On May 9, 2017 VLP Therapeutics, LLC ("VLP"), a biotechnology company focusing on the research and development of therapeutic and preventative vaccines and antibody agents, reported that it completed a convertible note financing with an angel investor Dr. Tomy Kamada, through his investment firm TomyK Ltd., that supports technology startups which pioneer new markets and create new industries with their innovative technologies (Press release, VLP Therapeutics, MAY 9, 2017, View Source [SID1234519827]).

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"We are very pleased with Dr. Kamada’s investment in our company and the successful closing of this financing. His evaluation of and investment in our company affirms the progress we have made to date and the investment will help accelerate our cancer vaccine program, as we prepare for clinical trials," said VLP Therapeutics’ Chief Executive Officer Dr. Wataru Akahata. "The decision by Dr. Tomy Kamada to invest in our company is a testament to the potential of our platform technology, based on the immune checkpoint PD-1/PD-L1/PD-L2 inserted alphavirus. With this investment, combined with strong data we have obtained for our candidate vaccines, we will continue to focus on bringing safe, accessible and effective cancer vaccines to patients as quickly as possible," he continued. Dr. Kamada noted that, "The VLP Therapeutics’ i-αVLP approach presents a breakthrough method that is applicable to a wide range of vaccine developments. I am very pleased to support the i-αVLP vaccine development approach, especially as applied towards cancer vaccines, which has to be one of the most anticipated to therapies in the world."

About i-α VLP Technology

The human immune system is biologically designed to protect us against disease. The immune system detects foreign objects such as viruses, bacteria or abnormal self-tissues (like cancer cells) in the body, and not only tries to eliminate these foreign objects, but also "memorizes" them so it can protect the body from them in the future. Vaccines utilize the immune system to protect us from various diseases.

Traditional vaccines are made using live viruses, which, though rare, can cause serious safety risks. Unlike traditional vaccines, VLP’s novel, proprietary platform technology utilizes virus-like particles. Virus-like particles are identical to the authentic native viruses in their shapes, but do not carry the genetic material of native viruses. Without the genetic material, these particles cannot replicate themselves. This means that when the viruslike particles are presented within our bodies, our immune system will recognize the particles as foreign objects, triggering effective immune responses, but should not cause the risk of side effects associated with the native virus due to the absence of genetic material.

Utilizing these virus-like particles, VLP Therapeutics has developed a proprietary, "plug-and-play" platform called inserted alphavirus virus-like particle (i-αVLP) using the Chikungunya virus (CHIKV) VLP. Through this adaptable platform, foreign antigens can be inserted into two specific sites of the envelope protein on the surface of i-αVLP. With 240 copies of envelope protein per CHIKV VLP, each i-αVLP can display a tremendous 480 copies of an inserted antigen. This highly symmetrical, icosahedral dense array of antigens has been shown in our studies to induce very strong immune responses, resulting in its superior efficacy. VLP Therapeutics has established a method to efficiently produce i-αVLPs which it believes can be scaled for commercial production.

About VLP Therapeutics

VLP Therapeutics, LLC ("VLP") was established in 2012 by seasoned biopharmaceutical veterans with the mission to develop innovative medical treatments which can transform traditional vaccines and targeted antibody therapies to address global unmet medical needs. Its vision is to combat 21st century global public health problems through its revolutionary next generation i-αVLP technology platform. VLP is currently developing preventative and therapeutic vaccines as well as next generation targeted antibody agents to treat cancer, infectious diseases, such as Malaria, Dengue Fever and Zika virus-based diseases, autoimmune and neurological diseases.

About TomyK Ltd.

TomyK Ltd. supports technology startups which pioneer new markets and create new industries with their innovative technologies. Founder and CEO, Dr. Tomy Kamada, was a co-founder of ACCESS Co., Ltd. (listed in Tokyo Stock Exchange: 4813), a global software company for mobile and beyond-PC markets. Dr. Kamada received a Doctorate in 
Computer Science from the University of Tokyo. He is also renowned as an inventor of "Compact HTML"
for mobile phones, enabling successful mobile Internet services in the early days of the Internet. After retiring from ACCESS in 2012, Dr. Kamada founded TomyK Ltd. (View Source) to actively support young, innovative startups, including the areas of Robotics and AI, IoT (Internet of Things), Human Argumentation, Biotechnology, Medical & Life Science, and other frontier technologies.

