On October 31, 2019 Learmont Pharmaceuticals presented the corporate presentation (Press release, NanOlogy, OCT 31, 2019, View Source [SID1234550177]).

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On October 31, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK) (Press release, Takeda, OCT 31, 2019, View Source [SID1234550063]):

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Underlying Revenue declined -0.2% vs FY2018 H1 pro-forma revenue2

Takeda’s 14 global brands with reported revenue of 547.0 billion yen in aggregate posted a strong year-over-year underlying growth of +21%, driven by ENTYVIO growing +33.9%, ALBUMIN/FLEXBUMIN growing +16.9%, and NINLARO growing +32.7%, offset by the negative impact of intensified competition and generic erosion.
Underlying growth in key business areas for FY2019 H1: GI (+9%), Oncology (+11%), Neuroscience (+6%), and Plasma Derived Therapy (PDT) Immunology (+4%), offset by Rare Disease (-11%) due to decline as expected in Rare Hematology.
Within Rare Disease, Rare Hematology continues to be impacted by competition and price pressure, and growth in Hereditary Angioedema (HAE) was negatively affected by stocking in the prior year as well as generic entry for FIRAZYR.
Immunoglobulin returned to growth as expected in the 3 months of FY2019 Q2 at an underlying growth rate of +7.6% and +3% for H1, over the same period of last year.
Underlying Core Operating Profit Margin of 32.2% for FY2019 H1 with cost synergies and OPEX efficiencies driving margins

Reported Operating Profit declined -70.7% to 50.3 billion yen, largely impacted by non-cash purchase accounting expenses including unwinding of inventory step-up, increased amortization of intangibles, as well as one-time integration costs.
Core Operating Profit increased +155.5% to 541.6 billion yen primarily due to the acquisition of Shire, solid performance of 14 global growth brands and improved operating efficiency partially offset by the negative impact of intensified competition and generic erosion.
Underlying Core Operating Profit Margin for FY2019 H1 was 32.2% reflecting continued OPEX discipline and cost synergies.
Underlying Core EPS for H1 was 249 yen.
Investing in future growth by adding 23 plasma collection centers since the closing of the Shire acquisition, acquiring license for first-in-class celiac disease therapy (TAK-101) from COUR Pharmaceuticals, and continued investment in our R&D engine.
1

Please refer to note iii in Reported Results for H1 (April – June) FY2019 table for Core Operating Profit definition.

2

Growth versus FY2018 H1 pro-forma revenue (6-month April-September 2018 combined revenue of Legacy Takeda and Legacy Shire, excludes its oncology business and US GAAP results were conformed to IFRS, without material differences). Please see the appendix for more details.

Achieved Several Important Pipeline Milestones

Data presented at World Sleep Congress demonstrated early evidence of efficacy for TAK-925 in Narcolepsy Type 1.
ENTYVIO head-to-head study and TAK-620 (Maribavir) Ph-2 data published in The New England Journal of Medicine.
TRINTELLIX approved in Japan for the treatment of depression and depressed state.
Submitted a Marketing Authorization Application (MAA) in Japan for a subcutaneous formulation of ENTYVIO for patients with moderately to severely active ulcerative colitis.
8 potential best-in-class or first-in-class New Molecular Entities (NMEs) in pivotal studies.
Divesting non-core assets to accelerate deleveraging and focus the business

Paid down 584.5 billion yen of debt and de-levered from 4.7x at end of FY2018 to 3.9x Net debt / adjusted EBITDA as of September 2019. This does not include the sale of OTC and prescription pharmaceutical assets in certain Near East, Middle East and Africa countries to Acino for more than $200 million.
Negotiations ongoing for further potential divestments.
Christophe Weber, Chief Executive Officer, commented:

"We are pleased with our recent financial results, which reflect strong underlying performance across our 14 global brands and OPEX improvements that has allowed us to raise our guidance. I am particularly encouraged by the rapid de-leveraging year-to-date.
We are also satisfied with the progress of our integration efforts. Takeda employees are excited and engaged around our next phase of growth and our undeniable progress towards becoming one integrated company.
Our excitement around the future of Takeda is also derived from the strength and breadth of our pipeline. We look forward to providing some additional insight and commentary around our portfolio, pipeline, and growth strategy at our upcoming R&D Day in November."

