On May 3, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) reported results for the quarter ended March 31, 2018 (Press release, Teva, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346698 [SID1234526094]).

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Mr. Kåre Schultz, Teva’s President and CEO, said "2018 is off to a solid start. Our restructuring program is proceeding well, and we are on track to meet our cost reduction targets of $1.5 billion in 2018 and $3.0 billion by the end of 2019. During this quarter, our strong cash flow allowed us to continue to reduce our outstanding debt, and together with our recent debt issuance and covenant amendment, has placed Teva on a more stable financial footing. We have also benefited this quarter from the durability of COPAXONE and a steady flow of generic launches in the U.S. Our strong first quarter performance, along with our confidence in executing the restructuring program, gives us a solid foundation to raise our guidance for the year."

First Quarter 2018 Consolidated Results

Revenues in the first quarter of 2018 were $5.1 billion, a decrease of 10%, or 15% in local currency terms, compared to the first quarter of 2017, mainly due to adverse market dynamics in the U.S. generics market, generic competition to COPAXONE and loss of revenues following our divestment of certain products and discontinuation of certain activities.

Exchange rate differences between the first quarter of 2018 and the first quarter of 2017 positively impacted our revenues by $240 million, our GAAP operating income by $37 million and our non-GAAP operating income by $46 million.

GAAP gross profit was $2.3 billion in the first quarter of 2018, down 17% compared to the first quarter of 2017. GAAP gross profit margin was 46.4% in the first quarter of 2018, compared to 50.2% in the first quarter of 2017.

Non-GAAP gross profit was $2.7 billion in the first quarter of 2018, a decline of 18% from the first quarter of 2017. Non-GAAP gross profit margin was 52.3% in the first quarter of 2018, compared to 56.9% in the first quarter of 2017. The decrease in gross profit margin, on both a GAAP and a non-GAAP basis, was mainly the result of lower profitability in our North America segment due to lower COPAXONE sales and adverse market dynamics in the U.S. generics market.

Research and Development (R&D) expenses for the first quarter of 2018 were $317 million, down 27% compared to the first quarter of 2017. R&D expenses excluding equity compensation expenses and other R&D expenses were $289 million, or 5.7% of quarterly revenues in the first quarter of 2018, compared to $420 million, or 7.4%, in the first quarter of 2017. The decrease in R&D expenses primarily resulted from pipeline optimization, project terminations, phase 3 studies that ended and related headcount reductions.

Selling and Marketing (S&M) expenses in the first quarter of 2018 were $771 million, a decrease of 20% compared to the first quarter of 2017. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $715 million, or 14.1% of revenues, in the first quarter of 2018, compared to $894 million, or 15.8% of revenues, in the first quarter of 2017. The decrease was mainly due to cost reduction and efficiency measures as part of the restructuring plan.

General and Administrative (G&A) expenses in the first quarter of 2018 were $329 million, a decrease of 10% compared to the first quarter of 2017. G&A expenses excluding equity compensation expenses and other items were $322 million in the first quarter of 2018, or 6.4% of quarterly revenues, compared to $353 million, or 6.2% in the first quarter of 2017. The decrease was mainly due to cost reduction and efficiency measures as part of the restructuring plan.

GAAP other income in the first quarter of 2018 was $203 million, an increase of 182% compared to $72 million in the first quarter of 2017. Non-GAAP other income in the first quarter of 2018 was $110 million, an increase of 53% compared to $72 million in the first quarter of 2017. The increase in other income was primarily the result of higher Section 8 recoveries in Canada and a $93 million net gain related to the divestment of our women’s health business, which was excluded from our non-GAAP results.

GAAP operating income in the first quarter of 2018 was $1.5 billion, compared to $895 million in the first quarter of 2017. Non-GAAP operating income in the first quarter of 2018 was $1.4 billion, a decrease of 11% compared to the first quarter of 2017. GAAP operating margin was 30.0% in the first quarter of 2018 compared to 15.8% in the first quarter of 2017. Non-GAAP operating margin was 28.3% in the first quarter of 2018 compared to 28.7% in the first quarter of 2017.

EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as excluding depreciation expenses) was $1.6 billion in the first quarter of 2018, down 10% compared to $1.8 billion in the first quarter of 2017.

GAAP financial expenses for the first quarter of 2018 were $271 million, compared to $207 million in the first quarter of 2017. Non-GAAP financial expenses were $203 million in the first quarter of 2018, compared to $235 million in the first quarter of 2017. The decrease in our non-GAAP financial expenses was mainly due to an increased gain in our hedging and derivatives activities and lower interest expenses resulting from reduced overall debt, partially offset by an increase in interest and foreign exchange rates.

GAAP income taxes for the first quarter of 2018 were $46 million, or 4%, on pre-tax income of $1.3 billion. In the first quarter of 2017, GAAP income taxes were $54 million, or 8%, on pre-tax income of $688 million. Our tax rate for the first quarter of 2018 was mainly affected by one-time legal settlements and divestments that had a low corresponding tax effect. Non-GAAP income taxes for the first quarter of 2018 were $211 million on pre-tax non-GAAP income of $1.2 billion, for a quarterly tax rate of 17%. Non-GAAP income taxes in the first quarter of 2017 were $240 million on pre-tax non-GAAP income of $1.4 billion, for a quarterly tax rate of 17%.

GAAP net income attributable to ordinary shareholders and GAAP diluted EPS in the first quarter of 2018 were $1.1 billion and $1.03, respectively, compared to $580 million and $0.57, respectively, in the first quarter of 2017. Non-GAAP net income attributable to ordinary shareholders and non-GAAP diluted EPS in the first quarter of 2018 were $954 million and $0.94, respectively, compared to $1.1 billion and $1.06 in the first quarter of 2017.

For the first quarter of 2018, the weighted average outstanding shares for the fully diluted EPS calculation on both a GAAP and a non-GAAP basis was 1,020 million, compared to 1,017 million on a GAAP and non-GAAP basis for the first quarter of 2017. Additionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 64 million (including shares that may be issued due to unpaid dividends to date) for the three months ended March 31, 2018 and 59 million for the three months ended March 31, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on EPS.

Non-GAAP information: Net non-GAAP adjustments in the first quarter of 2018 were positive $101 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:

Impairments of $612 million, mainly a goodwill impairment related to Rimsa, impairment of intangible assets of product rights and IPR&D assets related to the Actavis Generics acquisition, as well as impairment for closure of manufacturing sites and other fixed assets. The impairment also includes $56 million related to a plant located in India in connection with the termination of PGT Healthcare joint venture.
Impairments of equity investments of $94 million due to termination of PGT Healthcare joint venture.
Amortization of purchased intangible assets totaling $310 million, of which $264 million is included in cost of goods sold and the remaining $46 million in S&M expenses;
Restructuring expenses of $247 million;
Financial expenses of $68 million mainly related to early redemption fees;
Other non-GAAP items of $104 million;
Divestment benefit of $93 million related to capital gain from the sales of our women health business;
Tax benefit of $165 million; and
Benefits from legal settlements of $1.3 billion mainly related to the Allergan working capital adjustments, the Rimsa settlement and the reversal of the carvedilol judgement against Teva.
Teva believes that excluding such items facilitates investors’ understanding of its business. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP figures. Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operations during the first quarter of 2018 was $1.5 billion, compared to $0.1 billion in the first quarter of 2017. The increase was mainly due to proceeds from the working capital adjustment with Allergan and the legal settlement with Rimsa, compared to payments made to the SEC and DOJ in connection with the FCPA resolution in the first quarter of 2017.

Free cash flow, excluding net capital expenditures and beneficial interest collected in exchange for securitized trade receivables, was $1.9 billion in the first quarter of 2018, compared to $0.3 billion in the first quarter of 2017. The increase was mainly due to the increase in cash flow from operations as well as lower net capital expenditures investments and higher securitized account receivables.

As of March 31, 2018, our total gross debt was $30.8 billion, compared to $32.5 billion as of December 31, 2017. The decrease was mainly due to $6.5 billion in debt prepayments, partially offset by our March 2018 issuance of an aggregate principal amount of $4.4 billion of senior notes, as well as exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2018 was 4%, compared to 11% as of December 31, 2017.

