On November 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter of 2019 and provided a corporate update (Press release, Arvinas, NOV 4, 2019, View Source [SID1234550226]).

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"We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs. In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our PROTAC platform," said John Houston, Ph.D., Chief Executive Officer of Arvinas. "We look forward to the continued progress of our lead programs and pipeline, and ultimately to making a difference in the lives of patients."

Business Highlights and Recent Developments

Presented initial data from the company’s ongoing Phase 1 clinical trials of ARV-110 and ARV-471. The initial data showed dose proportionality for ARV-110 and that exposures of both ARV-110 and ARV-471 have reached levels associated with tumor growth inhibition in preclinical studies. In addition, both ARV-110 and ARV-471, at each dose tested to date, were well tolerated, with no dose-limiting toxicities and no observed grade 2, 3, or 4 adverse events related to treatment.
Presented preclinical data from the company’s alpha-synuclein (a-synuclein)-targeted PROTAC protein degrader program. The data showed that the company has created a-synuclein-targeted degraders that degrade oligomeric a-synuclein. In addition, the company has created a-synuclein-targeting PROTAC protein degraders that cross the blood-brain barrier following parenteral (peripheral) administration.
Announced that six new oncology and neurology thought leaders in the areas of oncology and neurological disorders have joined the company’s scientific advisory board (SAB). The new members are Tomasz M. Beer, M.D., F.A.C.P., Adam L. Boxer, M.D., Ph.D., Sara Courtneidge, Ph.D., Lennart Mucke, M.D., Benjamin G. Neel, M.D., Ph.D., and Lillian L. Siu, M.D. For full details on our new SAB members, visit www.arvinas.com.
Initiated patient dosing in its ongoing Phase 1 clinical trial of ARV-471, which is evaluating the safety, tolerability, and pharmacokinetics of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer.
Anticipated Milestones and Expectations

For the ARV-110 program, Arvinas expects to next share completed Phase 1 dose escalation clinical data in the first half of 2020.
For the ARV-471 program, Arvinas expects to next share clinical data in the second half of 2020.
Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the second half of 2021.

Financial Highlights

Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2019, cash, cash equivalents, and marketable securities were $190.5 million as compared to $187.8 million as of December 31, 2018. The increase in cash, cash equivalents and marketable securities of $2.7 million in the first nine months of 2019 primarily related to aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer, partially offset by the purchase of lab equipment and leasehold improvements of $4.5 million and cash used to fund operations of $49.7 million.

Research and Development Expenses: Research and development expenses were $16.6 million for the quarter ended September 30, 2019, as compared to $13.1 million for the quarter ended September 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with our ongoing Phase 1 clinical trial of ARV-110 and the initiation of our Phase 1 clinical trial of ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory programs research.

General and Administrative Expenses: General and administrative expenses were $8.0 million for the quarter ended September 30, 2019, as compared to $4.3 million for the quarter ended September 30, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming a public company in the fourth quarter of 2018.

Revenues: Revenue was $30.1 million for the quarter ended September 30, 2019, as compared to $3.4 million for the quarter ended September 30, 2018. Revenue for the quarter ended September 30, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC technology in agricultural applications (the "Joint Venture"). The remaining revenue of $5.4 million for the quarter was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.

Loss from Equity Method Investment: Loss from equity method investment for the quarter ended September 30, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture’s expensing the values associated with the contributed intellectual property from the Joint Venture partners.

Net Loss: Net loss was $17.7 million for the quarter ended September 30, 2019, as compared to $13.4 million for the quarter ended September 30, 2018. The increased revenue that related to the Joint Venture was offset by the loss from equity method investment in the Joint Venture for the quarter ended September 30, 2019 and as such, the increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.

About ARV-110
ARV-110 is an orally-bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas’ Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471
ARV-471 is a PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic breast cancer. Arvinas’ Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity as a single agent and in combination with a CDK4/6 inhibitor when compared to a standard of care agent, fulvestrant (as a single agent and in combination with a CDK4/6 inhibitor).

