Takeda announces its results for the second quarter of fiscal year 2018

On November 2, 2018 Takeda Pharmaceutical Company Limited (TOKYO: 4502) (Press release, Takeda, NOV 2, 2018, View Source [SID1234530660]):

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+4.2% growth in underlying revenue driven by growth drivers, with growth in each region

Underlying sales increased by + 4.2%, with Takeda’s growth drivers (gastroenterology, oncology, neuroscience and emerging markets) continuing to grow +9.8 %.
The key products Entyvio (+ 33.1%) and Ninlaro (+ 38.0%) contributed significantly to the growth in sales, as well as the products acquired from Ariad in 2017. Each region achieved positive growth compared to last year (USA + 9.2%, Japan + 4.1%, Europe & Canada + 4.3%, Emerging Markets + 2.4%).
Reported revenues decreased by -0.1%. Although our growth drivers maintained their strong growth, foreign currency exchange rates (-1.0 pp) and disposals (-3.2 pp) had a negative impact. The impact of the divestments included the sale of additional products to the Teva JV during the 2017 fiscal year, as well as Multilab and Techpool during the fiscal year 2018.
Underlying core earnings of + 31.8% with a margin of + 5.1 pp resulting from strict OPEX discipline

Earnings from underlying core businesses increased +31.8%, reflecting revenue growth and a 5.1pp margin increase, of which two-thirds (3.3ppm) ) were stimulated by OPEX improvements. This was the result of the global OPEX initiative fully integrated into working methods at Takeda.
Reported operating profit fell 26.6%. It was impacted by two strong non-recurring gains recorded in fiscal 2017: the sale of Wako shares for 106.3 billion yen and the sale of additional products to the Teva JV. In addition, Takeda recorded non-recurring expenses for fiscal year 2018 related to the proposed acquisition of Shire. Excluding these non-recurring items, operating income increased by +64.5%.
Core EPS was up + 32.7% and reported EPS decreased 26.9% to 162 yen per share, impacted by disposals and Shire-related costs.
The product pipeline has reached several milestones in the first half of fiscal year 2018

Maintenance of multiple myeloma after a Ninlaro stem cell transplant (TOURMALINE-MM3 study), Alukbris ALK + first line metastatic non-small cell lung cancer (ALTA-1L study), Adcetris first-line CD30 + T cell peripheral lymphoma (ECHELON-2 study) and the subcutaneous formulation in Entyvio ulcerative colitis (VISIBLE 1 study) all met their primary endpoints.
Seven new molecular entities have been integrated into the Phase 1 pipeline since April 2018.
Non-core asset disposal plan is on track

Free cash flow from operations since the beginning of the year decreased by -29.7% primarily as a result of the impact of the sale of additional products to the Teva JV during the 2017 fiscal year.
The sale of securities and real estate generated 44.2 billion yen in cash and the sale of non-core activities Techpool and Multilab generated an additional 27.2 billion yen.
The net debt / EBITDA ratio is 1.7x, an improvement of 1.8x for the fourth quarter of fiscal year 2017 and 2.7x for the fourth quarter of fiscal year 2016.
Christophe Weber, President and Chief Executive Officer, commented:

"Strategic priorities and a high quality of execution led to a solid performance in the first half of fiscal year 2018, as we are committed to meeting our key priorities to increase the portfolio, strengthen the pipeline, boost profitability. Our growth drivers contribute significantly to both earnings and earnings, and I am pleased to report that two-thirds of the 510 basis points of underlying core earnings margin improvement can be explained by the discipline in terms of costs following the global OPEX initiative.
In the first half of the year, we also achieved several important financial and regulatory milestones towards the proposed acquisition of Shire plc. I would like to emphasize that Takeda’s current strategy is working and that Takeda’s board of directors, Takeda’s management team and I are confident that the acquisition of Shire will allow Takeda to significantly accelerate the transformation. of the company to become a global leader in biopharmaceutical, R & D-based, values-based, headquartered in Japan. "

Basic earnings represent adjusted net income to exclude the tax expense, our share of capital gains or losses accounted for by the equity method, financial income and expenses, other costs and income. operating, amortization and impairment of intangible assets associated with revenue and other items that management perceives as unrelated to our core business, such as the impact of purchase accounting and transaction costs.

Underlying growth compares two periods (quarters or years) of financial results on a common basis and is used by management to evaluate the business. These financial results are calculated in constant currencies and exclude the impacts of divestitures and other amounts that are exceptional items, unusual or unrelated to our ongoing operations.

