Teva Reports Fourth Quarter and Full Year 2018 Financial Results

On February 13, 2019 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the year and the quarter ended December 31, 2018 (Press release, Teva, FEB 13, 2019, View Source [SID1234533269]).

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Mr. Kåre Schultz, Teva’s President and CEO, said, "2018 was the first year of our restructuring plan and we have met or exceeded all of our key financial targets for the year. The full year yielded a cost base reduction of $2.2 billion, exceeding our 2018 target, and we are well on track to deliver the total $3.0 billion reduction in 2019 as compared to the 2017 spend base. AJOVY is performing very well since its September launch in the U.S. with growing demand for the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults. We will focus our investments on growing AJOVY and continuing our success with AUSTEDO, with both franchises positioned to be important growth drivers for Teva.

"Looking ahead, we continue to expect that 2019 will be the trough for our business, a year in which we will experience similar challenges to those of 2018 including the continued erosion of COPAXONE in the U.S. and Europe as well as the introduction of generics in the ProAir market. Throughout the year, we will continue to execute against our restructuring plan goals, including the optimization of our global portfolio and network, as we focus our efforts on generating cash to reduce the company’s debt."

2018 Annual Consolidated Results

Revenues in 2018 were $18,854 million, a decrease of 16% in both U.S. dollar and local currency terms, compared to 2017, mainly due to generic competition to COPAXONE, a decline in revenues in our U.S. generics business and loss of revenues following the divestment of certain products and discontinuation of certain activities.

Exchange rate movements between 2018 and 2017 positively impacted our revenues by $152 million, our GAAP operating income by $4 million and our non-GAAP operating income by $10 million.

GAAP gross profit was $8,296 million in 2018, a decrease of 22% compared to 2017. GAAP gross profit margin for 2018 was 44.0%, compared to 47.4% in 2017. Non-GAAP gross profit was $9,546 million in 2018, a decrease of 21% compared to 2017. Non-GAAP gross profit margin was 50.6% in 2018, compared to 53.8% in 2017. The decrease in both GAAP and non-GAAP gross profit was mainly due to lower profitability in North America resulting from a decline in COPAXONE revenues due to generic competition and a decline in revenues in our U.S. generics business, partially offset by higher profitability in Europe.

Research and Development (R&D) expenses in 2018 were $1,213 million, a decrease of 32% compared to 2017. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in 2018 were $1,102 million, or 5.8% of revenues, compared to $1,515 million or 6.8% in 2017. The decrease in R&D expenses resulted primarily from pipeline optimization, phase 3 studies that have ended and related headcount reductions.

Selling and Marketing (S&M) expenses in 2018 were $2,916 million, a decrease of 14% compared to 2017. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $2,718 million, or 14.4% of revenues, in 2018, compared to $3,149 million, or 14.1% of revenues, in 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

General and Administrative (G&A) expenses in 2018 were $1,298 million, a decrease of 11% compared to 2017. G&A expenses excluding equity compensation expenses were $1,228 million in 2018, or 6.5% of revenues, compared to $1,413 million or 6.3% of revenues in 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

GAAP other income in 2018 was $291 million, compared to other income of $1,199 million in 2017. The decline in GAAP other income was primarily the result of none recurring income related to the divestment of our women’s health business in 2017. Non-GAAP other income in 2018 was $225 million, an increase of 94% compared to $116 million in 2017, mainly due to higher Section 8 recoveries from multiple cases in Canada and recovery of lost profits in cases in which U.S. patent infringement litigation had previously prevented the sale of certain products.

GAAP Operating loss was $1,637 million in 2018 compared to operating loss of $17,484 million in 2017. The increase was mainly due higher goodwill impairment charges, higher intangible assets impairments and other asset impairments recorded in 2017. Non-GAAP operating income was $4,723 million, a decrease of 22% compared to $6,073 million in 2017.

Adjusted EBITDA (non-GAAP operating income, which excludes amortization and certain other items, and excluding depreciation expenses) in 2018 was $5,319 million, compared to $6,665 million in 2017.

In 2018, GAAP financial expenses were $959 million, compared to $895 million in 2017. Non-GAAP financial expenses were $893 in 2018, compared to $908 in 2017.