On November 4, 2019 Agilent Technologies Inc. (NYSE: A) reported that it will release fourth quarter fiscal year 2019 financial results after the stock market closes on November 25 (Press release, Agilent, NOV 4, 2019, https://www.agilent.com/about/newsroom/presrel/2019/04nov-gp19023.html [SID1234550225]). The company will also host a live webcast of its investor conference call in listen-only mode.

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Date: Monday, November 25, 2019
Time: 1:30 PM (Pacific Time)
Web access: www.investor.agilent.com

To listen to the call online, select the "Q4 2019 Agilent Technologies Inc. Earnings Conference Call" link in the "News & Events — Events" portion of the Investor Relations section of the Agilent website. The webcast will remain on the company site for 90 days.

In addition, Agilent will be hosting the following upcoming webcasts for the investment community.

Piper Jaffray 31st Annual Healthcare Conference
Wednesday, December 4, at 8:30 a.m. (ET)
Lotte New York Palace, New York
Bob McMahon, Agilent chief financial officer

Evercore ISI 2nd Annual HealthCONx
Thursday, December 5, at 8:00 a.m. (ET)
Four Seasons Boston, Boston, Mass.
Bob McMahon, Agilent chief financial officer

Links to join the webcasts will be available in the "News & Events — Events" portion of the Investor Relations section of the Agilent website.

On November 4, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided a financial update for the quarter ended September 30, 2019 (Press release, Acorda Therapeutics, NOV 4, 2019, View Source [SID1234550224]).

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"Our focus has been on ensuring physician awareness and clearing a pathway for access to Inbrija. We have been receiving encouraging feedback on Inbrija from physicians suggesting it should become standard of care for the treatment of Parkinson’s. This is consistent with market research from healthcare professionals and people living with Parkinson’s indicating that Inbrija will become a significant product," said Ron Cohen, M.D., Acorda’s President and CEO. "Acorda’s recent restructuring, albeit difficult, substantially reduced our expense structure, so that we may more effectively focus our resources on the launch of Inbrija and the restructuring of our convertible debt."

Third Quarter 2019 Financial Results

For the quarter ended September 30, 2019, the Company reported INBRIJA net revenue of $4.9 million. INBRIJA became commercially available on February 28, 2019.

For the quarter ended September 30, 2019, the Company reported AMPYRA net revenue of $37.6 million compared to $137.8 million for the same quarter in 2018. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended September 30, 2019 were $16.1 million, including $0.7 million of share-based compensation compared to $22.9 million, including $1.1 million of share-based compensation for the same quarter in 2018.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2019 were $48.7 million, including $2.4 million of share-based compensation compared to $43.6 million, including $4.0 million of share-based compensation for the same quarter in 2018.

The Company reviewed its goodwill for the quarter ended September 30, 2019 as part of its normal reporting process. The Company determined that a triggering event occurred due to a decline in the trading price of the Company’s common stock at and around the end of the quarter ended September 30, 2019. Based on the analysis performed, the Company determined that the goodwill was fully impaired and recorded a non-cash impairment charge of $277.6 million.

Provision for income taxes for the quarter ended September 30, 2019 was $0.02 million compared to a provision for income taxes of $38.0 million for the same quarter in 2018.

The Company reported a GAAP net loss of $263.5 million for the quarter ended September 30, 2019, or $5.55 per diluted share. GAAP net loss in the same quarter of 2018 was $13.9 million, or $0.29 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2019 was $21.9 million, or $0.46 per diluted share. Non-GAAP net income in the same quarter of 2018 was $8.1 million, or $0.17 per diluted share. This quarterly non-GAAP net (loss) income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and goodwill impairment charges. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2019, the Company had cash, cash equivalents and short-term investments of $253 million. The Company has $345 million of convertible senior notes due in 2021 with a conversion price of $42.56.