Segment Results for the First Quarter 2018

Due to the organizational changes announced in November 2017, our financial results are now being reported under new segments. Our new reportable segments are:

a) North America segment, which includes the United States and Canada.

b) Europe segment, which includes the European Union and certain other European countries.

c) Growth Markets segment, which includes all countries other than those in our North America and Europe segments.

In addition to these three segments, we have other activities, primarily our API third party manufacturing business and certain contract manufacturing services.

Segment profit is comprised of gross profit for the segment, less R&D, S&M, G&A expenses and other income related to each segment. Segment profit does not include amortization and certain other items.

North America Segment

Our North America segment includes the United States and Canada.

The following table presents revenues, expenses and profit for our North America segment for the three months ended March 31, 2018 and 2017:

Generic products revenues in our North America segment in the first quarter of 2018 decreased by 23% to $1.1 billion, compared to the first quarter of 2017, mainly due to lower volumes and price erosion.

In the first quarter of 2018, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 584 million total prescriptions, representing 15% of total U.S. generic prescriptions according to IQVIA data.

COPAXONE revenues in our North America segment in the first quarter of 2018 decreased by 40% to $476 million compared to the first quarter of 2017, mainly due to generic competition in the United States. COPAXONE revenues in the United States were $462 million in the first quarter of 2018.

BENDEKA and TREANDA combined revenues in our North America segment in the first quarter of 2018 increased by 16% to $181 million, compared to the first quarter of 2017, mainly due to higher volumes resulting from supply stabilization.

ProAir revenues in our North America segment in the first quarter of 2018 increased by 7% to $130 million, compared to the first quarter of 2017, mainly due to higher volumes.

QVAR revenues in our North America segment in the first quarter of 2018 increased by 27% to $107 million, compared to the first quarter of 2017. We launched QVAR RediHaler in the first quarter of 2018. The increase in sales in the first quarter of 2018 was mainly due to slightly higher wholesaler stocking for all QVAR family products in connection with the launch. QVAR maintained its second-place position in the inhaled corticosteroids category in the United States.

AUSTEDO revenues in our North America segment in the first quarter of 2018 were $30 million. AUSTEDO was approved by the FDA for the treatment of chorea associated with Huntington disease and was launched in the United States in April 2017. In August 2017, the FDA approved AUSTEDO for the treatment of tardive dyskinesia.

Distribution revenues in our North America segment which are generated by Anda increased by 12% to $331 million in the first quarter of 2018, compared to the first quarter of 2017, mainly due to the severe cold, cough and influenza season in the first quarter of 2018, which increased demand for certain medicines.

North America Gross Profit

Gross profit from our North America segment in the first quarter of 2018 was $1.4 billion, a decrease of 31% compared to $2.1 billion in the first quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products.

Gross profit margin for our North America segment in the first quarter of 2018 decreased to 56.6%, compared to 64.2% in the first quarter of 2017. This decrease was mainly due to lower COPAXONE revenues and continued price erosion of generic products.

North America Profit

Profit from our North America segment in the first quarter of 2018 was $915 million, a decrease of 30% compared to $1.3 billion in the first quarter of 2017. The decrease was mainly due to lower revenues due to generic competition for COPAXONE and continued price erosion in the U.S. generics market, partially offset by cost reduction and higher other income.

Europe Segment

Our Europe segment includes the European Union and certain other European countries.

Segment profit does not include amortization and certain other items. The data presented for prior periods have

been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018.

Revenues from our Europe segment in the first quarter of 2018 were $1.4 billion, an increase of $101 million or 8%, compared to the first quarter of 2017. In local currency terms, revenues decreased by 6%, mainly due to the loss of revenues from the closure of our distribution business in Hungary and the sale of our women’s health business, partially offset by new generic product launches.

Revenues by Major Products and Activities

Generic products revenues in our Europe segment in the first quarter of 2018, including OTC products, increased by 17% to $997 million, compared to the first quarter of 2017. In local currency terms, revenues increased by 2%, mainly due to new product launches and volume growth in OTC, partially offset by price reductions.