Reported Results for FY2019 H1 (April – June)

(billion yen)

REPORTED

CORE

UNDERLYING i.

FY2019 H1

VS. PRIOR YEAR

FY2019 H1

VS. PRIOR YEAR

Revenue

1,660.2

+88.5%

1,660.2

+88.5%

-0.2% y-o-y ii.

(pro-forma)

Operating Profit

50.3

-70.7%

541.6 iii.

+155.5%

Margin

3.0%

-16.5pp

32.6%

+8.6pp

32.2%

Net Profit iv.

33.2

-73.8%

380.4

+130.3%

EPS (JPY)

21 yen

-140 yen

244 yen

+33 yen

249 yen

i.

Underlying Growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

ii.

Growth versus FY2018 H1 pro-forma revenue. Pro-forma revenue is the 6-month April-September 2018 combined revenue of Legacy Takeda and Legacy Shire, US GAAP results conformed to IFRS, without material differences. The adjustments also include removal of impacts related to Shire’s oncology business which was divested in August 2018.

iii.

Core Operating Profit represents net profit adjusted to exclude income tax expenses, our share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs.

iv.

Attributable to the owners of the company.

FY2019 Management Guidance: Upgrading guidance to reflect positive business momentum

Previous Guidance
(July 31, 2019)

Revised Guidance
(October 31, 2019)

Underlying Revenue Growth i.

Flat to slightly increasing

Flat to slightly increasing

Underlying Core Operating Profit Margin

Mid-to-high-twenties %

High-twenties %

Underlying Core EPS

360 – 380 yen

370 – 390 yen

Annual Dividend per Share

180 yen

180 yen

i.
Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate of 111 JPY/USD) compared to baseline of JPY 3,300 billion (Rounded pro-forma April 2018-March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018-March 2019 average exchange rate of 111 JPY/USD; also adjusted to remove the revenue from divested assets such as Techpool, Multilab, and TACHOSIL from Legacy Takeda, and the oncology portfolio and XIIDRA from Legacy Shire) and conformed from US GAAP to IFRS, without material differences.

FY2019 Reported Forecast: Revenue decreasing due to FX impact, but profit increasing

For more details on Takeda’s FY2019 Q2 results and other financial information, please visit View Source

Takeda to Host R&D Day on November 14 in New York, Plasma-Derived Therapies Day on November 15 in Covington, GA, and R&D and Plasma-Derived Therapies Day on November 21 in Tokyo;

At each event, Takeda executives are expected to discuss, among other things, the Company’s near-term and sustained growth strategies and next-generation platforms. Each event will be accessible via a live webcast on the Investors section of the Company’s website: View Sourcequarterly-announcements/quarterly-announcements-2019/.
A replay of each webcast will be archived on the website along with the presentation slides associated with each event.

On October 31, 2019 Celgene Corporation (NASDAQ: CELG) reported third quarter 2019 total revenue of $4,520 million, a 16 percent increase compared to $3,892 million in the third quarter of 2018 (Press release, Celgene, OCT 31, 2019, View Source [SID1234550102]).

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Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported net income of $1,691 million and diluted earnings per share (EPS) of $2.32 for the third quarter of 2019. For the third quarter of 2018, GAAP net income was $1,082 million and diluted EPS was $1.50.

Adjusted net income for the third quarter of 2019 increased 33 percent to $2,184 million compared to $1,645 million in the third quarter of 2018. For the same period, adjusted diluted EPS increased 31 percent to $2.99 from $2.29.

"Across functions and around the world, our teams delivered outstanding third quarter results," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "We are continuing to advance multiple high-potential medicines toward regulatory approvals and look forward to closing the Bristol-Myers Squibb transaction by the end of the year."

Third Quarter 2019 Financial Highlights

Unless otherwise stated, all comparisons are for the third quarter of 2019 compared to the third quarter of 2018. The adjusted operating expense categories presented below exclude share-based employee compensation expense and collaboration-related upfront expense. Please see the attached Use of Non-GAAP Financial Measures and Reconciliation of GAAP to Adjusted Net Income for further information relevant to the interpretation of adjusted financial measures and reconciliations of these adjusted financial measures to the most comparable GAAP measures, respectively.