Attributable to the owners of the company.

Takeda Upgrades Velcade’s Full-Year Forecast, Dynamics of Growth Factors and OPEX Discipline

Upward revisions to underlying guidelines and reported forecasts.

Underlying guidance for fiscal year 2018: Underlying earnings guidance increased

Previous projections (% growth)
(May 14, 2018) Revised Projections (% Growth)
(October 31, 2018)
Underlying turnover Low single digit growth rate Low single digit growth rate
Earnings from underlying core businesses High single digit growth Average growth%
Underlying basic EPS Low double-digit growth rate High growth (around mid-20s)
Annual dividend per share 180 yen 180 yen
Projections maintain an additional competitor with no therapeutic equivalence in Velcade with the launch of subcutaneous and intravenous administration in the United States in March 2019, an increase of 35.5 billion yen compared to previous projections (Figure 1). global business for fiscal 2017: 129.6 billion yen, fiscal 2018: 111.0 billion yen) *
Increased underlying core earnings margin in the upper range of + 100-200bps.
These underlying projections exclude the estimated financial impact of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc.
* (application of the constant exchange rate based on the rate of the fiscal year 2018)

The revised projections in the table above include the costs incurred in the first half of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc (pre-tax earnings impact: 19.8 billion yen, net profit for the impact on the year: 16.5 billion yen); however, these do not include anticipated Shire costs for the second half of the fiscal year. In addition, the projections do not include any expected Shire earnings in the event that the closing of the acquisition is finalized during fiscal year 2018.
Takeda expects the share of Shire-related costs anticipated for fiscal year 2018 to be between 40 billion yen and 60 billion yen. This does not include integration costs, interest expense and other financial charges, since the magnitude of the impact of fiscal year 2018 will be related to the closing period of the transaction.
(Reference)

A revised financial projection that excludes costs incurred in the first half of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc is presented below. Previous projections for May 14, 2018 do not include expenses related to Shire.

Forecasts excluding the estimated financial impact of the proposed acquisition of Shire will be announced by Takeda as soon as a reasonable assumption has been confirmed.
For more information on the results of the first half of Takeda’s fiscal year 2018, as well as other financial information, please visit View Source

Epizyme Reports Third Quarter 2018 Financial Results and Tazemetostat Progress

On November 2, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, today reported financial results for the third quarter of 2018 and provided updates on its tazemetostat clinical development program (Press release, Epizyme, NOV 2, 2018, View Source [SID1234530635]). Tazemetostat is a first-in-class, selective, orally available EZH2 inhibitor, in development for hematologic malignancies and solid tumor cancers, as a monotherapy and combination agent.

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"2018 has been a year of important milestones. We have seen clinically meaningful activity with tazemetostat in patients with follicular lymphoma, both with and without EZH2 activating mutations, and are pleased that enrollment of patients with EZH2 activating mutations has re-opened in the U.S. With this, we remain on track with our previous guidance of completing enrollment in our Phase 2 study by the end of the year," said Robert Bazemore, president and chief executive officer of Epizyme. "Tazemetostat has also demonstrated clinically meaningful activity, with both durable objective responses and encouraging overall survival, in patients with epithelioid sarcoma, a difficult-to-treat rare cancer. Based on these positive data, we are confident in our planned NDA submission for epithelioid sarcoma in the first half of 2019. With our highly experienced management team, we are positioned to lead the company through several near-term inflection points and the commercial launch of tazemetostat, if approved. I am enthusiastic about our future and ability to execute our mission of rewriting treatment for people with cancer."

Tazemetostat Clinical Program Updates

Enrollment of Follicular Lymphoma Patients with EZH2 Activating Mutations to be Completed by End of 2018: Clinical sites in the U.S. have resumed screening patients with follicular lymphoma with EZH2 mutations in the company’s ongoing Phase 2 study. The company is on track to complete enrollment of this cohort by the end of 2018, in line with previous guidance. Enrollment of patients with wild-type EZH2 was completed in 2017. Epizyme plans to continue engaging with FDA to refine its registration strategy in follicular lymphoma, and provide an update on its plans in early 2019.

