VIVUS Reports Fourth Quarter 2017 Financial Results

CAMPBELL, CA—(Marketwired – March 13, 2018) – VIVUS,Inc. (NASDAQ: VVUS) (the “Company”), a biopharmaceutical company committed to the development and commercialization of innovative therapies focusing on treatments for patients with serious unmet medical needs, today reported financial results for the quarter and year ended December 31, 2017 and provided a business update.

“Throughout 2017, we executed on strategies intended to expand our pipeline and maximize our legacy assets. Achievements in these areas include advancing tacrolimus toward the clinic, with a phase 2 trial start scheduled for the second half of 2018, and our marketing agreement for Qsymia® in the Republic of Korea,” said Thomas B. King, VIVUS' interim Chief Executive Officer. “We move into 2018 with continued efforts to monetize our current assets, identify additional assets to enhance our pipeline and financial resources, and ultimately create value for patients and stockholders.”

Recent Business Highlights

  • VIVUS Management Transition

    On December 31, 2017, VIVUS board member Thomas B. King was appointed to the role of CEO on an interim basis. VIVUS' Board is working with an executive search firm to identify a permanent CEO with the passion and vision to help VIVUS succeed in the execution of its strategies.

  • Tacrolimus Hits Key Milestones

    In October 2017, the Company announced that it held a pre–IND meeting with the U.S. Food and Drug Administration (FDA) for its proprietary formulation of tacrolimus for the treatment of pulmonary arterial hypertension (PAH). The FDA addressed VIVUS' questions related to preclinical, nonclinical and clinical data, planned design of clinical trials of tacrolimus in class III and IV PAH patients, and clarified the requirements needed to file an IND to initiate a clinical trial in this indication. VIVUS is on track to file this IND in the first half of 2018. As discussed with the FDA, VIVUS currently intends to design and conduct clinical trials that could qualify for Fast Track and/or Breakthrough Therapy designation.

2018 Strategic Objectives

  • Continue to expand the Company's clinical and commercial portfolios, with a particular emphasis on cash flow–generating assets
  • Continue monetization of VIVUS' legacy assets
  • Recruit and hire a permanent CEO
  • Initiate the tacrolimus Phase 2 clinical trial in the second half of 2018

Financial Results

Net loss for the fourth quarter of 2017 was $10.1 million, as compared to net income of $56.6 million in the fourth quarter of 2016. Cash, cash equivalents and available–for–sale securities were $226.3 million at December 31, 2017.

Total revenue, net for the fourth quarters of 2017 and 2016, was $11.9 million and $81.8 million, respectively. The decrease was primarily a result of lower license and milestone revenue recognized in the fourth quarter of 2017 as compared to 2016. Revenue consisted of the following:

    Three Months Ended
    December 31,
    2017   2016
Qsymia, net product revenue   $ 8,934   $ 11,046
License and milestone revenue         69,400
STENDRA/SPEDRA supply revenue     2,343     765
STENDRA/SPEDRA royalty revenue     664     594
  Total revenue   $ 11,941   $ 81,805

Beginning in the first quarter of 2017, with 48 months of returns experience, VIVUS believed that it had sufficient data and experience from selling Qsymia to reliably estimate expected returns. As a result, VIVUS changed its revenue recognition methodology for Qsymia sales from a “sell–through” methodology to a “sell–in” methodology.

Approximately 91,000 and 100,000 Qsymia prescriptions were dispensed in the fourth quarters of 2017 and 2016, respectively. In the fourth quarter of 2017, VIVUS shipped approximately 88,000 units of Qsymia to the wholesalers as wholesalers continued to reduce their Qsymia inventory levels. VIVUS recognized approximately $0.3 million less Qsymia revenue under the “sell–in” methodology than would have been recognized under the “sell–through” methodology. The “sell–in” methodology could continue to result in higher volatility of Qsymia sales, as wholesalers adjust inventory levels compared to those historically reported.

Total cost of goods sold was $3.9 million and $2.2 million in the fourth quarters of 2017 and 2016, respectively. The increase was primarily a result of higher STENDRA/SPEDRA supply revenue during the fourth quarter of 2017.

Research and development expense was $1.2 million and $1.8 million in the fourth quarters of 2017 and 2016, respectively. Research and development expenses were impacted by a decrease in efforts surrounding our Qsymia regulatory requirements partially offset by development efforts of tacrolimus for the treatment of PAH.

General and administrative expense was $5.7 million and $9.3 million for the fourth quarters of 2017 and 2016, respectively, while selling and marketing expense for the commercialization of Qsymia totaled $3.0 million and $3.8 million in the fourth quarters of 2017 and 2016, respectively. The decreases were due to the continued cost control initiative and the result of the realignment of our sales force and refinement of our marketing and promotional programs.

