On May 7, 2019 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the first quarter ended March 31, 2019 (Press release, Penumbra, MAY 7, 2019, View Source [SID1234535863]).

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Revenue of $128.4 million in the first quarter of 2019, an increase of 25.1%, or 27.2% in constant currency1, over the first quarter of 2018.
First Quarter 2019 Financial Results
Total revenue grew to $128.4 million for the first quarter of 2019 compared to $102.7 million for the first quarter of 2018, an increase of 25.1%, or 27.2% on a constant currency basis. The United States represented 64% of total revenue and international represented 36% of total revenue for the first quarter of 2019. Revenue from sales of neuro products grew to $81.5 million for the first quarter of 2019, an increase of 14.1%, or 16.5% on a constant currency basis. Revenue from sales of vascular products grew to $47.0 million for the first quarter of 2019, an increase of 50.2%, or 51.8% on a constant currency basis.

Gross profit was $83.9 million, or 65.3% of total revenue, for the first quarter of 2019, compared to $66.6 million, or 64.8% of total revenue, for the first quarter of 2018.

Total operating expenses for the first quarter of 2019 were $72.8 million, or 56.6% of total revenue. This compares to total operating expenses of $62.5 million, or 60.9% of total revenue, for the first quarter of 2018. R&D expenses were $11.7 million for the first quarter of 2019, compared to $8.0 million for the first quarter of 2018. SG&A expenses were $61.1 million for the first quarter of 2019, compared to $54.5 million for the first quarter of 2018.

Operating income for the first quarter of 2019 was $11.2 million, compared to operating income of $4.0 million for the first quarter of 2018.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the first quarter 2019 financial results after market close on Tuesday, May 7, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 6096838), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On May 7, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2019 and reaffirmed 2019 financial guidance (Press release, Jazz Pharmaceuticals, MAY 7, 2019, Jazz Pharmaceuticals Announces First Quarter 2019 Financial Results [SID1234535862]).

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"In the first quarter of 2019, we delivered strong top- and bottom-line growth and continued our efforts to bring innovative and life-changing medicines to patients, with FDA approval of Sunosi for EDS associated with narcolepsy or OSA, launch of Xyrem in pediatric narcolepsy and announcement of positive top-line results from our Phase 3 study of JZP-258," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "As the year progresses, we are continuing to invest in our business to support the successful launch of Sunosi in the U.S. and pre-launch activities in the EU, to generate data for our existing products and to fuel further advancement and diversification of our pipeline."

Financial Highlights

GAAP net income for the first quarter of 2019 was $85.2 million, or $1.47 per diluted share, compared to $46.0 million, or $0.75 per diluted share, for the first quarter of 2018.

Adjusted net income for the first quarter of 2019 was $213.2 million, or $3.67 per diluted share, compared to $182.4 million, or $2.98 per diluted share, for the first quarter of 2018. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Key Regulatory/R&D Updates

In March 2019, the company announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication and was approved with strengths of 75 mg and 150 mg for patients with narcolepsy and 37.5 mg, 75 mg, and 150 mg for patients with OSA.

In March 2019, the company announced positive top-line results from the global, double-blind, placebo-controlled, randomized-withdrawal, multi-center Phase 3 study evaluating the efficacy and safety of JZP-258 for the treatment of cataplexy and EDS in adult patients with narcolepsy. JZP-258 is a novel oxybate product candidate with a 92% reduction in sodium content compared to Xyrem.

In March 2019, positive results from DEFIFrance, an observational, multi-center, post-marketing study in adult and pediatric patients treated with defibrotide at hematopoietic stem cell transplant centers in France, were presented at the European Society for Blood and Marrow Transplant (EBMT) meeting.

Select 2019 Milestones

Programs

2019 Milestones*

Xyrem (sodium oxybate) oral solution

Launched in March for the treatment of cataplexy or EDS in pediatric narcolepsy

JZP-258

Announced positive top-line results in March from the Phase 3 narcolepsy study

Expect to submit top-line results from the Phase 3 narcolepsy study to a fall medical meeting

Pre-New Drug Application (NDA) meeting with FDA

Goal to submit NDA as early as year-end

Sunosi (solriamfetol)

FDA approval on March 20 for EDS in narcolepsy or OSA

Drug Enforcement Administration (DEA) scheduling decision by late second quarter

Initiate Sunosi launch following DEA scheduling decision

Announce new Phase 3 development program mid-year

Obtain EU approval for EDS in narcolepsy or OSA as early as year-end

Vyxeos (daunorubicin and cytarabine) liposome for injection

Presentation by Children’s Oncology Group at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (relapsed/refractory pediatric acute myeloid leukemia (AML) study data)