Revised 2019 Financial Guidance; 2020 Financial Guidance

2019: R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million.
2020: R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A expenses for the full year 2020 are expected to be $160 – $165 million.
These are non-GAAP projections that exclude restructuring costs and share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
Highlights

Corporate Restructuring
– In October, the Company announced a corporate restructuring to reduce costs and focus its resources on the launch of INBRIJA. As part of this restructuring, Acorda is reducing headcount by approximately 25% through a reduction in force which is expected to be completed in Q1 2020. In connection with the restructuring, the Company also announced the reduced estimated 2019 operating expenses and 2020 operating expense guidance described above.

– The Company expects to realize estimated annualized cost savings related to headcount reduction of approximately $21 million beginning in 2020. Acorda estimates that it will incur approximately $8 million of pre-tax charges for severance and other costs related to the restructuring, through the first quarter of 2020.

– Total operating expenses in 2020 are estimated to be ~$60 million less than in 2019.

INBRIJA launch metrics through October 2019
– ~ 6,400 prescription request forms (PRFs)

– > 3,100 patients received a first dispense

– > 12,750 total cartons dispensed

– > 1,600 unique prescribers; ~55% repeat prescribers

As of October 30, 2019, INBRIJA is available in the U.S. without the need for a medical exception for ~66% of commercial and ~25% of Medicare plan lives.
On September 24, the European Commission (EC) granted Marketing Authorization for Inbrija 33 mg inhalation powder, hard capsules. The Marketing Authorization approves Inbrija for use in the 28 countries of the European Union, as well as Iceland, Norway and Liechtenstein.
On October 7, the U. S. Supreme Court denied the Company’s petition for certiorari requesting review of the Federal Circuit Court of Appeals’ decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, et al. That decision upheld the invalidation of certain Ampyra patents in litigation against various generics manufacturers.
Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 5464078. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on November 4, 2019 until 11:59 p.m. ET on December 4, 2019. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 5464078. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net (loss) income, adjusted to exclude the items below, and has provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net (loss) income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization, and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) goodwill impairment which is a non-cash charge that relates to a reduction in the market capitalization of the Company and is not routine to the operation of the business, and (v) expenses that pertain to non-routine restructuring events. The Company believes its non-GAAP net (loss) income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net (loss) income, we have provided 2019 and 2020 guidance for R&D and SG&A expenses on a non-GAAP basis, as both exclude restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, The Company believes that the presentation of these non-GAAP measures, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our projected operating performance because they exclude (i) expenses that pertain to non-routine restructuring events, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On November 4, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its third-quarter 2019 financial results (Press release, Bausch Health, NOV 4, 2019, View Source [SID1234550217]).

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"In the third quarter, Bausch Health delivered another strong quarter with both reported and organic revenue growth1,2, demonstrating that our efforts to grow our core businesses are continuing to gain traction. In addition to organic revenue growth1,2 in both the Bausch + Lomb/International and Salix segments due to higher revenues in several of our durable, established brands, such as XIFAXAN, BioTrue ONEday and Bausch + Lomb ULTRA, our performance was also strengthened by the success of newer products, such as LUMIFY and Thermage FLX, " said Joseph C. Papa, chairman and CEO, Bausch Health. "Additionally, we are excited by the potential we see from the early days of the launch of DUOBRII, the newest product in our dermatology portfolio."

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 53% of the Company’s reported revenue in the third quarter of 2019

Increased reported revenue in the Bausch + Lomb/International segment by 2% compared to the third quarter of 2018; revenue in this segment grew organically1,2 by 5% compared to the third quarter of 2018; growth was primarily driven by the Global Consumer, International Rx and Global Vision Care business units

Delivered 12th consecutive quarter of organic revenue growth1,2
___________________________________
1 Please see the tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the nearest comparable GAAP measure.
2 Organic growth/change, a non-GAAP metric, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.