About Qsymia

Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced–calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight–related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over–the–counter drugs, and herbal preparations, have not been established.

Important Safety Information

Qsymia® (phentermine and topiramate extended–release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

About Avanafil

STENDRA® (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Metuchen Pharmaceuticals LLC has exclusive marketing rights to STENDRA in the U.S., Canada, South America and India.

STENDRA is available through retail and mail order pharmacies.

SPEDRA™, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin–Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian–Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.

For more information about STENDRA, please visit

Important Safety Information

STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED).

Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.

Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.

STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin.

In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long–term injury.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.

Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti–hypertensives, your doctor may start you on a lower dose of STENDRA.

Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.

STENDRA in combination with other treatments for ED is not recommended.

STENDRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of STENDRA are headache, flushing, runny nose and congestion.

Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.


VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit

Certain statements in this press release are forward–looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long–term stockholder value, including the evaluation of development opportunities; risks and uncertainties related to our, or our partner's, ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to successfully develop or acquire a proprietary formulation of tacrolimus as a precursor to the clinical development process; risks and uncertainties related to our ability to identify, acquire and develop new product pipeline candidates; risks and uncertainties related to our ability to develop a proprietary formulation and to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates; risks and uncertainties related to the timing, strategy, tactics and success of the commercialization of STENDRA (avanafil) by our sublicensees; risks and uncertainties related to our ability to successfully complete on acceptable terms, and on a timely basis, avanafil partnering discussions for territories under our license with MTPC in which we do not have a commercial collaboration; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; and risks and uncertainties related to the impact, if any, of changes to our senior management team. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward–looking statements. The reader is cautioned not to rely on these forward–looking statements. Investors should read the risk factors set forth in VIVUS' Form 10–K for the year ended December 31, 2017 as filed on March 13, 2018, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward–looking statements.

(In thousands, except per share data)
    Three Months Ended   Year Ended
    December 31,   December 31,
    2017     2016   2017     2016
  Net product revenue   $ 8,934     $ 11,046   $ 44,983     $ 48,501
  License and milestone revenue           69,400     7,500       69,400
  Supply revenue     2,343       765     10,407       2,291
  Royalty revenue     664       594     2,483       4,066
    Total revenue     11,941       81,805     65,373       124,258
Operating expenses:                            
  Cost of goods sold     3,936       2,186     17,187       10,602
  Research and development     1,204       1,771     5,263       5,592
  Selling, general and administrative     8,681       13,125     40,130       52,379
    Total operating expenses     13,821       17,082     62,580       68,573
(Loss) income from operations     (1,880 )     64,723     2,793       55,685
    Interest expense and other expense, net     8,190       8,104     33,302       32,313
(Loss) income before income taxes     (10,070 )     56,619     (30,509 )     23,372
Provision (benefit) for income taxes     5       56     2       70
  Net (loss) income   $ (10,075 )   $ 56,563   $ (30,511 )   $ 23,302
Basic net (loss) income per share   $ (0.10 )   $ 0.54   $ (0.29 )   $ 0.22
Diluted net (loss) income per share   $ (0.10 )   $ 0.54   $ (0.29 )   $ 0.22
Shares used in per share computation:                            
  Basic     105,941       104,852     105,741       104,385
  Diluted     105,941       105,338     105,741       104,969
(In thousands)
    December 31,     December 31,  
    2017     2016*  
ASSETS   (Unaudited)        
Current assets:            
  Cash and cash equivalents   $ 66,392     $ 84,783  
  Available–for–sale securities     159,943       184,736  
  Accounts receivable, net     12,187       9,478  
  Inventories     17,712       16,186  
  Prepaid expenses and other assets     7,178       8,251  
    Total current assets     263,412       303,434  
Property and equipment, net     542       788  
Non–current assets     1,014       1,554  
    Total assets   $ 264,968     $ 305,776  
Current liabilities:                
  Accounts payable   $ 10,072     $ 4,707  
  Accrued and other liabilities     21,475       15,686  
  Deferred revenue     2,075       19,174  
  Current portion of long–term debt     5,147       8,708  
    Total current liabilities     38,769       48,275  
  Long–term debt, net of current portion     230,536       232,610  
  Deferred revenue, net of current portion     4,674       6,449  
  Non–current accrued and other liabilities     327       257  
    Total liabilities     274,306       287,591  
Commitments and contingencies                
Stockholders' (deficit) equity:                
  Common stock and additional paid–in capital     834,835       831,855  
  Accumulated other comprehensive loss     (608 )     (616 )
  Accumulated deficit     (843,565 )     (813,054 )
    Total stockholders' (deficit) equity     (9,338 )     18,185  
    Total liabilities and stockholders' (deficit) equity   $ 264,968     $ 305,776  
* The Condensed Consolidated Balance Sheets have been derived from the Company's audited financial statements at that date, as adjusted.