On May 9, 2017 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) (“Valeant” or the “Company” or “we”) reported first-quarter 2017 financial results (Filing, Q1, Valeant, 2017, MAY 9, 2017, View Source [SID1234519091]).

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“Our first quarter performance demonstrates that we are delivering on our commitments. We met our internal expectations, and we are continuing to make progress on our key initiatives, focus on the turnaround of our core businesses and improve internal operating efficiencies,” said Joseph C. Papa, chairman and chief executive officer, Valeant. “Our divestiture efforts and cash flow generation have led to a $3.6 billion reduction in total debt to date, since the end of the first quarter of 2016, and our successful debt refinancing provides us with a more comfortable maturity profile.”

First-Quarter 2017 Highlights

Strengthening the Balance Sheet
•
Delivered $954 million in cash flow from operations

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International Headquarters
2150 St. Elzéar Blvd. West
Laval, Quebec H7L 4A8
Phone: 514.744.6792
Fax: 514.744.6272

•
Completed more than $1.3 billion in asset sales, including the earlier than expected closure of the sale of the CeraVe, AcneFree and AMBI skincare brands
•
On track to close the sale of Dendreon Pharmaceuticals for $819.9 million in cash proceeds in mid-year
•
Reduced debt of $1.3 billion in the first quarter of 2017; reduced total debt to date by $3.6 billion since the end of the first quarter of 2016
•
Successfully executed a debt refinancing that extended our debt maturity profile, increased our fixed vs. floating rate debt and increased covenant flexibility

Continued Focus on Core Business
•
Obtained approval for SILIQ (brodalumab) from the U.S. Food and Drug Administration (FDA) and announced it will be the most competitively priced injectable biologic for moderate-to-severe plaque psoriasis when it launches later this year
•
Advanced Bausch + Lomb business
◦
Received FDA 510(k) clearance for Vitesse
◦
Received FDA 510(k) clearance for Stellaris Elite
◦
Introduced Bausch + Lomb ULTRA for Astigmatism contact lenses
◦
Expanded parameters for Bausch + Lomb ULTRA for Presbyopia contact lenses
◦
Received FDA filing acceptance with Nicox S.A. for Vyzulta1 (latanoprostene bunod) for glaucoma with a PDUFA action date of August 24, 2017
◦
Received FDA filing acceptance for Luminesse1 (brimonidine tartrate ophthalmic solution, 0.025%) with a PDUFA action date of December 27, 2017
◦
Entered into an exclusive, worldwide licensing agreement for the EyeGate II Delivery System and EGP-437 combination product candidate for the treatment of post-operative pain and inflammation in ocular surgery patients
•
Stabilized average realized pricing within our dermatology business
•
Expanded Salix sales force to reach untapped market potential in primary care
•
Grew Bausch + Lomb Vision Care business in Australia, China and Japan, with notable 11% volume growth in China
•
Announced new skincare product line collaboration with Suzan Obagi, M.D., and Nextcell Medical Company
____________________________________
1 Provisional name

First-Quarter Revenue Performance

Total revenues were $2.109 billion for the first quarter of 2017 as compared to $2.372 billion in the first quarter of 2016, a decrease of $263 million, or 11%. The decline was primarily driven by lower volumes in our U.S. Diversified Products and Branded Rx segments as a result of the loss of exclusivity for a number of products and challenging market dynamics. Revenues were also negatively affected by foreign currencies, divestitures and discontinuations, and a modest decrease in average realized pricing. These decreases were partially offset by increased volumes in our Bausch + Lomb/International segment, mainly in Europe, the Middle East, South Africa, China and Australia.