Potential interim combination data results from MD Anderson collaboration

Finalized protocol for Phase 1/2 study (low-dose Vyxeos in combination with venetoclax); patient enrollment is expected to begin in the second half of the year

Defitelio (defibrotide sodium) / defibrotide

Presentation of positive results from DEFIFrance study at EBMT in March

Conduct interim analysis of the Phase 3 study for prevention of hepatic veno-occlusive disease (VOD)

Complete enrollment in prevention of acute graft-vs-host disease Phase 2 study

Initiate exploratory Phase 2 study in chimeric antigen receptor t-cell therapy associated neurotoxicity

Initiate Phase 2 study in transplant-associated thrombotic microangiopathy

Asparaginase

Provide informational update on early-stage recombinant crisantaspase program later this year

CombiPlex

Continue Investigational New Drug enabling activities for one solid tumor combination and progress exploratory activities for other hematology/oncology candidates

* Milestones denoted as • have been completed; all other milestones are planned or expected in 2019.

Other Developments

In March 2019, the company launched Xyrem to treat cataplexy and EDS in pediatric narcolepsy patients following receipt of FDA approval in October 2018 after completing implementation of the Risk Evaluation and Mitigation Strategy to include pediatric patients and their caregivers.

In April 2019, the company announced the finalization of the settlement agreement with the U.S. Department of Justice (DOJ) related to the company’s support of charitable organizations that provide financial assistance to Medicare patients. In 2018, the company had announced an agreement in principle and recorded a total expense of $58.2 million related to this matter, including related interest. Under the settlement agreement, in April 2019, the company paid $57.0 million plus interest and entered into a five-year corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

Total revenues increased 14% in the first quarter of 2019 compared to the same period in 2018.

Xyrem net product sales increased 16% in the first quarter of 2019 compared to the same period in 2018.

Erwinaze/Erwinase net product sales increased 20% in the first quarter of 2019 due to an increase in product availability compared to the same period in 2018. The company continues to expect supply disruptions throughout 2019 which will cause inter-quarter variability in Erwinaze net sales.

Defitelio/defibrotide net product sales increased 18% in the first quarter of 2019 compared to the same period in 2018 due to increased use by transplant centers that treat adult and pediatric patients. VOD is an ultra-rare disease and, as a result, the company continues to expect inter-quarter variability in Defitelio net sales.

Vyxeos net product sales increased 10% in the first quarter of 2019 compared to the same period in 2018 primarily due to the rolling launch in the EU initiated in September 2018. The company continues its education and outreach initiatives and its efforts to generate data to support Vyxeos’ potential use across broader patient populations in AML and other hematological malignancies.

Operating expenses changed over the prior year period primarily due to the following:

Selling, general and administrative (SG&A) expenses on a GAAP basis decreased in the first quarter of 2019 compared to the same period in 2018 primarily due to a $57.0 million loss contingency recorded in 2018 related to the DOJ matter described above. SG&A expenses on a GAAP basis, excluding the impact of the loss contingency, and on a non-GAAP adjusted basis increased in the first quarter of 2019 compared to the same period in 2018 primarily due to higher expenses related to the planned launch of Sunosi in the U.S. and an increase in headcount and compensation-related expenses to support expansion of the business.
Research and development (R&D) expenses on a GAAP basis decreased in the first quarter of 2019 compared to the same period in 2018 primarily due to milestone payments of $11.0 million related to FDA acceptance for filing of the company’s solriamfetol NDA recorded in 2018. R&D expenses on a GAAP basis, excluding the impact of milestone payments, and on a non-GAAP adjusted basis increased in the first quarter of 2019 compared to the same period in 2018 primarily due to expenses related to the company’s pre-clinical and clinical development programs, including partner programs, regulatory activities and related headcount increases to support these efforts.
Cash Flow and Balance Sheet

As of March 31, 2019, cash, cash equivalents and investments were $832.5 million and the outstanding principal balance of the company’s long-term debt was $1.8 billion. During the first quarter of 2019, the company generated $202.3 million of cash from operations, made an upfront payment of $56.0 million to Codiak BioSciences, Inc. under a collaboration agreement and used $111.2 million to repurchase shares.

In the first quarter of 2019, the company repurchased approximately 858,000 ordinary shares under the company’s share repurchase program at an average cost of $129.66 per ordinary share. As of March 31, 2019, the remaining amount authorized for share repurchases was $267.9 million.

2019 Financial Guidance

Includes minimal net sales contribution from Sunosi in the U.S., assuming launch in mid-2019.

Excludes $6-$8 million of share-based compensation expense from estimated GAAP gross margin.

Excludes $82-$90 million of share-based compensation expense from estimated GAAP SG&A expenses.