Primero Announces Shareholders Vote in Favour of Transaction With First Majestic

TORONTO, ON—(Marketwired – March 13, 2018) – Primero Mining Corp. (“Primero” or the “Company”) (TSX: P) and First Majestic Silver Corp. (“First Majestic”) (TSX: FR) (NYSE: AG) are pleased to announce that Primero's shareholders have voted in favour of the arrangement transaction (the “Transaction”) at a special meeting of shareholders held earlier today. In addition, holders of Primero's 5.75% convertible unsecured subordinated debentures due February 28, 2020 (the “Primero Debentures”) have, at their meeting today, also voted overwhelmingly in favour of the proposed amendment of the trust indenture to accelerate the maturity date of the debentures to the next Business Day (as defined in the trust indenture) following the effective date of the Transaction.

The Transaction, whereby First Majestic will, among other matters, acquire all of the outstanding common shares of Primero, was approved by more than 99% of votes cast by Primero shareholders. A copy of the complete report on voting will be made available on SEDAR.

The amendment of the trust indenture to accelerate the maturity date of the Primero Debentures to the next Business Day following the effective date of the Transaction was approved by 100% of the votes cast by Primero debentureholders.

The Company will now seek a final order from the Supreme Court of British Columbia to approve the Transaction. The Transaction is expected to close before the end of April 2018, subject to applicable regulatory approvals (including anti–trust clearance in Mexico) and the satisfaction of other customary conditions.

Joseph F. Conway, Interim President and Chief Executive Officer of Primero added, “We are very pleased at the overwhelming support by our stakeholders for this transaction with First Majestic. It provides our shareholders an attractive immediate premium as well as retaining exposure to the high quality, long–lived San Dimas asset that they invested in, with the benefit of a significantly reduced stream. Our debentureholders will also benefit by being paid out at par plus accrued interest.”

“The acquisition of Primero adds one of Mexico's largest and richest precious metals mines to our portfolio and further enhances our growth profile. We are very pleased with the strong support for the transaction and expect to create significant value for shareholders as we continue to unlock its significant regional exploration potential,” said Keith Neumeyer, President and Chief Executive Officer of First Majestic.

About Primero

Primero Mining Corp. is a Canadian–based precious metals producer that owns 100% of the San Dimas gold–silver mine in Mexico. Primero's website is

About First Majestic

First Majestic is a mining company focused on growing primary silver production in Mexico and is aggressively pursuing the development of its existing mineral property assets. First Majestic presently owns and operates six producing silver mines; the La Parrilla Silver Mine, the San Martin Silver Mine, the La Encantada Silver Mine, the La Guitarra Silver Mine, Del Toro Silver Mine and the Santa Elena Silver/Gold Mine. Production from these six mines is projected to be between 10.0 to 10.6 million ounces of pure silver or 15.7 to 16.6 million ounces of silver equivalents for 2017.

For further information, contact, visit our website at or Investor Relations at 1.866.529.2807.


This news release contains forward–looking information under applicable Canadian securities laws (“forward–looking statements”), which may include, without limitation, the current expectations of management of Primero about whether conditions to the consummation of the Transaction will be satisfied, the final approval of the Transaction from the Supreme Court of British Columbia, final antitrust clearance from Mexico and the timing for completing the Transaction. The forward–looking statements are based on the beliefs of management and reflect Primero's current expectations. When used in this news release, the words “estimate”, “project”, “belief”, “anticipate”, “intend”, “expect”, “plan”, “may”, “will” or “should” and the negative of these words or such variations thereon or comparable terminology are intended to identify forward–looking statements. Such statements reflect the current view of Primero. Completion of the Transaction is subject to a number of conditions which are typical for transactions of this nature. Failure to satisfy any of these conditions, as well as court approval, may result in the termination of the Transaction.

By their nature, forward–looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward–looking statements. Forward–looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made, and Primero undertakes no obligation to update forward–looking statements (unless required by law) if these beliefs, estimates and opinions or other circumstances should change. Investors are cautioned against attributing undue certainty to forward–looking statements.

Primero has also assumed that the material factors and assumptions will not cause any forward–looking statements to differ materially from actual results or events. However, the list of these factors and assumptions is not exhaustive and is subject to change and there can be no assurance that such assumptions will reflect the actual outcome of such items or factors.

Attachment Available:–18_Shareholder_Vote_Final–d78cf42537d591069a6a787285308660.pdf

Rodizio Grill(R) To Reopen at The Liberty Center

SALT LAKE CITY, UT—(Marketwired – March 13, 2018) – Rodizio Grill® is reopening its location at the Liberty Center in Liberty Township, OH this spring.

