to prior guidance of $1.54 to $1.58 per share).

The company estimates revenue growth for the fourth quarter of 2019, versus the prior year period, to be in a range of approximately 13 to 15 percent on a reported basis and a growth range of approximately 8 to 9 percent on an organic basis. Fourth quarter organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 600 to 680 basis points from the acquisitions of Vertiflex and BTG, each with no prior period related net sales and the impact of the divestiture of our global embolic microspheres portfolio following the close of the BTG Acquisition. The company estimates earnings on a GAAP basis in a range of $0.22 to $0.25 per share and adjusted earnings, excluding certain charges (credits), in a range of $0.42 to $0.45 per share.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.