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International Headquarters
2150 St. Elzéar Blvd. West
Laval, Quebec H7L 4A8
Phone: 514.744.6792
Fax: 514.744.6272

Revenues by segment were as follows:

Three Months Ended March 31
(in millions)

2017

2016

Reported Change

Currency Impact

Constant Currency Change2
Segment Revenues

Bausch + Lomb/International

$
1,150

$
1,146

$
4

$
(41
)

$
45

Branded Rx

604

665

(61
)

–

(61
)
U.S. Diversified Products

355

561

(206
)

–

(206
)
Total revenues

$
2,109

$
2,372

$
(263
)

$
(41
)

$
(222
)
____________________________________
2 To assist investors in evaluating the Company’s performance, we have adjusted for foreign currency effects. Constant currency impact is determined by comparing 2017 reported amounts adjusted to exclude currency impact, calculated using 2016 monthly average exchange rates, to the actual 2016 reported amounts.

Bausch + Lomb/International Segment

The Bausch + Lomb/International segment revenues were $1.15 billion for the first quarter of 2017 as compared to $1.146 billion for first quarter of 2016, an increase of $4 million, or less than 1%. Growth was 4% on a constant currency basis. Gains were primarily driven by increases in our international volumes, particularly in Europe, the Middle East, South Africa, Asia and Australia, of $59 million, partially offset by declines in U.S. Bausch + Lomb volumes of $10 million. Average realized pricing across the segment increased $16 million mainly from the international business units. The U.S. Bausch + Lomb units saw average realized pricing increase by less than $1 million. Volume and pricing gains were partially offset by the unfavorable impact of foreign currencies of $41 million and the impact of divestitures and discontinuations of $21 million.

Branded Rx Segment

The Branded Rx segment revenues were $604 million for the first quarter of 2017 as compared to $665 million in the same period in 2016, a decrease of $61 million, or 9%. The decrease was primarily driven by decreased volumes in the dermatology and Salix business units due to the loss of exclusivity of certain product lines, continued generic competition and the impact of an increase in the prevalence of high deductible medical plans. The decrease in overall volume was partially offset by an increase in average realized prices across the segment. Pricing improved in the dermatology business, driven by lower customer subsidies and accommodations and higher wholesaler selling prices. In the Salix business, we benefited from higher wholesale selling prices and from favorable chargebacks during the quarter. These increases were partially offset by higher managed care rebates particularly in the dermatology business. Segment revenues were also impacted by $7 million as a result of the divestiture of Ruconest.

U.S. Diversified Products Segment

The U.S. Diversified Products segment reported first-quarter 2017 revenues of $355 million as compared to $561 million in the first quarter of 2016, reflecting a decline of $206 million, or 37%. The decrease was primarily driven by

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International Headquarters
2150 St. Elzéar Blvd. West
Laval, Quebec H7L 4A8
Phone: 514.744.6792
Fax: 514.744.6272

a $157 million decrease in volume and lower average realized prices of $47 million. The declines in both volume and average realized price were primarily driven by loss of exclusivity for products in the segment.

GAAP Operating Income

Operating income was $211 million for the first quarter of 2017 as compared to $66 million for the first quarter of 2016, an increase of $145 million. The decrease in operating expenses includes higher direct-to-consumer advertising expenses for Jublia and Xifaxan in the first quarter of 2016, which was partially offset by a higher run rate in general and administrative (G&A) expenses and asset impairments.

GAAP Net Income (Loss)

Net income for the three months ended March 31, 2017 was $628 million as compared to a net loss of ($374) million for the same period in 2016, an increase of $1.002 billion. Net income in the first quarter of 2017 includes a one-time income tax benefit of $908 million from a non-cash internal restructuring that occurred during this time. In addition, net income included the loss on extinguishment of debt of $64 million associated with our debt refinancing and repurchases that occurred in the first quarter of 2017 and an increase in interest expense of $47 million, primarily from the increase in interest rates associated with amendments to our credit agreements in 2016.

Adjusted EBITDA (non-GAAP)

Adjusted EBITDA (non-GAAP) was $861 million for the first quarter of 2017 as compared to $1.008 billion for the first quarter of 2016, a decrease of $147 million, primarily due to the loss of exclusivity for products in the U.S. Diversified Products segment.