In 2018 we recognized a GAAP tax benefit of $195 million, or 8%, on pre-tax loss of $2,596 million. In 2017 we recognized a tax benefit of $1,933 million, or 11%, on pre-tax loss of $18,379 million. Our tax rate for 2018 was mainly affected by one-time legal settlements and divestments that had a low corresponding tax effect. Additionally, in 2018 we recorded impairments, some of which did not have a corresponding tax effect.

The non-GAAP income taxes for 2018 were $519 million on non-GAAP pre-tax income of $3,830 million. The non-GAAP income taxes in 2017 were $788 million on non-GAAP pre-tax income of $5,165 million. The non-GAAP tax rate for 2018 was 14%, compared to 15% in 2017. The decrease in our tax rate was mainly due to the reduction in the U.S. federal corporate tax rate following the U.S. tax reform.

GAAP net loss attributable to Teva’s ordinary shareholders and GAAP diluted loss per share in 2018 were $2,399 million and $2.35, respectively, compared to net loss of $16,525 million and diluted loss per share of $16.26 in 2017. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS in 2018 were $2,985 million and $2.92, respectively, compared to $4,075 million and $4.01 in 2017.

The weighted average diluted shares outstanding used for the fully diluted share calculation on a GAAP basis for 2018 and 2017 were 1,021 and 1,016 million shares, respectively. The weighted average outstanding shares used for the fully diluted EPS calculation on a non-GAAP basis for 2018 and 2017 were 1,024 and 1,018 million shares, respectively.

As of December 31, 2018 and 2017, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,100 million and 1,086 million shares, respectively.

Non-GAAP information: Net non-GAAP adjustments in 2018 were $5,384 million. Non-GAAP net income and non-GAAP EPS for the year were adjusted to exclude the following items:

A goodwill impairment of $3,027 million, mainly related to International Markets;
An impairment of intangible and fixed assets and equity investment of $2,594 million mainly related to the acquisition of Actavis Generics;
Amortization of purchased intangible assets totaling $1,166 million, of which $1,004 million is included in cost of goods sold and the remaining $162 million in selling and marketing expenses;
Restructuring expenses of $488 million;
Equity compensation expenses of $152 million;
In-Process R&D of $83 million;
Financial expenses of $66 million mainly related to early redemption fees;
Contingent consideration of $57 million;
Other non-GAAP items of $104 million;
Minority interest adjustment of $431 million mainly relate to business venture in International markets;
Related tax effect of $714 million; and
Benefits from legal settlements and loss contingencies of $1,208 million, mainly related to the Allergan working capital adjustments, the Rimsa settlement and the reversal of the reserve recorded for the carvedilol judgement against Teva.
Teva believes that excluding such items facilitates investors’ understanding of its business. For further information see the below tables for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and the information under "Non-GAAP Financial Measures." 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 operating activities in 2018 was $2,446 million, an increase of $221 million, or 10% compared to 2017. This increase was mainly due to the working capital adjustment with Allergan and the Rimsa settlement in 2018, partially offset by lower profit in our North America segment.

Free cash flow (Cash flow generated from operating activities in 2018, net of cash used for capital investments and beneficial interest collected in exchange for securitized trade receivables) was $3,679 million, compared to $2,693 million in 2017. This increase resulted mainly from the higher cash flow generated from operating activities, higher beneficial interest collected in exchange for securitized trade receivables and lower capital expenditures.

As of December 31, 2018, our debt was $28,916 million, compared to $32,475 million as of December 31, 2017. The decrease was mainly due to senior notes and term loans repaid at maturity or prepaid with cash generated during the year. The portion of total debt classified as short-term as of December 31, 2018 was 8%, compared to 11% as of December 31, 2017, due to a decrease in current maturities. Our average debt maturity was approximately 6.8 years as of December 31, 2018, compared to 6.4 years as of December 31, 2017.

