On November 4, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will hold a conference call and live webcast on Monday, November 18, 2019 at 4:30 p.m. Eastern Time (ET) to review its third quarter 2019 financial results and provide a business update (Press release, Ascendis Pharma, NOV 4, 2019, View Source [SID1234551451]).

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Conference Call Details

Date Monday, November 18, 2019
Time 4:30 p.m. ET/1:30 p.m. Pacific Time
Dial In (U.S.) (844) 290-3904
Dial In (International) (574) 990-1036
Access Code 5897398
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

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
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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

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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 MAX BioPharma, Inc. (www.maxbiopharma.com) reported that published two articles describing its anti-tumorigenic oxysterol lead compounds in the peer-reviewed journal, Cells (Press release, MAX BioPharma, NOV 4, 2019, View Source [SID1234550237]). Oxy186 (View Source) and Oxy210 (View Source) are derived from the Company’s Oxysterol Therapeutics platform of proprietary oxysterols. MAX BioPharma is currently optimizing the compounds for oral dosing and performing pre-clinical studies required by the FDA for clinical development and commercialization.

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MAX BioPharma’s anti-tumorigenic oxysterol, Oxy186, inhibits the Hedgehog signaling pathway, which is dysregulated and activated in many human tumors including pancreatic and lung cancers. Oxy210, an analogue of Oxy186, inhibits Hedgehog signaling as well as transforming growth factor (TGF)beta signaling. Oxy210 and Oxy186 have unique mechanisms of action compared to other Hedgehog and TGFbeta signaling inhibitors that are commercially available or under clinical development. MAX BioPharma is focusing its efforts to develop these compounds for lung and pancreatic cancers, which still have huge unmet medical needs. Oxy210 and Oxy186 have favorable pharmacokinetic and safety profiles, are scalable, and were found to inhibit tumor cell growth, invasive activity, and epithelial-mesenchymal transition, a hallmark of cancer metastasis. In addition, Oxy210 was found to inhibit development of chemoresistance by tumor cells and to enhance the cytotoxic effects of carboplatin on lung cancer cells in vitro.

MAX BioPharma has collaborated with Dr. Ying Zhang of the National Cancer Institute (NCI) under a Materials-Cooperative Research and Development Agreement (M-CRADA) and with academic investigators. These collaborations are evaluating the potential of the oxysterols to be potent, orally bioavailable, and safe therapies for cancer. "Given the important role of Hedgehog signaling in acute myeloid leukemia (AML) and the recent FDA approval of a Hedgehog pathway inhibitor, DaurismoTM (glasdegib) by Pfizer, for the treatment of AML, we are excited to begin examining the potential of oxysterols for targeting AML" explains Dr. William Matsui, co-founder of MAX BioPharma and Professor of Oncology and Deputy Director of LIVESTRONG Cancer Institutes at the University of Texas in Austin. MAX BioPharma is seeking strategic partnerships with biotechnology and pharmaceutical companies that have the expertise and resources to further the development of oxysterols as a cancer therapeutic towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A financing round to support the advancement of its therapeutic development programs. "We are extremely excited about the progress of our oncology program and we believe that our findings will be groundbreaking in finding more effective cures for cancer," says Dr. Farhad Parhami, President & CEO of MAX BioPharma.

On November 4, 2019 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported an agreement with Amgen to evaluate the combination of RMC-4630, the company’s investigational SHP2 inhibitor, and AMG 510, Amgen’s investigational KRASG12C inhibitor (Press release, Revolution Medicines, NOV 4, 2019, View Source [SID1234550253]). Amgen will conduct a Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of AMG 510 in combination with RMC‑4630 in subjects with advanced solid tumors harboring the KRASG12C mutation. Revolution Medicines will provide Amgen with clinical supply of RMC-4630 for the planned study.

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RMC-4630 and AMG 510 are selective investigational inhibitors of oncogenic targets at distinct positions within the RAS signaling cascade that are frequently exploited by human cancers. RMC-4630 is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. RMC-4630 and SHP2 are the focus of an exclusive global research, development and commercialization agreement with Sanofi. AMG 510 is designed to selectively and irreversibly target the KRASG12C protein, an oncogenic RAS mutant at the core of the RAS signaling cascade.