Net Product Sales Performance

·REVLIMID sales for the third quarter were $2,770 million, an increase of 13 percent year-over-year. U.S. sales were $1,902 million and international sales were $868 million, an increase of 14 percent and 11 percent year-over-year, respectively. REVLIMID sales growth was driven primarily by the adoption of triplet therapy for myeloma resulting in increases in treatment duration and market share.

·POMALYST/IMNOVID sales for the third quarter were $664 million, an increase of 29 percent year-over-year. U.S. sales were $469 million and international sales were $195 million, an increase of 31 percent and 25 percent year-over-year, respectively. POMALYST/IMNOVID sales growth was driven primarily by the adoption of triplet therapy for myeloma resulting in increases in treatment duration and market share.

·OTEZLA sales for the third quarter were $547 million, an increase of 27 percent year-over-year. U.S. sales were $445 million and international sales were $102 million, an increase of 28 percent and 21 percent year-over-year, respectively. OTEZLA sales growth in the U.S. was driven by increase in demand, while international sales were driven by continued uptake in key markets.

·ABRAXANE sales for the third quarter were $318 million, an increase of 10 percent year-over-year. U.S. sales were $206 million and international sales were $112 million, an increase of 18 percent and a decrease of 2 percent year-over-year, respectively. ABRAXANE sales growth was driven primarily by increased demand due to immuno-oncology (IO) combinations in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

·In the third quarter, all other product sales, which include INREBIC, IDHIFA, THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product primarily sold in the U.S., were $219 million compared to $208 million in the third quarter of 2018.

Research and Development (R&D)

On a GAAP basis, R&D expenses were $1,167 million for the third quarter of 2019 compared to $1,081 million for the same period in 2018. Adjusted R&D expenses were $928 million for the third quarter of 2019 compared to $948 million for the third quarter of 2018. The decrease in adjusted R&D expense was driven by reductions in expenses related to certain collaboration arrangements and regulatory submission-related work on multiple programs. Additional R&D expenses (only included on a GAAP basis) increased in 2019, as outlined in the attached Reconciliation of GAAP to Adjusted Net Income.

Selling, General and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $781 million for the third quarter of 2019 compared to $746 million for the same period in 2018. Adjusted SG&A expenses were $700 million for the third quarter of 2019 compared to $642 million for the third quarter of 2018. The increase was driven primarily by increased pre-launch marketing-related expenses. Additional SG&A expense (only included on a GAAP basis) decreased in 2019, as outlined in the attached Reconciliation of GAAP to Adjusted Net Income.

Cash, Cash Equivalents, Marketable Debt Securities and Publicly-Traded Equity Securities

Operating cash flow was $2.2 billion in the third quarter of 2019, compared to $1.9 billion for the third quarter of 2018. Celgene ended the quarter with approximately $10.9 billion in cash, cash equivalents, marketable debt securities and publicly-traded equity securities.

Portfolio Updates

·INREBIC (fedratinib):

·In August, Celgene announced that the U.S. Food and Drug Administration (FDA) approved INREBIC (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis

·The Marketing Authorization Application (MAA) submission in the European Union is planned by year-end 2019

·Luspatercept1:

·The U.S. FDA accepted the Biologics License Application (BLA) for luspatercept for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions and set a Prescription Drug User Fee Act (PDUFA) date of December 4, 2019

·The U.S. FDA accepted the BLA for luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require regular RBC transfusions and set a PDUFA date of April 4, 2020

·The MAA for luspatercept for the treatment of adult patients with beta-thalassemia and MDS has been accepted for review by the European Medicines Agency (EMA)

·Liso-cel (JCAR017):

·The BLA submission for liso-cel in patients with relapsed or refractory large B-cell lymphoma after at least 2 prior therapies is on-track for the fourth quarter of 2019

·Ide-cel (bb2121)2:

·An update from the pivotal KarMMa trial in patients with relapsed and/or refractory multiple myeloma (RRMM) is expected by year-end 2019. The BLA submission for ide-cel in 4L+ multiple myeloma is expected in the first half of 2020

·The phase II KarMMa-2 and phase III KarMMa-3 trials in patients with 2L and 3L+ multiple myeloma, respectively, are continuing to enroll

·Initiation of a newly diagnosed multiple myeloma (NDMM) trial is planned for the fourth quarter of 2019