COPAXONE revenues in our Europe segment in the first quarter of 2018 increased by 1% to $153 million, compared to the first quarter of 2017. In local currency terms, revenues decreased by 13%, mainly due to price reductions resulting from the entry of generic competition.

Respiratory products revenues in our Europe segment in the first quarter of 2018 increased by 35% to $113 million, compared to the first quarter of 2017. In local currency terms, revenues increased by 18%, mainly due to the launch of BRALTUS in 2017.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2018 was $797 million, an increase of 9% compared to $734 million in the first quarter of 2017. The increase was mainly due to the positive impact of currency fluctuations, partially offset by the loss of revenues from the sale of our women’s health business.

Gross profit margin for our Europe segment in the first quarter of 2018 increased to 55.3%, compared to 54.7% in the first quarter of 2017. This increase was mainly due to the closure of our distribution business in Hungary, partially offset by other production costs.

Europe Profit

Profit from our Europe segment in the first quarter of 2018 was $377 million, an increase of 41% compared to $268 million in the first quarter of 2017. The increase was mainly due to higher revenues as well as cost reductions and efficiency measures as part of the restructuring plan.

Growth Markets Segment

Our Growth Markets segment includes all countries other than those in our North America and Europe segments. The key markets in this segment are Japan, Russia and Israel.

Segment profit does not include amortization and certain other items. The data presented for prior periods have

been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018.

Revenues from our Growth Markets segment in the first quarter of 2018 were $750 million, an increase of $32 million, or 4%, compared to the first quarter of 2017. In local currency terms, revenues were flat compared to the first quarter of 2017, mainly due to higher sales in Israel, Japan and Russia, partially offset by the effect of the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.

Revenues by Major Products and Activities

Generic products revenues in our Growth Markets segment in the first quarter of 2018, which includes OTC products, were flat compared to the first quarter of 2017. In local currency terms, revenues decreased by 3%, mainly due to the effect of the deconsolidation of our subsidiaries in Venezuela.

COPAXONE revenues in our Growth Markets segment in the first quarter of 2018 decreased by 24% to $16 million, compared to the first quarter of 2017. In local currency terms, revenues decreased by 20%.

Distribution revenues in our Growth Markets segment in the first quarter of 2018 increased by 22%, compared to the first quarter of 2017. In local currency terms, revenues increased by 13%.

Growth Markets Gross Profit

Gross profit from our Growth Markets segment in the first quarter of 2018 was $313 million, an increase of 7% compared to $292 million in the first quarter of 2017. The increase was mainly due to higher revenues in Japan, including Azilect approval payment from Takeda, and Israel, partially offset by the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.

Gross profit margin for our Growth Markets segment in the first quarter of 2018 increased to 41.7%, compared to 40.7% in the first quarter of 2017. This increase was mainly due to higher gross profit in Japan, partially offset by the deconsolidation of our subsidiaries in Venezuela.

Growth Markets Profit

Profit from our Growth Markets segment in the first quarter of 2018 was $122 million, compared to $40 million in the first quarter of 2017. The increase was mainly due to higher revenues, as well as cost reductions and efficiency measures as part of the restructuring plan.

During the fourth quarter of 2017, we deconsolidated our subsidiaries in Venezuela from our financial results. Consequently, results of operations of our subsidiaries in Venezuela are not included in our financial results for the first quarter of 2018.

Other Activities

We have other sources of revenues, primarily our API manufacturing business and certain contract manufacturing services. These other activities are not included in our North America, Europe or Growth Markets segments.

Our revenues from other activities in the first quarter of 2018 decreased by 2.6% to $342 million. In local currency terms, revenues decreased by 8%, mainly due to lower API sales to third parties.

API sales to third parties in the first quarter of 2018 decreased by 9% to $179 million. In local currency terms, revenues decreased by 10%, mainly due to the timing of certain shipments in the first quarter of 2018.