Positive Data in Epithelioid Sarcoma Support Planned NDA Submission: Epizyme presented positive interim data from the fully enrolled epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat during the European Society for Medical Oncology

(ESMO) 2018 Congress in October. Data as of August 21, 2018 from the 62 patients enrolled showed that oral, twice daily administration of tazemetostat resulted in durable objective responses and encouraging clinically meaningful overall survival in both treatment-naive patients and patients who had been previously treated with an anticancer therapy. In addition, tazemetostat was generally well-tolerated with low rates of discontinuations due to treatment-related adverse events. The company is on-track to submit its New Drug Application for tazemetostat in epithelioid sarcoma in the first half of 2019, with a path to submission for accelerated approval.

Business Updates

In October 2018, Epizyme announced the closing of its underwritten public offering of 9,583,334 shares of its common stock at a public offering price of $9.00 per share, which includes 1,250,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price, less the underwriting discount. The aggregate gross proceeds to Epizyme from the offering, before deducting underwriting discounts and offering expenses, are $86.25 million.

Third Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $180.8 million as of September 30, 2018, which compares to $307.2 million as of September 30, 2017.

R&D Expenses: Research and development (R&D) expenses were $27.0 million for the third quarter of 2018, which compares to $28.7 million for the third quarter of 2017. The decrease was primarily due to decreased clinical trial expenses and discovery stage research expenses offset by an increase in tazemetostat manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $11.5 million for the third quarter of 2018, which compares to $9.3 million for the third quarter of 2017. The increase was primarily due to increases in pre-commercialization activities and in personnel related expenses.

Net Loss: Net loss was $37.5 million, or $0.54 per share, for the third quarter of 2018, which compares to a net loss of $37.6 million, or $0.63 per share, for the third quarter of 2017.

Financial Guidance

Following its October financing, Epizyme expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the first quarter of 2020.

Due to Epizyme’s recent update during ESMO (Free ESMO Whitepaper), the company will not host a conference call on these results.

About the Tazemetostat Clinical Trial Program

Tazemetostat, a potent, selective, orally available, first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma; and combination studies in diffuse large B-cell lymphoma and non–small cell lung cancer.

OncoSec Announces Preliminary Data from KEYNOTE-695 Study Accepted for Late-Breaking Presentation at SITC Annual Meeting

On November 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that preliminary clinical and immunological data from its ongoing KEYNOTE-695 study, a global, multicenter, registration-directed Phase 2b trial of TAVO in combination with KEYTRUDA for the treatment of metastatic melanoma, were accepted for a late-breaking Poster Presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 7-11, 2018 (Press release, OncoSec Medical, NOV 2, 2018, View Source [SID1234530633]).

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The details of the Poster Presentation are as follows:

Presentation Title: Initial report of intratumoral tavokinogene telseplasmid with pembrolizumab in advanced melanoma: an approach designed to convert PD-1 antibody progressors into responders.
Author: Atkinson, et. al.
Poster Number: P717
Presentation date: Friday, November 9 and Saturday, November 10, 2018

The late-breaking abstract titles can be found on the conference website here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Stemline Therapeutics Announces Four ELZONRIS Presentations, Including an Oral Presentation, at Upcoming ASH Meeting

On November 2, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp; SL-401), a novel targeted therapeutic directed to CD123, will be featured in four presentations, including an oral presentation, at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 1-4, 2018 in San Diego, CA (Press release, Stemline Therapeutics, NOV 2, 2018, View Source [SID1234530630]).

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Additionally, the Company is hosting an investor/analyst event on December 3, 2018 and plans to provide updates on the progress of its pre-commercial activities, disease awareness campaign, and market expansion efforts.

Details on the ASH (Free ASH Whitepaper) presentations are as follows:

BPDCN – Oral Presentation
Title: Results of Pivotal Phase 2 Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 765
Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: New Treatment Strategies
Date/Time: Monday, December 3, 2018 3:15 PM PT
Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F

Chronic Myelomonocytic Leukemia (CMML)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML)
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 1821
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Myelofibrosis (MF)
Title: Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 1773
Session: 634. Myeloproliferative Syndromes: Clinical: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM–8:15 PM PT
Location: San Diego Convention Center, Hall GH

Tagraxofusp + Hypomethylating Agents: Chronic Myelomonocytic Leukemia (CMML)
Title: Evaluation of Combination Tagraxofusp (SL-401) and Hypomethylating Agent (HMA) Therapy for the Treatment of Chronic Myelomonocytic Leukemia (CMML)
Presenter: Aishwarya Krishnan, Memorial Sloan Kettering Cancer Center
Abstract: 1809
Session: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I
Date/Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM PT
Location: San Diego Convention Center, Hall GH