Annual Report on Form 10-K

Teva will file its Annual Report on Form 10-K with the SEC in the coming days. The report will include a complete analysis of the financial results for 2018 and will be available on Teva’s website, View Source, as well as on the SEC’s website: View Source

Fourth Quarter 2018 Consolidated Results

Revenues in the fourth quarter of 2018 were $4,559 million, a decrease of 16%, or 14% in local currency terms, compared to the fourth quarter of 2017, mainly due to generic competition to COPAXONE, a decline in revenues in our U.S. generics business and loss of revenues following the divestment of certain products and discontinuation of certain activities.

Exchange rate differences between the fourth quarter of 2018 and the fourth quarter of 2017 negatively impacted our revenues and GAAP operating income by $100 million and $13 million, respectively. Our non-GAAP operating income was negatively impacted by $17 million.

GAAP gross profit was $1,971 million in the fourth quarter of 2018, a decrease of 19% compared to the fourth quarter of 2017. GAAP gross profit margin was 43.2% in the fourth quarter of 2018, compared to 45.3% in the fourth quarter of 2017. Non-GAAP gross profit was $2,328 million in the fourth quarter of 2018, a decline of 15% from the fourth quarter of 2017. Non-GAAP gross profit margin was 51.1% in the fourth quarter of 2018, compared to 50.9% in the fourth quarter of 2017. The increase in gross profit margin on a non-GAAP basis resulted primarily from improved gross profit margin in our Europe segment.

Research and Development (R&D) expenses for the fourth quarter of 2018 were $295 million, a decrease of 15% compared to the fourth quarter of 2017. R&D expenses excluding equity compensation expenses and other expenses were $289 million, or 6.3% of quarterly revenues in the fourth quarter of 2018, compared to $295 million, or 5.5% of quarterly revenues in the fourth quarter of 2017. The decrease in R&D expenses resulted primarily from pipeline optimization, phase 3 studies that have ended and related headcount reduction.

Selling and Marketing (S&M) expenses in the fourth quarter of 2018 were $797 million, a decrease of 3% compared to the fourth quarter of 2017. S&M expenses excluding amortization of purchased intangible assets, equity compensation expenses and other expenses were $768 million, or 16.8% of quarterly revenues in the fourth quarter of 2018, compared to $749 million, or 13.9% of quarterly revenues in the fourth quarter of 2017. The increase was mainly due to higher promotional cost associated with the launch of AJOVY in the U.S., partially offset by cost reduction and efficiency measures as part of the restructuring plan.

General and Administrative (G&A) expenses in the fourth quarter of 2018 were $344 million, a decrease of 2% compared to the fourth quarter of 2017. G&A expenses excluding equity compensation expenses and other expenses were $330 million in the fourth quarter of 2018, or 7.2% of quarterly revenues in the fourth quarter of 2018, compared to $335 million, or 6.2% of quarterly revenues in the fourth quarter of 2017.

GAAP other loss in the fourth quarter of 2018 was $43 million, compared to other income of $1,099 million in the fourth quarter of 2017. Non-GAAP other income in the fourth quarter of 2018 was $5 million, compared to $15 million in fourth quarter of 2017.

GAAP operating loss in the fourth quarter of 2018 was $3,164 million, compared to $13,017 million in the fourth quarter of 2017. Non-GAAP operating income in the fourth quarter of 2018 was $946 million, a decrease of 32% compared to the fourth quarter of 2017. Non-GAAP operating margin was 20.8% in the fourth quarter of 2018 compared to 25.7% in the fourth quarter of 2017.

EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as depreciation expenses) was $1,091 million in the fourth quarter of 2018, a decrease of 29% compared to $1,534 million in the fourth quarter of 2017.

GAAP financial expenses for the fourth quarter of 2018 were $223, compared to $191 million in the fourth quarter of 2017. Non-GAAP financial expenses were $216 million in the fourth quarter of 2018, compared to $209 million in the fourth quarter of 2017.

In the fourth quarter of 2018, we recognized a tax benefit of $139 million, or 4%, on pre-tax loss of $3,387 million. In the fourth quarter of 2017, we recognized a tax benefit of $1,471 million, on pre-tax loss of $13,208 million. Our tax rate for the fourth quarter of 2018 was mainly affected by impairments recorded, some of which did not have a corresponding tax effect. Non-GAAP income taxes for the fourth quarter of 2018 were $96 million, or 13%, on pre-tax non-GAAP income of $730 million. Non-GAAP income taxes in the fourth quarter of 2017 were $183 million, or 16%, on pre-tax non-GAAP income of $1,176 million.