Preclinical and clinical research has shown that cancers caused by KRASG12C and other RAS pathway mutations exhibit "oncogene addiction," in which tumor cells are highly dependent on RAS pathway signaling to survive. Such tumors can develop adaptive resistance by hijacking cell signaling circuitry to circumvent pathway inhibitors and restore RAS signaling. The planned clinical Phase 1b study is the first step in evaluating whether inhibition of the RAS pathway at two nodes simultaneously through the combination of RMC-4630 and AMG 510 increases the depth or durability of clinical benefit for patients with tumors bearing KRASG12C.

"We and our partner Sanofi are committed to a clinical strategy that includes exploring in-pathway combinations including RMC-4630 to optimize treatment options for patients with RAS-dependent tumors. This collaboration with Amgen, a clinical pioneer in the field, provides another opportunity to leverage RMC-4630," said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer of Revolution Medicines. "Our development program for RMC-4630 currently includes an ongoing Phase 1 monotherapy trial, an ongoing Phase 1b/2 study evaluating a combination with cobimetinib, a MEK inhibitor, and a planned Phase 1b trial evaluating a combination with AMG 510, the leading investigational KRASG12C inhibitor."

About RMC-4630 and Sanofi Collaboration

RMC-4630 is currently being evaluated in a Phase 1 monotherapy clinical trial (RMC-4630-01) for a range of tumor types featuring specific, molecularly-defined oncogenic mutations, as well as a Phase 1b/2 study (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations. The RMC-4630 program is the focus of an exclusive global research, development and commercialization agreement with Sanofi, under which Revolution Medicines received a $50 million upfront payment, and Sanofi agreed to reimburse the Revolution Medicines for substantially all research and all development costs for the joint SHP2 program. Sanofi received an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote right for Revolution Medicines. The companies have agreed to enter into a 50/50 profit and loss share arrangement in the U.S., and Revolution Medicines is entitled to receive tiered royalties on annual net sales ranging from high single digit to mid-teen percentages on sales in other markets. Revolution Medicines could also receive more than $500 million in development and regulatory milestone payments.

On November 4, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter of 2019 (Press release, NanoString Technologies, NOV 4, 2019, View Source [SID1234550270]).

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Third Quarter Financial Highlights

Total product and service revenue of $26.3 million, 23% year-over-year growth
Instrument revenue of $8.0 million, including $2.2 million of GeoMx DSP instrument revenue, 48% year-over-year growth
Consumables revenue of $15.3 million, including $2.5 million of Prosigna IVD kits, 11% year-over-year growth
Service revenue of $3.1 million, 31% year-over-year growth
Collaboration revenue recognized of $4.3 million and cash received from collaborators of $4.5 million
Updated fiscal 2019 product and service revenue guidance to $100 to $103 million from the previous range of $98 to $103 million, which includes GeoMx DSP revenue guidance at the top end of the previous range
"During the third quarter we achieved the seventh consecutive quarter of double-digit revenue growth in our core nCounter business, driven by strong instrument placements and an expanded consumable portfolio," said Brad Gray, president and CEO of NanoString. "The shipment of our first commercial GeoMx DSP instruments during the third quarter accelerated our instrument revenue growth to more than 40%, and we see positive leading indicators of GeoMx interest including record demand for our GeoMx Technology Access Program."

Recent Business Highlights

nCounter Platform

Increased installed base to approximately 820 nCounter Analysis Systems at September 30, 2019, as compared to approximately 695 systems at September 30 in the prior year.
Surpassed 2,800 cumulative peer-reviewed publications of studies utilizing nCounter technology.
Launched nCounter Human Organ Transplant Panel to study the mechanisms of organ rejection and to monitor the toxicities of immunosuppressive drugs and viral infections.
GeoMx Digital Spatial Profiling (DSP) Platform

Received orders for more than 15 additional GeoMx DSP systems, bringing cumulative orders to more than 70 systems.
Shipped our first ten commercial GeoMx DSP systems during the quarter.
Completed more than 40 GeoMx DSP Technology Access Program (TAP) projects during the third quarter, expanding the total number of projects completed to approximately 170 projects for about 110 unique customers.
GeoMx DSP featured on the cover of the September issue of Clinical Cancer Research, highlighting an article describing research by Dr. David Rimm et al. from Yale University using GeoMx DSP (see accompanying image).
First peer-reviewed publication demonstrating the utility of GeoMx DSP in Neuroscience research.
Leadership