R&D Pipeline Update

fremanezumab – We do not expect to receive FDA approval on our Biologics License Applications (BLA) for fremanezumab on the mid-June PDUFA date. We are engaged in a constructive dialogue with the FDA in close collaboration with our partner Celltrion, Inc. We expect an FDA pre-approval inspection to take place in the coming months and to receive FDA approval and launch before the end of 2018.

These estimates reflect management’s current expectations for Teva’s performance in 2018. Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors. In addition, the non-GAAP measures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects.

See "Non-GAAP Financial Measures" below.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Thursday, May 3, 2018 at 8:00 a.m. ET to discuss its first quarter 2018 results and overall business environment. A question & answer session will follow.

In order to participate, please dial the following numbers (at least 15 minutes before the scheduled start time):

United States 1-866-254-0808

International 44 (0) 1452 541003

for a list of other international toll-free numbers, click here.

Passcode: 9496209

A live webcast of the call will also be available on Teva’s website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website. The replay can also be accessed until May 31, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222 or International 44(0)1452550000; passcode: 9496209.

On May 3, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for first-quarter 2018, and provided an update on the Company’s commercial products and development programs (Press release, TESARO, MAY 3, 2018, View Source [SID1234526093]).

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"2018 is off to an excellent start for TESARO, as ZEJULA continues to penetrate the recurrent ovarian cancer market," said Lonnie Moulder, CEO of TESARO. "We expect to expand the market for ZEJULA to the front-line setting with PRIMA, our Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status, with data expected late next year. In March, data presented from our TOPACIO trial of ZEJULA in combination with an anti-PD-1 antibody surpassed historical monotherapy benchmarks in difficult-to-treat platinum-resistant and refractory ovarian cancer patients, and we look forward to presentations from both the ovarian and triple-negative breast cancer cohorts of TOPACIO at ASCO (Free ASCO Whitepaper). Our immuno-oncology pipeline is advancing quickly and we are on track to submit a biologic license application for TSR-042, our anti-PD-1 antibody, for patients with MSI-high tumors in 2019. Enrollment continues in our AMBER trial of TSR-022, our anti-TIM-3 antibody, in combination with TSR-042, and data from this trial in tumor-specific expansion cohorts are expected to be presented at a medical meeting later this year."

Recent Business Highlights

ZEJULA is the most utilized PARP inhibitor among ovarian cancer patients in the U.S., with more than 5,000 patients treated since launch in April 2017. The European launch of ZEJULA continues in Germany.
Enrollment was completed in the Phase 3 PRIMA trial for patients with first-line ovarian cancer regardless of biomarker status. Data from this study are anticipated in late 2019.
Data were presented from the ovarian cancer cohort of the TOPACIO trial of ZEJULA in combination with an anti-PD-1 monoclonal antibody at the Society for Gynecologic Oncology (SGO) Annual Meeting in March. Data demonstrated activity of ZEJULA in combination with an anti-PD-1 antibody in difficult-to-treat types of ovarian cancer.
Results from a retrospective analysis of the NOVA trial were presented at the SGO Annual Meeting, which identified two characteristics, patient body weight and platelet counts, to be predictors of dose modification.
In April, preliminary Phase 1 data from expansion cohorts of the GARNET trial of TSR-042 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Activity of TSR-042 monotherapy was demonstrated in patients with MSI-high endometrial cancer and non-small cell lung cancer (NSCLC), with a well-tolerated safety profile comparable to other anti-PD-1 antibodies.
Top-line results from the QUADRA study of ZEJULA monotherapy in fourth-line plus treatment of ovarian cancer were announced in April. This trial successfully achieved its pre-specified primary endpoint and demonstrated activity in patients with fourth or fifth-line HRD-positive ovarian cancer who were PARP inhibitor naïve and platinum sensitive. Additional QUADRA data will be presented at ASCO (Free ASCO Whitepaper) in June.
Phase 2 data from the TOPACIO trial of ZEJULA with an anti-PD-1 for patients with platinum-resistant ovarian cancer or triple-negative breast cancer were accepted for two separate oral presentations at ASCO (Free ASCO Whitepaper).
TSR-042 is in a registration trial (GARNET) for MSI-high tumors. Data are being generated to demonstrate the activity of TSR-042 in multiple tumor types, including lung, breast and ovarian cancer.
Clinical trials are ongoing to evaluate TSR-022 (anti-TIM-3 antibody) and TSR-033 (anti-LAG-3 antibody) in combination with TSR-042.
AMBER: Phase 1 trial of TSR-022 in combination with TSR-042 is enrolling three tumor specific cohorts.
CITRINO: Phase 1 dose-escalation trial of TSR-033 is ongoing to determine dose and schedule for combination with TSR-042.
First Quarter 2018 Financial Results