GAAP net loss attributable to ordinary shareholders and GAAP diluted loss per share in the fourth quarter of 2018 were $2,940 million and $2.85, respectively, compared to loss of $11,600 million and $11.41 in the fourth quarter of 2017. Non-GAAP net income attributable to ordinary shareholders and non-GAAP diluted EPS in the fourth quarter of 2018 were $543 million and $0.53, respectively, compared to $949 million and $0.93 in the fourth quarter of 2017.

For the fourth quarter of 2018, the weighted average outstanding shares for the fully diluted EPS calculation on a GAAP basis was 1,031 million shares, compared to 1,017 million shares in the fourth quarter of 2017. The weighted average outstanding shares for the fully diluted EPS calculation on a non-GAAP basis was 1,034 million shares, compared to 1,018 million shares in the fourth quarter of 2017.

Non-GAAP information: Net non-GAAP adjustments in the fourth quarter of 2018 were $3,483 million. Non-GAAP net income and non-GAAP EPS for the fourth quarter were adjusted to exclude the following items:

A goodwill impairment of $2,727 million, mainly related to International Markets;
An impairment of intangible and fixed assets and equity investment of $990 million mainly related to the acquisition of Actavis Generics;
Amortization of purchased intangible assets totaling $257 million, of which $233 million is included in cost of goods sold and the remaining $24 million in selling and marketing expenses;
Restructuring expenses of $46 million;
Legal settlements and loss contingencies of $31 million;
Equity compensation expenses of $30 million;
Other non-GAAP items of $36 million;
Minority interest adjustment of $399 million related to business venture in the International markets; and
Related tax effect of $235 million.
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 fourth quarter of 2018 was $367 million, compared to $859 million in the fourth quarter of 2017. The decrease was mainly due to lower profit in our North America segment.

Free cash flow (Cash flow generated from operating activities, net of cash used for capital investments and beneficial interest collected in exchange for securitized trade receivables) was $522 million in the fourth quarter of 2018, compared to $934 million in the fourth quarter of 2017. The increase in 2018 resulted mainly from the higher cash flow generated from operating activities.

Segment Results for the Fourth Quarter 2018

Due to the organizational changes announced in November 2017, we began reporting our financial results under a new structure in the first quarter of 2018, consisting of the following segments:

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) International 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 the sale of API to third parties 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.

The data presented in this press release for prior periods have been conformed to reflect our current segment reporting, which commenced in the first quarter of 2018.

North America Segment

Our North America segment includes the United States and Canada.

Revenues from our North America segment in the fourth quarter of 2018 were $2,238 million, a decrease of $451 million, or 17%, compared to the fourth quarter of 2017, mainly due to a decline in revenues of COPAXONE, our U.S. generics business, ProAir and QVAR and the loss of revenues from the sale of our women’s health business, partially offset by higher revenues from AUSTEDO and Anda.

Revenues in the United States, our largest market, were $2,103 million in the fourth quarter of 2018, a decrease of $434 million, or 17%, compared to the fourth quarter of 2017.

Revenues by Major Products and Activities

Generic products revenues in our North America segment in the fourth quarter of 2018 decreased by 10% to $1,099 million, compared to the fourth quarter of 2017, mainly due to additional competition to methylphenidate extended-release tablets (Concerta authorized generic), portfolio optimization primarily as part of the restructuring plan as well as market dynamics and price erosion in our U.S. generics business, partially offset by new generic product launches.

In the fourth quarter of 2018, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 504 million total prescriptions (based on trailing twelve months), representing 13% of total U.S. generic prescriptions according to IQVIA data.

COPAXONE revenues in our North America segment in the fourth quarter of 2018 decreased by 44% to $356 million, of which $341 million were generated in the United States, compared to the fourth quarter of 2017, mainly due to generic competition in the United States.

BENDEKA and TREANDA combined revenues in our North America segment in the fourth quarter of 2018 decreased by 11% to $140 million, compared to the fourth quarter of 2017, mainly due to lower volumes resulting from Eagle Pharmaceuticals’ launch of a ready-to-dilute bendamustine hydrochloride in June 2018, partially offset by higher pricing.