Rodizio Grill – Liberty Center is opening under new franchise ownership of George Chaposky, who has been successfully operating Rodizio Grill in Columbus, OH for nearly six years. “Our Columbus location is truly the embodiment of our core values and mission statement,” stated Ivan Utrera, Founder and President of Rodizio Grill. In 2014, Rodizio Grill – Columbus was named Best in Nation for displaying the following: Extraordinary Guest Service & Atmosphere; Excellent Food Quality & Dining Experience; Exceptional Community Involvement. Today, this location continues to operate in excellence. “George and his experienced management team will bring this to our Liberty Center location offering guests an authentic Brazilian dining experience for which we've been known for over 20 years,” Utrera said.

Established in 1995, Rodizio Grill was the first Brazilian “churrascaria” steakhouse in the United States. The brand remains known for its playful Brazilian spirit, authentic menu offerings and family–friendly atmosphere. The unique concept features rotisserie grilled meat, expertly seasoned and carved tableside by traditionally dressed Gauchos. While the meats are the main attraction, they are complemented with an award–winning gourmet salad bar, marked by original salads, fresh seasonal fruits and vegetables, and authentic hot side dishes. Rodizio Grill also boasts an unparalleled selection of real, fresh–pressed juices, homemade Brazilian Limeades, signature cocktails and an extensive wine list featuring a variety of Brazilian imported wines. At the end of the meal, guests can enjoy a selection of exclusive, homemade desserts authentic to the entire experience — a treat not found anywhere else.

For more information, visit

About Rodizio Grill®:
Established in 1995, Rodizio Grill® The Brazilian Steakhouse™ is the first authentic Brazilian steakhouse in the U.S., founded by Ivan Utrera who wanted to bring this popular Brazilian Churrascaria concept, along with cherished family recipes, to the USA from his home country of Brazil. Rodizio Grill's all–inclusive menu offers unlimited Brazilian sides, over 30 gourmet salads, and rotisserie grilled meats and grilled items, carved tableside by Rodizio Gauchos. For more information, visit

Building Markets Transforms Entrepreneurial Learning Across the Globe With D2L

WATERLOO, ON—(Marketwired – March 13, 2018) – D2L, the global learning technology leader, today announced that nonprofit Building Markets is leveraging its learning platform, Brightspace, to train local businesses in countries affected by crisis.

Building Markets is a nonprofit organization that creates jobs and peace by connecting local small– and medium–sized enterprises (SMEs) to supply chains and investment. A core component of the organization's strategy is to ensure local SMEs and organizations can acquire the skills needed to become competitive firms that can grow and strengthen their country's economy. With D2L, Building Markets will be able to provide digital learning experiences for the first time in the organization's history — which will significantly enhance its training capacity.

Building Markets will leverage D2L to provide self–paced training on a range of skillsets, including human resources, accounting and business management, data analysis, governance, sales and marketing, and more. The platform will also allow one–on–one discussion and mentoring opportunities between trainers and learners to increase course engagement and effectiveness.

“To date, our teams have supported over 4,000 SMEs across the globe through in–person training and mentorship. D2L will help us expand our reach, particularly in markets where local businesses and organizations may be unable to attend in–person courses. It will allow us to gain new insights into the rapidly changing needs of our partners and participants, and measure impact,” said Jennifer P. Holt, CEO of Building Markets.

“We are thrilled to be working with Building Markets to help local entrepreneurs gain the skills and expertise they need to thrive,” said John Baker, President and CEO of D2L. “By providing access to digital training and mentoring on D2L, Building Markets is opening up a world of possibility for the next generation of entrepreneurs to build their businesses, create jobs and contribute to economic growth.”

Additional Information

  • To learn more about how D2L transforms learning, visit
  • Find out more about Building Markets' initiatives at


D2L's Brightspace is a cloud–based learning platform that makes learning easy, flexible and smart. Brightspace is not like a traditional Learning Management System (LMS) — it is easy to create engaging courses and content, integrate video, personalize learning, capture and share expertise across the organization, and supports all mobile devices. Plus, Brightspace enables the future of learning with adaptive learning, intelligent agents, course interactives, full support for competency–based learning and world–leading learning analytics. Our clients report improved productivity, performance growth, lower turnover of employees, greater engagement and ultimately better business outcomes.


D2L believes learning is the foundation upon which all progress and achievement rests. Working closely with organizations globally, D2L has transformed the way millions of people learn online and in the classroom. Learn more about D2L for schools, higher education and businesses at

© 2018 D2L Corporation

The D2L family of companies includes D2L Corporation, D2L Ltd, D2L Australia Pty Ltd, D2L Europe Ltd, D2L Asia Pte Ltd, and D2L Brasil Soluções de Tecnologia para Educação Ltda.