GAAP Earnings Per Share (EPS) – Diluted

GAAP EPS – Diluted for the first quarter of 2017 came in at $1.79 as compared to $(1.08) in the first quarter of 2016.

GAAP Cash Flow from Operations

Cash provided by operating activities was $954 million for the first quarter of 2017, attributable to changes in our working capital and cash we received from our fulfillment arrangement with Walgreens.

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International Headquarters
2150 St. Elzéar Blvd. West
Laval, Quebec H7L 4A8
Phone: 514.744.6792
Fax: 514.744.6272

2017 Guidance

Valeant has raised guidance for 2017, as follows:

•
2017 Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.60 – $3.75 billion from $3.55 – $3.70 billion

This guidance reflects the impact of the sale of the CeraVe, AcneFree and AMBI skincare brands. This guidance does not reflect the impact of the sale of the Dendreon business, which is expected to close mid-year.

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, that 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 amounts 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). As previously discussed, the Company is no longer providing guidance with respect to Adjusted Net Income or Adjusted EPS.

Reducing and Refinancing Debt

In the first quarter of 2017, we successfully executed a debt refinancing that extended our debt maturity profile, increased our fixed vs. floating rate debt and increased flexibility under our debt covenants. During the quarter, the Company reduced its outstanding debt by $1.3 billion.

These transactions and debt payments have had the effect of lowering our cash requirements for principal debt payments over the remainder of 2017 through 2020 by an aggregate $6.32 billion, providing us with a much improved liquidity profile during this timeframe and greater flexibility to execute our business plans. In April 2017, we announced that we reduced our term loans under our Senior Secured Credit Facilities by approximately an additional $220 million.

Valeant’s corporate credit ratings remained unchanged during the first quarter of 2017. The Company’s availability under the Revolving Credit Facility was approximately $925 million at March 31, 2017.

Other Matters

•
The Company’s cash and cash equivalents were $1.210 billion at March 31, 2017.
•
Richard DeSchutter, prior chairman and chief executive officer of DuPont Pharmaceuticals Company, joined the Valeant Board of Directors.

On May 10, 2017 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported its financial results and recent corporate highlights for the quarter ended March 31, 2017 (Press release, Fortress Biotech, MAY 9, 2017, View Source [SID1234519030]).