ProAir revenues in our North America segment in the fourth quarter of 2018 decreased by 56% to $45 million, compared to the fourth quarter of 2017, mainly due to higher sales reserves recorded in the fourth quarter of 2018 in anticipation of generic competition to the short-acting beta-agonist class of drugs, including an approved generic version of Ventolin HFA. In the albuterol inhaler category, approximately 40% of prescriptions are written as "generic albuterol," which means that the launch of any generic inhaler may cause patient migration to such generic products. We launched our own ProAir authorized generic in the United States in January 2019.

QVAR revenues in our North America segment in the fourth quarter of 2018 decreased by 81% to $9 million, compared to the fourth quarter of 2017. The decrease in sales was mainly due to lower net pricing.

AUSTEDO revenues in our North America segment in the fourth quarter of 2018 were $68 million, compared to $17 million in the fourth quarter of 2017.

Anda revenues in our North America segment in the fourth quarter of 2018 increased by 26% to $363 million, compared to the fourth quarter of 2017.

North America Gross Profit

Gross profit from our North America segment in the fourth quarter of 2018 was $1,201 million, a decrease of 20% compared to $1,506 million in the fourth 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 fourth quarter of 2018 decreased to 53.7%, compared to 56.0% in the fourth quarter of 2017. This decrease was mainly due to lower COPAXONE revenues.

North America Profit

Profit from our North America segment in the fourth quarter of 2018 was $551 million, a decrease of 41% compared to $938 million in the fourth quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products as well as investment in the launch of AJOVY.

Europe Segment

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

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

Revenues from our Europe segment in the fourth quarter of 2018 were $1,204 million, a decrease of $246 million, or 17%, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 14%, mainly due to the loss of revenues from the closure of our distribution business in Hungary, the sale of our women’s health business and a decline in COPAXONE revenues, partially offset by new generic product launches.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended December 31, 2018 and 2017:

Generic products revenues in our Europe segment in the fourth quarter of 2018, including OTC products, decreased by 9% to $844 million, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 6%, mainly due to the loss of revenues from the termination of the PGT joint venture and generic price reductions, partially offset by new generic product launches.

COPAXONE revenues in our Europe segment in the fourth quarter of 2018 decreased by 24% to $118 million, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 21%, mainly due to price reductions resulting from the entry of competing glatiramer acetate products.

Respiratory products revenues in our Europe segment in the fourth quarter of 2018 decreased by 18% to $90 million, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 15%, mainly due to lower sales in the United Kingdom.

Europe Gross Profit

Gross profit from our Europe segment in the fourth quarter of 2018 was $689 million, a decrease of 9% compared to $758 million in the fourth quarter of 2017. The decrease was mainly due to the loss of revenues from the sale of our women’s health business and a decline in COPAXONE revenues. Gross profit margin for our Europe segment in the fourth quarter of 2018 increased to 57.2%, compared to 52.3% in the fourth quarter of 2017. This increase was mainly due to lower cost of goods sold, primarily as a result of the termination of the PGT joint venture and the closure of our distribution business in Hungary.

Europe Profit

Profit from our Europe segment in the fourth quarter of 2018 was $253 million, a decrease of 16% compared to $301 million in the fourth quarter of 2017. The decrease was mainly due to lower revenues, partially offset by cost reductions and efficiency measures as part of the restructuring plan.

International Markets Segment

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

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 the fourth quarter of 2018.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended December 31, 2018 and 2017:

Revenues from our International Markets segment in the fourth quarter of 2018 were $740 million, a decrease of $170 million, or 19%, compared to the fourth quarter of 2017. In local currency terms, revenues decreased 13% compared to the fourth quarter of 2017, mainly due to lower sales in Russia and Japan, 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

The following table presents revenues for our International Markets segment by major products and activities for the three months ended December 31, 2018 and 2017:

Generic products revenues in our International Markets segment in the fourth quarter of 2018, which include OTC products, decreased by 23% to $499 million, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 18%, mainly due to lower sales in Russia and lower sales in Japan resulting from regulatory pricing reductions and generic competition to off-patented products.