Announced the appointment of Mark Winham as senior vice president of Operations. Mr. Winham was previously vice president of Global Manufacturing for Life Technologies.
Announced the appointment of Don Kania Ph.D., to the Company’s Board of Directors. Dr. Kania was previously the CEO and president of FEI, a leading electron microscopy company.
Third Quarter Financial Results

Product and service revenue for the three months ended September 30, 2019 increased by 23% to $26.3 million, as compared to $21.5 million for the third quarter of 2018. Instrument revenue was $8.0 million, an increase of 48% compared to the prior year period. Consumables revenue, excluding Prosigna, was $12.7 million, an increase of 14% compared to the prior year period, with growth driven primarily by sales of our panel products. Prosigna IVD kit revenue remained flat at $2.5 million as compared to the prior year period. Service revenue was $3.1 million, an increase of 31% compared to the prior year period, reflecting continued growth in demand for our GeoMx DSP Technology Access Program and an increased number of service contracts associated with our growing installed base of nCounter instruments. Gross margin on product and service revenue was 59% compared to 57% in the prior year period, reflecting a mix shift towards our MAX and FLEX nCounter instruments as well as sales of our new GeoMx DSP instruments.

Collaboration revenue totaled $4.3 million, compared to $7.2 million for the prior year period, and was derived primarily from our collaboration with Lam Research. Cash received from collaborators totaled $4.5 million during the quarter, primarily reflecting activity relating to our collaboration with Lam Research and the remaining activities for our Celgene collaboration, which ended during the second quarter of this fiscal year.

Research and development expense increased by 2% to $17.0 million compared to $16.7 million for the prior year period, primarily due to higher stock-based compensation expense. Selling, general and administrative expense increased by 31% to $23.4 million compared to $17.8 million for the prior year period, primarily reflecting increased investment in personnel and commercial launch activities related to GeoMx DSP and higher stock-based compensation expense.

Net loss was $22.7 million, or a loss of $0.64 per share, compared with $16.5 million, or $0.56 per share, for the prior year period.

Outlook for 2019

The company updated its revenue and gross margin guidance for fiscal 2019, with results expected as follows:

Product and service revenue of $100 million to $103 million, including approximately $8 million of revenue recorded from sales of GeoMx DSP, as compared to previous guidance of $98 million to $103 million and $6 to $8 million respectively.
Total revenue of $121 million to $124 million, which includes product and service revenue plus approximately $21 million of collaboration revenue, as compared to previous guidance of $118 million to $123 million and approximately $20 million respectively.
Gross margin on product and service revenue of 58% to 59%, as compared to previous guidance of 57% to 59%.
The company also updated its guidance for certain operating expenses and other items. These updates reflect additional investments directed to capture demand for and support the launch of GeoMx DSP, as well as higher expected stock-based compensation expense. For the full year 2019, the company now expects:

Selling, general and administrative expenses of $92 million to $93 million, as compared to previous guidance of $85 million to $87 million.
Research and development expenses of $66 million to $67 million, as compared to previous guidance of $64 million to $66 million, to be partially offset by approximately $20 million expected to be received from Lam Research.
GAAP net loss of $85 million to $87 million, as compared to previous guidance of $78 million to $83 million.
Net loss per share of $2.40 to $2.50, as compared to previous guidance of $2.20 to $2.40, reflecting the collective impact of the updates described above and the impact of additional shares issued in the offering of common stock completed in March 2019.
Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Individuals interested in listening to the conference call may do so by dialing (866) 211-0364 for domestic callers, or (647) 689-6861 for international callers. Please reference Conference ID 9358402. To listen to a live webcast, please visit the investor relations section of the company’s website at www.nanostring.com. A replay of the call will be available beginning November 4, 2019 at 7:30 pm ET through midnight ET on November 11, 2019. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 9358402. The webcast will also be available on the company’s website for one year following the completion of the call.