All D2L marks are trademarks of D2L Corporation. Please visit for a list of D2L marks.

Avaya Ends the Gap between Unified Communications and Team Collaboration

ORLANDO, FL—(Marketwired – March 13, 2018) – Enterprise Connect – Avaya Holdings Corp. (NYSE: AVYA) today announced the addition of cloud–based team collaboration to the Avaya Equinox Experience, the company's signature unified communications and collaboration user interface and cloud service. The Avaya Equinox Experience leapfrogs other vendors' offerings by delivering deep level of integration between unified communications and the tools needed for seamless, simple, highly productive team collaboration.

The Avaya Equinox Experience is a sleek, personal user interface for one–stop access to voice, video, chat communications channels, calendar, meetings and more. Its “mobile–first” Top of Mind screen provides at–a–glance visibility to everything that a user needs in real time: schedule, contacts, messages, voice and video.

The new capabilities of Avaya Equinox Experience address the growing demand for easy–to–use, integrated, unified communication and team collaboration. According to Gartner, “by year–end 2022, 70% of teams will rely on workstream collaboration as the primary means of communicating, coordinating and sharing information between team members, displacing email.”

With the addition of team collaboration, Avaya Equinox users can create and enter team rooms organized by a variety of categories with members both inside and outside of the organization, essentially breaking down the boundaries of a company's communications infrastructure. The enhanced Avaya Equinox Experience will provide and support persistent messaging, ad hoc and scheduled meetings, with audio and video conferencing, screen and file sharing and task assignment.

As an example, a sales team creating a proposal could use Avaya Equinox team collaboration and create rooms for customer presentation and demonstration planning, configuration and bill of materials, project pricing and discounts, contracts, installation planning and services. The sales team could invite both internal and external team members for an easy, persistent and trackable means of communicating, individual or group meetings, sharing presentations, spreadsheets, installation diagrams, and speeding decision–making.

An enterprise–grade solution, Avaya Equinox provides a higher level of security over consumer–grade messaging and applications. The cloud–based, team collaboration capabilities are available standalone and also easily integrate with on–premises deployments of Avaya Equinox supported by both Avaya Aura and Avaya IP Office, Avaya's industry–leading communications platforms.


“The market is rife with applications claiming to enable employee productivity, but few deliver the level of integration that crosses communication channels and modes, context and contacts, workflow activities and infrastructure boundaries. That's where the Avaya Equinox Experience stands out — and is why companies are coming back to Avaya for the communication and collaboration tools that get work done. Welcome to the Avaya Connected World — open, agile and secure.”

Laurent Philonenko, SVP and GM, Solutions and Technologies, Avaya

“Enterprises are clearly shifting toward messaging–based communications tools. By integrating workstream collaboration into its UC Equinox client, Avaya creates a single–application that supports asynchronous messaging and real–time voice and video communications that can serve as a vehicle for sharing content.”

Dave Michels, principal analyst, TalkingPointz

About Avaya

Avaya is a global leader in digital communications software, services and devices for businesses of all sizes. Our open, intelligent and customizable solutions for contact centers and unified communications offer the flexibility of Cloud, on–premises and hybrid deployments. Avaya shapes intelligent connections and creates seamless communication experiences for our customers, and their customers. Our professional planning, support and management services teams help optimize solutions, for highly reliable and efficient deployments. Avaya Holdings Corp. is traded on the NYSE under the ticker AVYA. For more information, please visit

Cautionary Note Regarding Forward–Looking Statements

This document contains certain “forward–looking statements.” All statements other than statements of historical fact are “forward–looking” statements for purposes of the U.S. federal and state securities laws. These statements may be identified by the use of forward looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “our vision,” “plan,” “potential,” “preliminary,” “predict,” “should,” “will,” or “would” or the negative thereof or other variations thereof or comparable terminology and include, but are not limited to, availability and effectiveness of new products and features. The Company has based these forward–looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward–looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond its control. The factors are discussed in the Company's Registration Statement on Form 10 filed with the Securities and Exchange Commission, may cause its actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward–looking statements. For a further list and description of such risks and uncertainties, please refer to the Company's filings with the SEC that are available at The Company cautions you that the list of important factors included in the Company's SEC filings may not contain all of the material factors that are important to you. In addition, in light of these risks and uncertainties, the matters referred to in the forward–looking statements contained in this report may not in fact occur. The Company undertakes no obligation to publicly update or revise any forward–looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Follow Avaya on Twitter, Facebook, YouTube, LinkedIn, Flickr and the Avaya Connected Blog.