TESARO reported net product revenue of $50.2 million for the first quarter of 2018, including ZEJULA sales of $48.9 million, compared to $2.1 million for the first quarter of 2017.

Research and development expenses increased to $96.8 million for the first quarter of 2018, compared to $66.1 million for the first quarter of 2017, primarily due to higher manufacturing and clinical development costs associated with ZEJULA, TSR-042, and TSR-022, increased headcount, and research collaborations.

Selling, general and administrative expenses increased to $93.6 million for the first quarter of 2018, compared to $69.3 million for the first quarter of 2017, primarily due to increased sales and marketing headcount and activities to support sales of ZEJULA in the U.S. and launches in Europe.

Operating expenses as described above include total non-cash, stock-based compensation expense of $26.1 million for the first quarter of 2018, compared to $18.4 million for the first quarter of 2017.

Net loss totaled $162.8 million, or ($2.98) per share, for the first quarter of 2018, compared to a net loss of $136.7 million, or ($2.55) per share, for the first quarter of 2017.

As of March 31, 2018, TESARO had approximately $499.0 million in cash and cash equivalents and approximately 54.8 million outstanding shares of common stock.

In the first quarter, TESARO’s cash and cash equivalents balance declined by approximately $144 million. The Company plans to draw $200 million in the second half of 2018 from its available term loan facility, and quarterly declines in cash and cash equivalents are expected to moderate over the course of 2018. TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million.

Key Development Milestones

TESARO intends to achieve the following development milestones:

Ovarian Cancer Franchise:

Report TOPACIO platinum-resistant ovarian cancer data at ASCO (Free ASCO Whitepaper) and confirm with FDA the intended strategy for registering ZEJULA in combination with TSR-042 in platinum-resistant/refractory ovarian cancer in mid-2018
Initiate FIRST, a Phase 3 clinical trial of ZEJULA in combination with TSR-042 in first-line ovarian cancer, in Q2 2018
Report QUADRA data at ASCO (Free ASCO Whitepaper) and define biomarker-focused regulatory strategy in 2H 2018
Report PRIMA data in first-line ovarian cancer maintenance in late 2019
Breast Cancer:

Report TOPACIO triple-negative breast cancer data at ASCO (Free ASCO Whitepaper)
Publish BRAVO data in 2H 2018
Confirm intended registration path for ZEJULA in breast cancer with FDA in mid-2018
Lung Cancer:

Report additional data from lung cancer cohort of the GARNET trial of TSR-042 in NSCLC in 2H 2018
Initial data from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor to be available in 2H 2018
Prostate Cancer:

Janssen anticipates advancing trials of ZEJULA in prostate cancer to support U.S. and EU regulatory filings in 2019
Immuno-oncology Portfolio:

Complete enrollment in the MSI-high cohort of the GARNET trial of TSR-042 to support a biologics license application (BLA) submission to FDA in 2019
Report initial data for the AMBER trial of TSR-022 in combination with TSR-042 in 2H 2018
Initiate assessment of the combination of TSR-033 plus TSR-042 in the CITRINO trial in Q2 2018 and report Phase 1 monotherapy dose-escalation data for TSR-033 in 2H 2018
Advance IND-enabling studies of PD-1/LAG-3 bi-specific antibody (TSR-075)
Today’s Conference Call and Webcast
TESARO will host a conference call to discuss first quarter operating results and provide an update on its commercial products and development programs today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com

On May 3, 2018, MabVax Therapeutics Holdings, Inc. (the "Company") updated and made available its corporate presentation (Presentation, MabVax, MAY 3, 2018, View Source [SID1234526091])

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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

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On May 3, 2018 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, May 10, 2018 to report its first quarter 2018 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, MAY 3, 2018, View Source [SID1234526090]).