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Launched Ocuvite Eye Performance vitamins in the United States, which are formulated to help protect the eye from digital device blue light and UV exposure from the sun

The Salix segment comprised approximately 25% of the Company’s reported revenue in the third quarter of 2019

Increased reported revenue in the Salix segment by 20% compared to the third quarter of 2018

Increased reported revenue of XIFAXAN by 24% compared to the third quarter of 2018

The Ortho Dermatologics segment comprised approximately 7% of the Company’s reported revenue in the third quarter of 2019

The U.S. Food and Drug Administration accepted the New Drug Application for ARAZLO3 (IDP-123) Lotion with a PDUFA action date of Dec. 22, 2019; if approved, ARAZLO3 will be the first tazarotene acne treatment available in a lotion form

Expanded the cash-pay prescription program, Dermatology.com, to all Walgreens U.S. retail pharmacy locations

Reported revenues in the Global Solta business unit increased by 62% compared to the third quarter of 2018, driven by continued strong demand of Thermage FLX following the launch in the Asia Pacific region

Released annual Corporate Social Responsibility report

Strategic Capital Allocation and Debt Management

Increased Research and Development (R&D) by approximately 15%, or $16 million, compared to the third quarter of 2018

Repaid debt by approximately $450 million in the third quarter of 2019, including the net impact of activity under our revolving credit facility

Third-Quarter 2019 Revenue Performance
Total reported revenues were $2.209 billion for the third quarter of 2019, as compared to $2.136 billion in the third quarter of 2018, an increase of $73 million, or 3%. Excluding the unfavorable impact of foreign exchange of $15 million, the impact of a 2019 acquisition of $14 million and the impact of divestitures and discontinuations of $13 million, revenue grew organically1,2 by 4% compared to the third quarter of 2018, driven by organic growth2 in the Salix and Bausch + Lomb/International segments.

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.175 billion for the third quarter of 2019, as compared to $1.147 billion for the third quarter of 2018, an increase of $28 million, or 2%. Excluding the unfavorable impact of foreign exchange of $15 million and the impact of divestitures and discontinuations of $9 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 5% compared to the third quarter of 2018. The increase was primarily driven by growth in the Global Consumer, International Rx and Global Vision Care business units.

Salix Segment
Salix segment revenues were $551 million for the third quarter of 2019, as compared to $460 million for the third quarter of 2018, an increase of $91 million, or 20%. The increase was primarily driven by XIFAXAN, which grew 24% as compared to the third quarter of 2018.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $147 million for the third quarter of 2019, as compared to $176 million for the third quarter of 2018, a decrease of $29 million, or 16%, due to lower volumes primarily driven by the loss of exclusivity of ZOVIRAX, SOLODYN and ELIDEL, partially offset by organic revenue growth2 in the Global Solta business unit and from new product launches in the Ortho Dermatologics business unit.

Diversified Products Segment
Diversified Products segment revenues were $336 million for the third quarter of 2019, as compared to $353 million for the third quarter of 2018, a decrease of $17 million, or 5%. The decrease was primarily attributable to the previously reported loss of exclusivity for a basket of products.

Operating Income
Operating income was $329 million for the third quarter of 2019, as compared to an operating income of $117 million for the third quarter of 2018, an increase of $212 million. The increase in operating results for the third quarter of 2019 was primarily driven by a decrease in amortization and impairments and the increase in reported revenues and higher gross margins in 2019 as compared to 2018, offset by increased Selling, general and administrative (SG&A) expenses and R&D expenses.

Net Loss
Net loss for the three months ended Sept. 30, 2019 was $49 million, as compared to net loss of $350 million for the same period in 2018, a favorable impact of $301 million. The change is primarily due to the increased operating results noted above and the favorable change in income tax provision.

Adjusted net income (non-GAAP)1 for the third quarter of 2019 was $425 million, as compared to $403 million for the third quarter of 2018, an increase of $22 million, or 5%.

Cash Generated from Operations
The Company generated $515 million of cash from operations in the third quarter of 2019, as compared to $522 million in the third quarter of 2018.

EPS
GAAP Earnings Per Share (EPS) Diluted for the third quarter of 2019 was ($0.14), as compared to ($1.00) for the third quarter of 2018.