Excludes $0-$34 million of milestone payments and $22-$27 million of share-based compensation expense from estimated GAAP R&D expenses.

Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income.

See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to Non-GAAP Adjusted 2019 Net Income Guidance" at the end of this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2019 first quarter results. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6667859.

A replay of the conference call will be available through May 14, 2019 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6667859. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On May 7, 2019 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) reported financial results for the first quarter ended March 31, 2019 (Press release, Theravance, MAY 7, 2019, View Source [SID1234535861]). Revenue for the first quarter of 2019 was $5.3 million. First quarter operating loss was $73.7 million or $61.4 million excluding share-based compensation expense. Cash, cash equivalents, and marketable securities totaled $434.1 million as of March 31, 2019.

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Rick E Winningham, Chief Executive Officer, commented: "As we continue to make progress in 2019, we remain highly focused on implementing our strategy to discover, develop and commercialize transformational medicines with the potential to address important unmet patient, payor and caregiver needs.

"The Phase 2 Crohn’s disease and Phase 2b/3 ulcerative colitis studies of TD-1473, our gut-selective pan-JAK inhibitor, are actively enrolling patients. Our registrational Phase 3 clinical program of ampreloxetine in symptomatic nOH is also underway, and we plan to present supportive five-month data from the completed Phase 2 study at scientific meetings in mid-2019. The Phase 1 study of TD-8236, our lung-selective JAK inhibitor, in healthy volunteers and asthmatic patients is ongoing and we expect to report results from the study in the third quarter of 2019.

"The YUPELRI launch is progressing following the commencement of formal sales and marketing efforts earlier this year in partnership with Mylan. In addition, sales of GSK’s TRELEGY ELLIPTA for COPD continue to accelerate supported by product approvals and launches in additional geographies, including the recent approval in Japan. We were pleased to see GSK’s recent announcement that the Phase 3 CAPTAIN study of TRELEGY ELLIPTA in patients with asthma met its primary endpoint, and GSK plans to submit the full dataset for regulatory review.

"Our strong cash position enables us to drive forward key programs in TD-1473, ampreloxetine, TD-8236, and YUPELRI, and to advance novel, organ-selective research programs toward the clinic. We intend to continue to build momentum throughout the year with a line-up of important milestones leading toward additional catalysts over the next 12 to 18 months as our late-stage trials mature, earlier-stage programs advance, and our commercial efforts gain traction," concluded Mr. Winningham.

Program Updates

TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):

Supplemental data from the Phase 1b study of TD-1473 in patients with ulcerative colitis to be shared in an oral presentation at Digestive Disease Week (DDW) in May 2019
Phase 2 DIONE induction study in Crohn’s disease and registrational Phase 2b/3 RHEA induction and maintenance study in ulcerative colitis underway
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI)):

5-month data from the Phase 2 study in patients with neurogenic orthostatic hypotension (nOH) to be presented at the International Association of Parkinsonism and Related Disorders (IAPRD) in June 2019 and selected for oral presentation at the 32nd European Neurology Congress (ENC) in July 2019
Ongoing registrational Phase 3 program in symptomatic nOH comprised of two studies:
4-week treatment study; and
4-month open label study followed by a 6-week randomized withdrawal phase to demonstrate durability of response
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):

Phase 1 data expected in the third quarter of 2019; study designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthmatic patients
Program goal in asthma is the prevention of exacerbations and the improvement of symptoms in patients uncontrolled by steroids despite compliance
TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
YUPELRI (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):

First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with COPD
Launch underway with partner Mylan; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:

First quarter 2019 net sales of $112.7 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
Phase 3 CAPTAIN study in patients with asthma met primary endpoint:
TRELEGY demonstrated statistically significant 110mL improvement in lung function compared with RELVAR/BREO
GSK plans to submit data for regulatory review once full dataset is available
Marketing authorization granted in Japan for the treatment for COPD; product now launched in 30 markets with the potential for an approval in China later this year
Notes:
1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). RELVAR/BREO ELLIPTA (the combination of fluticasone furoate and vilanterol)

First Quarter Financial Results

Revenue

Revenue from collaborative arrangements for the first quarter of 2019 was $5.3 million compared to $4.6 million in the same period in 2018. Total revenue decreased by approximately $3.0 million as compared to the first quarter of 2018. The decrease in total revenue resulted primarily from no product sales being recognized in the first quarter of 2019 following the sale of VIBATIV to Cumberland Pharmaceuticals in late 2018.

Research and Development (R&D) Expenses

R&D expenses for the first quarter of 2019 were $53.8 million, compared to $47.8 million in the same period in 2018. The increase was primarily due to an increase in external and employee-related expenses. The increase in employee-related expenses includes the impact of the reduction in force announced in the first quarter of 2019. First quarter R&D expenses included non-cash share-based compensation of $6.2 million.