COPAXONE revenues in our International Markets segment in the fourth quarter of 2018 decreased by 23% to $20 million, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 6%.

Distribution revenues in our International Markets segment in the fourth quarter of 2018 increased by 1% to $146 million, compared to the fourth quarter of 2017. In local currency terms, revenues increased by 6%.

International Markets Gross Profit

Gross profit from our International Markets segment in the fourth quarter of 2018 was $312 million, a decrease of 20% compared to $390 million in the fourth quarter of 2017. Gross profit margin for our International Markets segment in the fourth quarter of 2018 decreased to 42.1%, compared to 42.9% in the fourth quarter of 2017. The decrease was mainly due to lower gross profit resulting from changes in the product mix in certain countries, mainly Russia and Japan.

International Markets Profit

Profit from our International Markets segment in the fourth quarter of 2018 was $114 million, compared to $155 million in the fourth quarter of 2017. The decrease was mainly due to lower revenues in Russia and Japan, partially offset by cost reductions and efficiency measures as part of the restructuring plan.

Other Activities

We have other sources of revenues, primarily the sale of API to third parties and certain contract manufacturing services. These other activities are not included in our North America, Europe or International Markets segments.

Our revenues from other activities in the fourth quarter of 2018 increased by 8% to $377 million, compared to the fourth quarter of 2017. In local currency terms, revenues increased by 9%.

API sales to third parties in the fourth quarter of 2018 were $209 million, an increase of 16% compared to the fourth quarter of 2017. In local currency terms, revenues increased by 16%.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, February 13, 2019 at 8:00 a.m. ET to discuss its fourth quarter and annual 2018 results and overall business environment. A question & answer session will follow.

passcode: 1174907

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

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website by calling United States 1-866-331-1332; International +44 (0) 3333 009785; passcode: 1174907.

NanOlogy to Present Positive Preclinical Data for NanoDoce® in Treatment of Uro-Oncologic Cancers at 2019 Genitourinary Cancers (ASCO-GU) Symposium

On February 13, 2019 NanOlogy, a clinical-stage oncology company, reported that it will present an abstract at the 2019 Genitourinary Cancer Symposium, co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held February 14-16, 2019 in the Moscone West Building, San Francisco (Press release, NanOlogy, FEB 13, 2019, View Source [SID1234533287]).

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Data from preclinical studies of NanoDoce (submicron particle docetaxel suspension) administered via intratumoral injection will be presented showing prolonged, high concentration of drug at the tumor site and significant tumor regression in multiple xenograft animal models including clear cell renal carcinoma (768-O cell line), transitional cell bladder carcinoma (UM-UC-3 cell line), and prostate carcinoma (PC-3 cell line). Abstract title, location, and times follow:

Title: Evaluation of submicron particle docetaxel directly injected into uro-oncologic xenografts
Poster Session: B – Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers
Where: Board E17 Abstract #360, West Building Moscone, San Francisco
When: Friday, February 15, 2019, 12:15 to 1:45 PM and 5:15 to 6:15 PM
Data from the preclinical studies showed that tumor volume decreases with two and three intratumoral doses of NanoDoce were significantly greater than or similar to IV docetaxel. Immunohistochemistry evaluations for the renal and bladder cancer models revealed immune cell infiltration in NanoDoce-treated animals. Drug was detected in NanoDoce-treated tumor tissue up to 50 days after administration, and at levels far greater than IV-treated animals.

Persistent, therapeutic levels of docetaxel from intratumoral NanoDoce appear to kill tumor cells through direct and indirect means. NanoDoce is known to directly inhibit tumor cell mitosis, and its persistence results in prolonged release of tumor antigen, which appears to promote indirect immune cell-mediated tumor kill.

A clinical trial in high-risk non-muscle invasive (NMIBC) and muscle invasive bladder cancer (MIBC) will begin enrollment in the first quarter of this year. Following transurethral resection of bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with intravesical instillations of NanoDoce.