Source: Avaya Newsroom

Oyu Tolgoi receives information request from Mongolian Anti-Corruption Authority

VANCOUVER, BC—(Marketwired – March 13, 2018) – Turquoise Hill Resources (NYSE: TRQ) (NASDAQ: TRQ) (TSX: TRQ) today announced that Oyu Tolgoi LLC (Oyu Tolgoi) has received an information request from the Mongolian Anti–Corruption Authority (ACA) to provide financial information relating to Oyu Tolgoi. The request relates to an investigation about possible abuse of power by authorized officials during negotiation of the 2009 Oyu Tolgoi Investment Agreement. There is no indication in the ACA information request to suggest that Oyu Tolgoi is a subject of the investigation.

Forward–looking statements

Certain statements made herein, including statements relating to matters that are not historical facts and statements of the Company's beliefs, intentions and expectations about developments, results and events which will or may occur in the future, constitute “forward–looking information” within the meaning of applicable Canadian securities legislation and “forward–looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward–looking statements and information relate to future events or future performance, reflect current expectations or beliefs regarding future events and are typically identified by words such as “anticipate”, “could”, “should”, “expect”, “seek”, “may”, “intend”, “likely”, “plan”, “estimate”, “will”, “believe” and similar expressions suggesting future outcomes or statements regarding an outlook. These include, but are not limited to, statements about anticipated business activities, planned expenditures, corporate strategies, and other statements that are not historical facts.

Forward–looking statements and information are made based upon certain assumptions and other important factors that, if untrue, could cause the actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such statements or information. There can be no assurance that such statements or information will prove to be accurate. Such statements and information are based on numerous assumptions regarding present and future business strategies, local and global economic conditions, and the environment in which the Company will operate in the future, including the price of copper, gold and silver, anticipated capital and operating costs, anticipated future production and cash flows, and the status of the Company's relationship and interaction with the Government of Mongolia on the continued development of Oyu Tolgoi and Oyu Tolgoi LLC internal governance. Certain important factors that could cause actual results, performance or achievements to differ materially from those in the forward–looking statements and information include, among others, copper; gold and silver price volatility; discrepancies between actual and estimated production, mineral reserves and resources and metallurgical recoveries; development plans for processing resources; matters relating to proposed exploration or expansion; mining operational and development risks; litigation risks; regulatory restrictions (including environmental regulatory restrictions and liability); Oyu Tolgoi LLC's ability to deliver a domestic power source for the Oyu Tolgoi project within the required contractual time frame; communications with local stakeholders and community relations; activities, actions or assessments, including tax assessments, by governmental authorities; events or circumstances (including strikes, blockages or similar events outside of the Company's control) that may affect the Company's ability to deliver its products in a timely manner; currency fluctuations; the speculative nature of mineral exploration; the global economic climate; dilution; share price volatility; competition; loss of key employees; cyber security incidents; additional funding requirements, including in respect of the development or construction of a long–term domestic power supply for the Oyu Tolgoi project; capital and operating costs, including with respect to the development of additional deposits and processing facilities; and defective title to mineral claims or property. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. All such forward–looking statements and information are based on certain assumptions and analyses made by the Company's management in light of their experience and perception of historical trends, current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. These statements, however, are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward–looking statements or information.

Readers are cautioned not to place undue reliance on forward–looking information or statements. By their nature, forward–looking statements involve numerous assumptions, inherent risks and uncertainties, both general and specific, which contribute to the possibility that the predicted outcomes will not occur. Events or circumstances could cause the Company's actual results to differ materially from those estimated or projected and expressed in, or implied by, these forward–looking statements. Important factors that could cause actual results to differ from these forward–looking statements are included in the “Risk Factors” section in the Company's Annual Information Form dated as of March 23, 2017 in respect of the year ended December 31, 2016 (the “AIF”).

Readers are further cautioned that the list of factors enumerated in the “Risk Factors” section of the AIF that may affect future results is not exhaustive. When relying on the Company's forward–looking statements and information to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events.

Savara Initiates Phase 2a Clinical Study of Molgradex for the Treatment of NTM Lung Infection

AUSTIN, TX—(Marketwired – March 13, 2018) – Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, announced today the initiation of a Phase 2a clinical study, OPTIMA, evaluating its lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte–macrophage colony–stimulating factor (GM–CSF), for the treatment of nontuberculous mycobacterial (NTM) lung infection. Molgradex is also currently being investigated in a global pivotal Phase 3 clinical study, IMPALA, for the treatment of autoimmune pulmonary alveolar proteinosis (PAP).

“The initiation of the OPTIMA study is a major milestone for Savara as we begin to explore the potential of Molgradex as a novel therapeutic approach for NTM infection,” stated Rob Neville, chief executive officer of Savara. “We believe that Molgradex may significantly improve patient outcomes by stimulating the innate immune system in the lungs, as compared with targeting bacteria directly, thereby avoiding problems of antibiotic resistance and antibiotic intolerance. We believe Molgradex will be eligible for Orphan Status as well as Qualified Infectious Disease Product Status, and if the results of the OPTIMA study meet our expectations, the product may also qualify for Breakthrough Therapy Designation.”