·CC-486:

·In September, Celgene announced that the phase III QUAZAR AML-001 trial evaluating CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy met the primary endpoint of prolonged overall survival (OS). Celgene plans regulatory submissions beginning in the first half of 2020. Data from QUAZAR AML-001 will be presented at a future medical meeting

·Ozanimod:

·The U.S. FDA accepted the New Drug Application (NDA) for ozanimod for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and set a PDUFA date of March 25, 2020

·The EMA accepted the MAA for ozanimod for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). A regulatory decision is expected in the first half of 2020

·Data from the phase III TRUE NORTH trial in patients with ulcerative colitis (UC) is expected in mid-2020

·At the 61st ASH (Free ASH Whitepaper) annual meeting in December, select anticipated data presentations include:

·Data from the pivotal TRANSCEND NHL-001 trial evaluating liso-cel in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), which includes diffuse large B-cell lymphoma (DLBCL);

·Updated data, including minimal residual disease (MRD), from the ongoing phase I/II TRANSCEND CLL-004 trial evaluating liso-cel in a heavily pretreated patient population with high-risk chronic lymphocytic leukemia (CLL);

·Initial results from the phase II PILOT trial evaluating liso-cel as second-line treatment in patients with transplant noneligible (TNE) relapsed and/or refractory NHL;

·Data from the outpatient treatment of liso-cel in multiple ongoing clinical trials in patients with relapsed/refractory B-cell NHL;

·Initial data from the phase II trial evaluating luspatercept in patients with myelofibrosis;

·Updated data from the phase I trial evaluating bb21217 in patients with RRMM;

·First clinical data from a phase I trial evaluating CC-93269, a T cell bispecific antibody targeting B-cell maturation antigen (BCMA) in patients with RRMM; and,

·First clinical data from a phase I trial evaluating CELMoD agent CC-90009 in patients with relapsed or refractory AML

1 In collaboration with Acceleron Pharma

2 In collaboration with bluebird bio

Transaction Update

·In June, Bristol-Myers Squibb announced the planned divestiture of OTEZLA (apremilast) in light of concerns raised by the U.S. Federal Trade Commission ("FTC"). In August, Celgene entered into an agreement with Amgen under which Amgen would acquire the OTEZLA (apremilast) product line and related intellectual property, including any patents that primarily cover apremilast, and other specified assets and liabilities related to the OTEZLA (apremilast) product line for $13.4 billion in cash (the "OTEZLA Divestiture"), which represents an important step towards completion of the pending merger between Bristol-Myers Squibb and Celgene. The closing of the OTEZLA Divestiture is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC) in connection with their pending merger, the closing of the pending merger between Bristol-Myers Squibb and Celgene, and the satisfaction of other customary closing conditions. The pending merger between Bristol-Myers Squibb and Celgene is expected to close by the end of 2019, subject to the FTC’s acceptance of a consent order and the satisfaction of customary closing conditions.

Third Quarter 2019 Earnings Information

Due to the pending transaction with Bristol-Myers Squibb, Celgene is not hosting a conference call in conjunction with its third-quarter 2019 earnings release and does not expect to do so for future quarters. Please direct any questions regarding this press release to Celgene Investor Relations or Celgene Communications.

On October 31, 2019 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on allogeneic gene-edited CAR T-cells (UCART), reported that it will report third quarter 2019 financial results on Wednesday, November 6, 2019, after the close of the US market (Press release, Cellectis, OCT 31, 2019, View Source [SID1234550123]). The announcement will be followed by a conference call at 8:00 AM EST / 2:00 PM CET on Thursday, November 7, 2019, prior to the open of the US market. The company is initiating investor calls accompanying its quarterly results.

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The live dial-in information for the conference call is:

US & Canada only: 877-407-3104

International: 201-493-6792

In addition, a replay of the call will be available until November 21, 2019 by calling 877-660-6853 (Toll Free US & Canada); 201-612-7415 (Toll Free International), Conference ID: 13688263

On October 31, 2019 Novocure (NASDAQ: NVCR) reported financial results for the three and nine months ended September 30, 2019, highlighting strengthening financial performance, multiple levers to drive near-term growth and building momentum for the Tumor Treating Fields platform (Press release, NovoCure, OCT 31, 2019, View Source [SID1234550139]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields.