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Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $942 million for the third quarter of 2019, as compared to $916 million for the third quarter of 2018, an increase of $26 million, or 3%.

2019 Financial Outlook
Bausch Health raised its revenue and Adjusted EBITDA (non-GAAP) guidance ranges for the full year of 2019:

Raised full-year revenue range from $8.40 – $8.60 billion to $8.475 – $8.625 billion

Raised full-year Adjusted EBITDA (non-GAAP) range from $3.425 – $3.575 billion to $3.50 – $3.60 billion

Mid-point of the November guidance ranges is up by $50 million versus the mid-point of the August 2019 guidance ranges

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release. The primary reasons for our change in our 2019 full-year guidance ranges are higher expected revenues from certain of our products with loss of exclusivity, better than expected base performance and improvements in our gross margins, partially offset by higher than expected R&D expenses.

Additional Highlights

Bausch Health’s cash, cash equivalents and restricted cash were $827 million at Sept. 30, 2019

The Company’s availability under the Revolving Credit Facility was approximately $1.055 billion at Sept. 30, 2019

Basic weighted average shares outstanding for the quarter were 352.4 million shares. Diluted weighted average shares outstanding for the quarter were 356.8 million shares5

___________________________________
5 Diluted weighted average shares includes the dilutive impact of options and restricted stock units, which are 4,453,000 common shares for the 3 months ended Sept. 30, 2019, and which are excluded when calculating GAAP diluted loss per share because the effect of including the impact would be anti-dilutive.

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Conference Call Details
Date:
Monday, Nov. 4, 2019
Time:
8:00 a.m. ET
Webcast:
View Source
Participant Event Dial-in:
+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)
Participant Passcode:
0458346
Replay Dial-in:
+1 (877) 344-7529 (United States)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)
Replay Passcode:
10135669 (replay available until Nov. 11, 2019)

On November 4, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the U.S. Food and Drug Administration has cleared its investigational new drug (IND) application for COM902, its immuno-oncology therapeutic antibody targeting TIGIT in patients with advanced malignancies (Press release, Compugen, NOV 4, 2019, View Source [SID1234550216]).

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Under this IND, the Company intends to initiate a Phase 1 clinical trial in patients with advanced malignancies for whom standard of care therapies are currently ineffective. Expected to begin in early 2020, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of COM902. The study is planned to be conducted at multiple centers in the United States and site selection activities are currently underway.

"IND clearance for COM902 is an important milestone that marks the third program based on new drug targets we discovered to be evaluated in the clinic," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that TIGIT inhibitors may have an important role in the immunotherapy landscape and that our biology driven approach of combining anti-TIGIT and anti-PVRIG inhibitors, with or without PD-1 blockers, has the potential to improve clinical responses in patients who are unresponsive and refractory to currently approved immunotherapies. As the only company with clinical candidates targeting both PVRIG and TIGIT, we hold a differentiated position in the crowded immuno-oncology space."

Dr. Cohen-Dayag continued, "We are proud of our tremendous progress in recent years, transforming into a clinical-stage company with three anticipated Phase 1 programs in the clinic expected in 2020, two of which we are being developed internally. Importantly, these three programs address targets which originated from our unique computational discovery platform, highlighting the power and value of our computational capabilities to discover new, potentially significant biological pathways and targets for innovative therapeutics."

About COM902
COM902, a high affinity, fully human antibody targeting TIGIT, was developed for combination treatment with COM701. Preclinical data demonstrate that TIGIT inhibition, either alone or in combination with other checkpoint inhibitors, can enhance T cell activation and increase anti-tumor immune responses. Parallel inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM-1 axis, results in synergistic effects on effector T cell function and tumor growth inhibition in various model systems that can be further increased with the addition of PD-1 blockade. Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition.

Compugen discovered TIGIT in 2009 leveraging its immune checkpoint computational discovery platform through which PVRIG was also discovered. The TIGT discovery was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).