NTM lung infection is a considerable therapeutic challenge due to the unique ability of these bacteria to evade the normal killing mechanisms of alveolar macrophages, a type of immune cell responsible for defending against bacteria in the lungs. Scientific research in various animal models, including GM–CSF knock out mice, have demonstrated that GM–CSF plays an important role as an effector molecule activating macrophages to kill mycobacteria, with or without the simultaneous use of antibiotics. Among the various NTM species, Mycobacterium abscessus (M. abscessus) is a particularly challenging clinical problem, being one of the most resistant organisms to antibiotics.

Notably, two clinical case reports exploring the use of aerosolized GM–CSF for the treatment of M. abscessus were recently published in the European Respiratory Journal by Mark E. Wylam, M.D., Pulmonologist and Critical Care Specialist at the Mayo Clinic College of Medicine, and his coworkers. In these two cases, both involving individuals living with cystic fibrosis (CF), inhaled GM–CSF either eradicated or dramatically reduced M. abscessus infection, improved clinical outcome, and was well tolerated.

“Treatment of NTM lung infection with long multi–drug antibiotic regimens is challenging, places significant burden on patients, and yet frequently fails to eradicate the infection,” stated Rachel Thomson, M.B.B.S., Ph.D., Thoracic Physician, Associate Professor, The University of Queensland, Australia and one of the coordinating investigators on the OPTIMA study. “Based on the emerging scientific rationale and the encouraging outcomes of the first clinical cases treated with inhaled GM–CSF, I believe Molgradex represents a promising novel approach into this disease desperate for more effective treatment options.”

About the OPTIMA Phase 2a Clinical Study
OPTIMA is an open–label, non–controlled, multi–center, Phase 2a clinical study of Molgradex in 30 subjects (≥18 years of age) with persistent pulmonary NTM infection. OPTIMA will enroll subjects with chronic M. abscessus or Mycobacterium avium complex (MAC) infection, with all subjects having either antibiotic refractory infection or intolerance to standard NTM antibiotics. Subjects with CF will not be enrolled. The study will comprise a 24–week treatment period and a 12–week follow up period. Two subgroups of subjects will be recruited into the OPTIMA study. Group 1 will consist of subjects who remain sputum culture positive while currently on a multidrug NTM guideline based anti–mycobacterial regimen, which has been ongoing for at least six months prior to the baseline visit. Group 2 will consist of subjects who remain sputum culture positive, but have either stopped a multidrug NTM guideline based anti–mycobacterial regimen at least 28 days prior to screening due to lack of response or intolerance, or never started such treatment.

The primary endpoint will be sputum culture conversion, defined as at least three consecutive sputum samples without growth of NTM. Secondary endpoints include: (i) the number of subjects with sputum smear conversion to negative, defined as at least three consecutive negative acid–fast bacilli (AFB) stained sputum smears on microscopy among subjects who were smear positive at baseline, (ii) the number of subjects with durable sputum culture conversion, defined as sputum culture conversion at or before week 24 and culture still negative for growth of NTM at 12–week follow up, (iii) the number of subjects with durable sputum smear conversion, defined as sputum smear conversion at or before week 24 and AFB stained smear still negative for NTM at 12–week follow up among subjects who were smear positive at baseline, and (iv) other microbiological indicators, exercise capacities and patient reported outcomes.

About NTM Lung Infection
NTM lung infection is a rare and serious lung disorder associated with increased rates of morbidity and mortality. Nontuberculous mycobacteria are naturally–occurring organisms and NTM lung infection can occur when an individual inhales the organism from their environment and develops a slowly progressive and destructive lung disease. NTM lung infection is typically characterized by cough, fatigue and weight loss. NTM infection often becomes chronic and requires long courses of multiple antibiotics, and despite the aggressive treatment regimens, treatment failure rates are high, and recurrence of infection common. Chronic NTM lung infection can have a significant impact on quality of life. There are approximately 50,000 to 80,000 individuals affected by NTM lung infection in the U.S., the most common types involving MAC and M. abscessus. There have been few advancements in new systemic treatments for NTM lung infection. However, in a recent Phase 3 clinical study by Insmed, local delivery of an inhaled form of amikacin directly to the lung was shown to be effective in approximately one third of treatment refractory patients with pulmonary MAC infection, suggesting administration of high local concentrations of drug directly at the site of infection provides an attractive new avenue to improve clinical outcomes in this and other difficult–to–treat chronic lung infections.

About Molgradex
Molgradex is an inhaled formulation of recombinant human GM–CSF, in Phase 3 development for PAP and in Phase 2a development for nontuberculous mycobacteria, or NTM, lung infection. Molgradex is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH). Molgradex has been granted Orphan Drug Designation for the treatment of PAP in the United States and the European Union.