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(1) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune or NovoTTF-100L that is received from a physician certified to treat patients for a patient not previously on Optune or NovoTTF-100L. Orders to renew or extend treatment are not included in this total.

"The third quarter 2019 was another strong quarter for Novocure," said Asaf Danziger, Novocure’s CEO. "Marked by the third consecutive quarter of greater than 40 percent year-over-year revenue growth, commercial execution drove a record $92 million in net revenues and our first quarter ever of positive net income. With multiple levers to deliver continued near-term revenue growth, cash flow from the GBM business provides the financial flexibility and stability needed to ensure we can make the appropriate investments in our clinical pipeline and further technology development."

"We are determined to unlock the value of Tumor Treating Fields therapy across a variety of solid tumor indications," said Bill Doyle, Novocure’s Executive Chairman. "Our teams continue to make progress enrolling patients in randomized, phase 3, pivotal trials in brain metastases, lung cancer, pancreatic cancer and ovarian cancer, and in our phase 2 pilot study in liver cancer. If approved, the indications in our late-stage pipeline will create a more than 20-fold increase in our U.S. addressable market."

Third quarter 2019 operating statistics and financial update

There were 2,751 active patients at September 30, 2019, representing 22% growth versus September 30, 2018, and one percent growth versus June 30, 2019. The increase in active patients was driven primarily by the ongoing benefit from continued growth in Optune prescriptions for patients with newly diagnosed GBM and by prescription growth in EMEA and Japan.

In the United States, there were 1,860 active patients at September 30, 2019, representing 16% growth versus September 30, 2018.
In Germany and other EMEA markets, there were 731 active patients at September 30, 2019, representing 26% growth versus September 30, 2018.
In Japan, there were 160 active patients at September 30, 2019, representing 132% growth versus September 30, 2018.
Additionally, 1,319 prescriptions were received in the three months ended September 30, 2019, representing six percent growth compared to the same period in 2018, and a three percent decrease compared to the three months ended June 30, 2019. The number of prescriptions for patients with newly diagnosed GBM continued to grow. In the three months ended September 30, 2019, 1,076 prescriptions were received for patients with newly diagnosed GBM, 82% of the total.

In the United States, 917 prescriptions were received in the three months ended September 30, 2019, representing one percent growth to the same period in 2018.
In Germany and other EMEA markets, 318 prescriptions were received in the three months ended September 30, 2019, representing ten percent growth compared to the same period in 2018.
In Japan, 84 prescriptions were received in the three months ended September 30, 2019, representing 75% growth compared to the same period in 2018.
For the three months ended September 30, 2019, net revenues were $92.1 million, representing 42% growth versus the same period in 2018. Revenue growth was primarily driven by an increase of 499 active patients in our currently active markets, representing 22% growth, and a sustained improvement in the net revenues booked per active patient.

Cost of revenues was $22.9 million compared to $18.9 million for the same period in 2018, representing an increase of 21%. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients partially offset by a reduction in the cost of goods per active patient driven by ongoing efficiency initiatives and scale. Gross margin was 75% compared to 71% for the same period in 2018.

Research, development and clinical trials expenses were $18.8 million compared to $13.1 million for the same period in 2018, representing an increase of 44%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal trials and an increase in costs associated with medical affairs, regulatory matters and engineering.

Sales and marketing expenses were $23.8 million compared to $19.1 million for the same period in 2018, representing an increase of 25%. This was primarily due to increased marketing expenses and personnel costs to support our growing commercial business.

General and administrative expenses were $22.7 million compared to $18.9 million for the same period in 2018, representing an increase of 20%. This was primarily due to an increase in personnel costs and an increase in professional services.

Net income was $1.9 million, or $0.02 per share, compared to net loss of $11.7 million for the same period in 2018, or $0.13 per share.

At September 30, 2019, we had $208.0 million in cash and cash equivalents and $104.6 million in short-term investments, for a total balance of $312.6 million in cash, cash equivalents and short-term investments.

Anticipated clinical and regulatory milestones

Zai Lab initiation of phase 2 pilot trial in gastric cancer (2019)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2019 financial results at 8 a.m. EDT today, Thursday, October 31, 2019. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1178711.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website (www.novocure.com/investor-relations), as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.