In addition, IND-enabling studies are nearing completion on NanoDoce for renal cell carcinoma to allow for a clinical trial via intratumoral injection in the second half of 2019. This work is part of an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, breast cancer, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036 in the US, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

Inovio Pharmaceuticals Announces Proposed Convertible Senior Notes Offering

On February 13, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported its intention to offer, subject to market and other conditions, $65 million aggregate principal amount of convertible senior notes due 2024 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Inovio, FEB 13, 2019, View Source [SID1234533305]). Inovio also expects to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $20 million aggregate principal amount of notes.

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The notes will be senior unsecured Inovio obligations and will accrue interest payable semiannually in arrears. The notes will be convertible in certain circumstances into cash, shares of Inovio’s common stock, or a combination of cash and shares of Inovio’s common stock, at Inovio’s election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of the pricing of the offering.

Inovio anticipates using the net proceeds from this offering for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses and manufacturing expenses, and for other business development activities.

The offer and sale of the notes and the shares, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or applicable state securities laws, and the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes or any shares issuable upon conversion of the notes, nor shall there be any sale of the notes or such shares, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.

ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-402 (loncastuximab tesirine) and IMFINZI® (durvalumab) in Multiple Types of Advanced Non-Hodgkin Lymphoma

On February 13, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) plus AstraZeneca’s IMFINZI (durvalumab) in patients with advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) (Press release, ADC Therapeutics, FEB 13, 2019, View Source [SID1234596065]).

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ADCT-402, an ADC designed to target and kill CD19-expressing malignant B-cells, is also being evaluated in an ongoing pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) DLBCL. Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "Data from our 183-patient first-in-human clinical trial of ADCT-402, which were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated its acceptable safety profile and promising anti-tumor activity as a single agent in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. We are now excited to explore the possible impact of ADCT-402 plus durvalumab in patient populations that would greatly benefit from new treatment options."

Craig Moskowitz, MD, Physician in Chief for the Cancer Service Line of the Sylvester Comprehensive Cancer Center, Professor of Medicine in the Miller School of Medicine at University of Miami Health System, and an investigator for the trial, said, "While the majority of patients with non-Hodgkin lymphoma typically respond to initial treatment, many patients relapse and face a poor prognosis. I look forward to evaluating this combination therapy of ADCT-402 and a PD-L1 blocker to determine its safety and potential anti-tumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma who have failed or are intolerant to established therapies, or who don’t have other available treatment options."

The open-label, single-arm trial will include a dose-escalation part, followed by a dose-expansion part. The dose-expansion part will consist of up to three expansion cohorts – one for DLBCL, one for MCL and one for FL – to obtain additional safety and preliminary anti-tumor activity information at the maximum tolerated dose. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03685344).

ADCT-402 Interim First-in-Human Data

Updated data from the ongoing 183-patient Phase I clinical trial of ADCT-402 were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In a subpopulation of 139 evaluable patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had failed or were intolerant to established therapies, ADCT-402 demonstrated manageable toxicity. At doses >120 μg/kg, the overall response rate (ORR) was 43.3 percent (55/127 patients with DLBCL), comprising 23.6 percent complete responses and 19.7 percent partial responses. In a subgroup of 15 patients with R/R mantle cell lymphoma (MCL) and 14 patients with R/R follicular lymphoma (FL), ADCT-402 demonstrated manageable toxicity. In MCL patients, ORR was 46.7 percent (7/15) and median duration of response (DoR) was not reached after a median follow-up time of 8.7 months. In FL patients, ORR was 78.6 percent (11/14) and median DoR was not reached after a median follow-up time of 11.6 months.

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469) and a Phase I clinical trial in combination with IMFINZI (durvalumab) in patients with R/R DLBCL, mantle cell lymphoma or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and MCL.

Arcus Biosciences Announces Participation at Upcoming Investor Conference

On February 13, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that Terry Rosen, Ph.D., Chief Executive Officer, will participate in a fireside chat at the 8th Annual Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 at 11:30 am ET at the Lotte New York Palace, in New York, NY (Press release, Arcus Biosciences, FEB 13, 2019, View Source [SID1234533288]).

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To access the live audio webcast of the presentation, please visit the "Events & Presentations" section of the Arcus website at View Source A replay of the webcast will be available for 30 days following the live event.