About Savara
Savara Inc. is an orphan lung disease company. Savara's pipeline comprises: Molgradex, an inhaled granulocyte–macrophage colony–stimulating factor, or GM–CSF, in Phase 3 development for PAP, and in Phase 2a development for NTM lung infection; and AeroVanc, a Phase 3 stage inhaled vancomycin for treatment of MRSA infection in cystic fibrosis. Savara's strategy involves expanding its pipeline of potentially best–in–class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara's management team has significant experience in orphan drug development and pulmonary medicine, in identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at (Twitter: @SavaraPharma)

Forward–Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward–looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward–looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements relating to the initiation of the OPTIMA study being a major milestone for Savara, our belief that Molgradex may significantly improve patient outcomes by stimulating the innate immune system in the lungs, as compared with targeting bacteria directly, thereby avoiding problems of antibiotic resistance and antibiotic intolerance, our belief that Molgradex will be eligible for Orphan Status as well as Qualified Infectious Disease Product Status, that Molgradex may qualify for the breakthrough therapy designation if the results of the OPTIMA study meet our expectations, the belief that based on the emerging scientific rationale and the encouraging outcomes of the first clinical cases treated with GM–CSF, Molgradex represents a promising novel approach to the treatment of NTM, that NTM is desperate for more effective treatment options, that in a recent Phase 3 clinical study by Insmed, local delivery of an inhaled form of amikacin directly to the lung was shown to be effective in approximately one third of treatment refractory patients with pulmonary MAC infection, suggesting administration of high local concentrations of drug directly at the site of infection provides an attractive new avenue to improve clinical outcomes in this and other difficult–to–treat chronic lung infections , and Savara's strategy. Savara may not actually achieve any of the matters referred to in such forward–looking statements, and you should not place undue reliance on these forward–looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward–looking statements. These forward–looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward–looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the outcome of our ongoing clinical studies for our product candidates (including our Phase 2a clinical study of Molgradex for the treatment of NTM), the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs (including our Phase 2a clinical study of Molgradex for the treatment of NTM), the ability to obtain the necessary patient enrollment for our Molgradex Phase 2a clinical study for the treatment of NTM and for our other product candidates and indications in a timely manner, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop our product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex and AeroVanc that are safe and effective for use as human therapeutics. All forward–looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8–K, Form 10–K and Form 10–Q. You are cautioned not to place undue reliance on forward–looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

Orriant Wins Prestigious Best & Brightest In Wellness(R) 2017 Elite Winner Award

SALT LAKE CITY, UT—(Marketwired – March 13, 2018) – The 5th annual Nation's Best & Brightest in Wellness® Program recently announced its 2017 winning companies. This program celebrates the accomplishment in achievements and success in empowering employees on a wellness journey. The Best & Brightest In Wellness® focuses on the value of wellness not only within business, but in the community.

The 2017 Best of the Best Wellness Provider was awarded to Orriant, a company that strives to provide increased wellness for individuals, businesses, and the community. With a retention rate of over 90%, Orriant motivates their client's employees and employees' spouses to engage in healthy lifestyles, and inspires enthusiasm, productivity, and teamwork throughout their client companies.

About Orriant

Orriant is a national corporate wellness provider with an intensive, behaviorally–focused wellness approach that consistently demonstrates measurable and meaningful health improvement. Orriant's clients are spread throughout the United States with participants living in every state. Orriant incorporates the full spectrum of well–being in every aspect of its full–service wellness program (nutritional, social, intellectual, financial, environmental, physical, occupational, and emotional well–being). Orriant offers health coaching, biometric screenings, a health–risk appraisal, workshops, chronic condition interventions, a state–of–the–art portal with apps, social–media challenges, text message reminders, fitness tracker integration and health promotion programs. Some of their offerings include Orriant TV, a platform for visual media resources, online webinars presented regularly by health professionals, health promotion campaigns, competitions and challenges where individuals or teams can compete internally or on a national scale.

Orriant's most significant differentiation is its level of actual engagement and outcomes. Orriant's clients often see more than half of the adults on their health plan calling a health coach monthly and consistently engaged in ongoing meaningful lifestyle change. As a full–service vendor, Orriant is a one–stop solution that employs a full–spectrum of strategies to bring about population behavior change, which results in improved population health.

Orriant's Results

Every one of Orriant's clients, with 3 or more years in the program, has experienced an improvement in the combined biometrics of the at–risk participants. This group represents 60% of the entire participant population on average.

Orriant's clients experience an increase in the healthy portion of their workforce with the weighted average percent increase being 23% within an average of 3 years.