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We are honored that ASH (Free ASH Whitepaper) has selected the BPDCN pivotal results for oral presentation. This selection underscores the heightening awareness of the disease – BPDCN, the target – CD123, and the clinical impact of the drug candidate – ELZONRIS. In addition, our regulatory team continues to work diligently in an effort to make ELZONRIS available to patients as quickly as possible, and our commercial team continues to execute on our broad-based pre-launch initiatives. This includes the build-out of our sales, marketing and reimbursement teams as well as continuing to advance our disease awareness campaign. In parallel, we are excited to present updated clinical data from our ongoing clinical trials in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF). Based on these data, we are enthusiastic about our plans to implement pivotal trials, or cohorts, in these devastating malignancies."

About BPDCN
Please visit the BPDCN disease awareness booth at ASH (Free ASH Whitepaper) 2018 (#205) and the website: www.bpdcninfo.com.

Advaxis Provides Update on Clinical Pipeline

On November 2, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that it will be continuing its ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) (Press release, Advaxis, NOV 2, 2018, View Source [SID1234530629]).

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The current trial design has a planned sample size of 450 subjects to maintain adequate statistical power over a broader range of survival outcomes, as well as a pre-planned interim analysis (IA) of safety and efficacy. However, the Company is evaluating the possibility of accelerating the IA timeline and establishing a more stringent futility boundary. The Company anticipates that over the next couple of months it will finalize the redesign of the trial and review it with the U.S. Food and Drug Administration (FDA). During this time, the study is continuing to enroll patients under its current design, which is being conducted under a Special Protocol Assessment with the FDA.

"Based on discussions over the past several months with a number of experts in the field regarding our AIM2CERV trial, we have become increasingly optimistic about the prospects of this study. We believe that continuing to invest in this study, along with certain other product candidates, provides us with a diversified portfolio across drug constructs, cancer types and stages of development," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We believe this approach affords the best opportunity to demonstrate the therapeutic potential of drug candidates generated from our unique and proprietary Lm platform." He concluded, "The redesign of AIM2CERV with an earlier interim analysis would allow us to alter course or, if necessary, stop the study, depending on the results. If the FDA accepts our proposed revisions, we anticipate having a recommendation based on the interim analysis from the data monitoring committee as early as the fourth quarter of 2020."

In addition to continuing its AIM2CERV trial for AXAL, the Company plans to initiate an investigator-sponsored trial with a major research center in head and neck cancer in early 2019. The Company is also continuing to follow subjects in its Phase 1/2 study of ADXS-PSA in combination with KEYTRUDA in metastatic castration-resistant prostate cancer. Intriguing early data from 37 patients in this study presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) earlier this year showed an improvement in survival in subjects with PSA declines from baseline of 50% or greater (~19% of all treated subjects). The Company expects to provide an update on survival rates along with correlative biomarker work in the first quarter of 2019.

To maximize the efficient use of clinical funding resources, the Company will not continue enrollment in its Phase 1/2 study of AXAL in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer, and will not initiate its ADVANCE study for the treatment of women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix.

The Company’s Phase 1 dose-escalation study of ADXS-NEO expressing personalized tumor antigens in subjects with various solid tumors, in collaboration with Amgen, is continuing to enroll subjects and Advaxis anticipates providing safety, tolerability and immune correlative data from the first two cohorts in the first half of 2019.

The Company also continues to progress its ADXS-HOT 503 drug candidate, expressing public (shared) tumor antigens both as monotherapy and in combination with KEYTRUDA for the treatment of non-small cell lung cancer (NSCLC). The Company plans to have the first subject enrolled in this Phase 1/2 study by the end of 2018 with an anticipated readout of safety, tolerability and immune correlative data from the first cohort in the first half of 2019. The Company’s clinical testing of ADXS-HOT in prostate cancer and bladder cancer will continue as the next areas of focus. Initiation of clinical trials in each of these cancers will be delayed until early 2020 to ensure adequate funding for the Company’s other programs.

In support of these programs, Advaxis anticipates its annual cash usage to be approximately $45 million, which was reduced from an annual cash usage of approximately $80 million earlier this year.

The Company will be holding a conference call today, November 2, 2018, at 11:00 a.m. Eastern time to provide an update on its clinical programs.

Conference Call & Webcast Information
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 1538717
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning today two hours after the close of the conference call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 1538717. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.