Schedule your 30 min Free 1stOncology Demo!
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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!

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international) and refer to conference ID 2967666. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 3, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended March 31, 2018 (Press release, Spectrum Pharmaceuticals, MAY 3, 2018, View Source [SID1234526089]).

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"We had a productive first quarter as we continued to advance our lead pipeline drugs poziotinib and ROLONTIS," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We were honored to have poziotinib data appear in Nature Medicine, be presented at AACR (Free AACR Whitepaper), and announce our strengthened IP with MD Anderson in addition to releasing ROLONTIS topline data. In the next few months, we look forward to announcing important clinical data from both therapies at key scientific meetings."

Clinical Program Update:

Poziotinib, an irreversible tyrosine kinase inhibitor:

The company has initiated a multi-center study which is currently enrolling non-small cell lung cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at leading cancer centers throughout U.S. The study will evaluate objective response rate (ORR) as the primary endpoint, disease control rate (DCR), duration of response (DOR), progression free survival (PFS), quality of life (QOL) and safety as additional endpoints.
An investigator sponsored trial is ongoing at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 mutations in EGFR or HER2. The 50 patient EGFR cohort is fully enrolled.
In an April 2018 Nature Medicine publication, updated data from the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial showed a confirmed objective response rate of 64 percent. As noted in the publication, the median progression-free survival had not been reached, with a median follow up of 6.6 months. The safety profile was consistent with those previously described for poziotinib and other TKIs. The company expects additional data from this study at the World Conference on Lung Cancer, in Toronto (September 23-26, 2018).
Data presented at AACR (Free AACR Whitepaper) in April 2018, demonstrated pre-clinical and early clinical activity of poziotinib in HER2 exon 20 mutant NSCLC, suggesting poziotinib could be a promising agent for the numerous cancer types driven by HER2 exon 20 mutations.
The company is planning a basket trial to study poziotinib in exon 20 mutations across several solid tumors.
The company has entered into an exclusive licensing agreement with MD Anderson which strengthens and extends intellectual property on poziotinib. The filed patents, if granted, will extend until 2037.
ROLONTIS(eflapegrastim), a novel long-acting GCSF:

A registrational Phase 3 study, ADVANCE, was initiated under a special protocol assessment with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia.
The company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in duration of severe neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms. Phase 3 data abstract to be released by American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) followed by an oral presentation at Multinational Association of Supportive Care in Cancer (MASCC) in June 2018.
The company has completely enrolled RECOVER, an international Phase 3 study that has a design similar to ADVANCE.
Spectrum is working toward a pre-BLA meeting with the FDA to ensure alignment in preparation for a planned Q4 BLA submission.
Financial Guidance

The company has also raised guidance for 2018. Expected 2018 revenue will be between $95 million to $115 million, up from previously projected revenue of $90 million to $110 million. Additionally, the company expects its current cash and marketable securities to be sufficient to fund operations into 2020.

Three-Month Period Ended March 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $28.1 million in the first quarter of 2018. Product sales in the first quarter included: FOLOTYN (pralatrexate injection) net sales of $12.7 million, EVOMELA (melphalan) for injection net sales of $8.1 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.0 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $0.6 million.

Spectrum recorded net loss of $15.8 million, or $0.16 per basic and diluted share in the three-month period ended March 31, 2018, compared to net loss of $23.5 million, or $0.30 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $17.9 million in the quarter, as compared to $14.8 million in the same period in 2017. Selling, general and administrative expenses were $24.1 million in the quarter, compared to $19.1 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $14.7 million, or $0.15 per basic and diluted share in the three-month period ended March 31, 2018, compared to non-GAAP net loss of $11.4 million, or $0.14 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $17.1 million, as compared to $14.3 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $20.4 million, as compared to $15.7 million in the same period in 2017.

Conference Call

Thursday, May 3, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 8765418

International: (973) 796-5077, Conference ID# 8765418

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 3, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.