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Dr. Lindsay A. Rosenwald, Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress had a strong start to 2017, with the launch of our subsidiaries Caelum Biosciences and Cyprium Therapeutics, which we believe strengthens our rare disease portfolio. Importantly, we announced a Cooperative Research and Development Agreement between Cyprium and the NICHD to advance the clinical development of Cyprium’s Phase 3 candidate CUTX ‐ 101 in Menkes disease, a rare and devastating pediatric illness. We also reported that Caelum announced the dosing of the final patient in its Phase 1b study of CAEL ‐ 101 for the treatment of AL amyloidosis, a fatal orphan disease that affects organ function. In addition, our established subsidiaries continued to deliver on key milestones, including Mustang Bio raising a total of approximately $95.0 million in private placement financings to support its CAR T pipeline. We look forward to the continued clinical advancement of our Fortress Companies, and are evaluating opportunities to expand our portfolio through compelling new indications and in ‐ licensing opportunities." Financial Results:  As of March 31, 2017, Fortress’ consolidated cash and cash equivalents totaled $134.0 million compared to $88.3 million at December 31, 2016, an increase of $45.7 million for the quarter. These totals exclude restricted cash of $15.9 million and cash deposits with clearing organizations of $1.0 million.  Net revenue totaled $44.7 million for the first quarter of 2017, compared to $0.7 million for the first quarter of 2016. Net total revenue as of March 31, 2017 includes $2.8 million of Fortress revenue and $41.9 million of revenue from National Holdings Corporation ("National"), which we acquired in September 2016, with no revenue attributable to National prior to the acquisition.  Research and development expenses were $7.1 million for the first quarter of 2017, of which $6.0 million was related to Fortress Companies. This compares to $7.7 million for the first quarter of 2016, of which $6.0 million was related to Fortress Companies. Non ‐ cash stock ‐ based compensation expenses included in research and development were $0.8 million for the first quarter of 2017, and $1.3 million for the first quarter of 2016.  Research and development expenses from license acquisitions totaled $1.3 million for the first quarter of 2017, compared to $0.1 million for the first quarter of 2016.  General and administrative expenses were $10.3 million for the first quarter of 2017, of which $7.1 million was related to Fortress Companies. This compares to $7.9 million for the first quarter of 2016, of which $4.0 million was related to Fortress Companies. Non ‐ cash stock ‐ based compensation expenses included in general and administrative expenses were $2.1 million for the first quarter of 2017, and $1.6 million for the first quarter of 2016.  National’s operating expenses totaled $43.1 million for the first quarter of 2017, with no expenses attributable to National prior to our acquisition of the company in September 2016.  Net loss attributable to common stockholders was $12.0 million, or $0.30 per share, for the first quarter of 2017, compared to a net loss attributable to common stockholders of $12.2 million, or $0.31 per share, for the first quarter of 2016. Recent Fortress Biotech and Fortress Company Highlights: Fortress Biotech, Inc.  Fortress recently launched two new Fortress Companies: Caelum Biosciences to develop therapies for amyloid light chain ("AL") amyloidosis, and Cyprium Therapeutics to develop novel therapies for the treatment of Menkes disease and related copper metabolism disorders.
Avenue Therapeutics, Inc.
In February 2017, two continuation patents covering methods of administration for intravenous tramadol for the treatment of acute pain were issued by the U.S. Patent and Trademark Office ("USPTO").
Caelum Biosciences, Inc.
In January 2017, Michael Spector was appointed Chief Executive Officer and a member of the Board of Directors of Caelum.
In January 2017, Caelum entered into an agreement with Columbia University ("Columbia") to secure exclusive worldwide license rights to CAEL ‐ 101, a chimeric fibril ‐ reactive monoclonal antibody.
In April 2017, the U.S. Department of Health & Human Services confirmed the transfer of two U.S. Food and Drug Administration ("FDA") Orphan Drug Designations for CAEL ‐ 101 from Columbia to Caelum. The designations cover use as a therapeutic agent for patients with AL amyloidosis and use as a radio ‐ imaging agent in amyloidosis.
In May 2017, Columbia dosed the final patient in the Phase 1b trial of CAEL ‐ 101. Preliminary Phase 1b data are expected mid ‐ 2017, with full data anticipated by the end of the year.
Checkpoint Therapeutics, Inc.
In February 2017, the USPTO issued a composition of matter patent for CK ‐ 101, an oral, third ‐ generation epidermal growth factor receptor ("EGFR") inhibitor in development for the treatment of EGFR mutation ‐ positive non ‐ small cell lung cancer.
In April 2017, preclinical data on CK ‐ 101 and anti ‐ programmed cell death ligand ‐ 1 ("PD ‐ L1") antibody, CK ‐ 301, were presented in poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Cyprium Therapeutics, Inc.
In March 2017, Lung Yam, M.D., Ph.D., was appointed Chief Executive Officer and a member of the Board of Directors of Cyprium.
In March 2017, Cyprium entered into a Cooperative Research and Development Agreement ("CRADA") with the Eunice Kennedy Shriver National Institute of Child Health and Human Development ("NICHD"), part of the National Institutes of Health ("NIH"), to advance the clinical development of Phase 3 candidate CUTX ‐ 101 (Copper Histidinate injection) for the treatment of Menkes disease.
Also effective in March 2017, Cyprium and the NICHD entered into a worldwide, exclusive license agreement to develop and commercialize the adeno ‐ associated virus ("AAV") ‐ based gene therapy AAV ‐ ATP7A to deliver working copies of the copper transporter that is defective in Menkes patients. AAV ‐ ATP7A will be used in combination with CUTX ‐ 101.
Mustang Bio, Inc.
From October 2016 to March 2017, Mustang closed on a total of approximately $95.0 million in private placement financings, prior to fees and expenses.
In April 2017, Mustang appointed Manuel Litchman, M.D., as President and Chief Executive Officer, as well as a member of the Board of Directors