Selling, General and Administrative (SG&A) Expenses

SG&A expenses for the first quarter of 2019 were $25.2 million, compared to $24.7 million in the same period in 2018. The increase was primarily due to higher collaboration and employee-related expenses. The increase in employee-related expenses includes the impact of the reduction in force announced in the first quarter of 2019. First quarter SG&A expenses included non-cash share-based compensation of $6.1 million.

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $434.1 million as of March 31, 2019.

2019 Financial Guidance

The Company’s guidance on operating loss excluding non-cash share-based compensation for the full year of 2019 remains unchanged at $210.0 million to $230.0 million. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA which the Company recognizes as non-operating income. The Company’s share of US profits and losses related to the commercialization of YUPELRI, potential future business development collaborations as well as the timing and cost of clinical studies associated with its key programs, among other factors, could impact the Company’s financial guidance.

Arbitration Against Innoviva

As noted in the Innoviva, Inc. ("Innoviva") Quarterly Report on Form 10-Q for the three months ended March 31, 20192 filed with the Securities and Exchange Commission on May 1, 2019, no distributions were made to Theravance Biopharma with respect to its 85% economic interest in Theravance Respiratory Company, LLC ("TRC LLC") for the quarter ended December 31, 2018. As a result of this unjustified withholding of cash and Innoviva’s statement to Theravance Biopharma that it intends to cause TRC LLC to withhold making further cash distributions through calendar 2019, the Company has initiated an arbitration against Innoviva and TRC LLC regarding Innoviva’s material breach of its obligations to cause TRC LLC to make contractually-required distributions to the Company from royalties paid to TRC LLC by GlaxoSmithKline and its affiliates (collectively, "GSK") related to GSK’s net sales of TRELEGY ELLIPTA.

Rick E Winningham, chairman and chief executive officer of Theravance Biopharma, commented: "Theravance Biopharma intends to aggressively enforce all aspects of its agreement with Innoviva and TRC LLC to ensure we continue receiving our stipulated 85% share of royalties linked to TRELEGY ELLIPTA net sales. We firmly believe there is no justification or legal basis for Innoviva to cause TRC LLC to withhold the Q4 2018 distributions, the 2019 distributions or any material amount of cash. We are confident that Theravance Biopharma will prevail in this dispute and retain all rights to its full portion of the TRELEGY ELLIPTA royalties paid to TRC LLC by GSK."

In connection with Theravance Biopharma’s spin-off from Innoviva in 2014, the two companies (collectively, and including Theravance Biopharma affiliates who became members, the "Members") entered into a limited liability company agreement (the "TRC LLC Agreement") that established TRC LLC. TRC LLC is jointly owned by the two companies despite being managed by Innoviva, and its purpose is to collect and disburse royalties from GSK’s sales of certain products, including TRELEGY ELLIPTA, to the Members. The terms of the Agreement plainly state that Member interests owned by Theravance Biopharma entitle it to 85% of the royalties paid to TRC LLC by GSK as a result of GSK’s net sales of TRELEGY ELLIPTA (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used in TRC LLC over the next four fiscal quarters). The TRC LLC Agreement imposes express fiduciary duties on Innoviva equal to those of directors of a for-profit corporation and those of a controlling shareholder. To ensure that Innoviva causes TRC LLC to fulfill its contractual duties to distribute royalties, and to discharge its own fiduciary duties, the TRC LLC Agreement imposes significant limitations on Innoviva’s authority as manager, including requiring Theravance Biopharma’s consent before taking actions or omitting to take actions that would reasonably be expected to have a direct or indirect material and adverse effect on the Company’s economic interest in TRC LLC or its rights, preferences, privileges or obligations.

On November 30, 2018, an affiliate of Theravance Biopharma named Triple Royalty Sub LLC (the "Issuer") closed a private placement of $250 million aggregate principal amount of non-recourse Triple PhaRMAsm 9% Fixed Rate Term notes due on or before April 15, 2033 (the "Notes"). The Notes are secured by, and the primary source of funds to make payments on the Notes is, the Issuer’s 63.75% economic interest in any future payments made by GSK to TRC LLC (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used in TRC LLC over the next four fiscal quarters).

The Notes bear an annual interest rate of 9%, with interest and principal payable quarterly beginning April 15, 2019. Through October 15, 2020, the terms of the Notes provide that to the extent there are insufficient funds to satisfy the Issuer’s scheduled quarterly interest obligations, the shortfall shall be added to the principal amount of the Notes without a default or event of default occurring. The terms of the Notes also provide that, at Theravance Biopharma’s option, the quarterly interest payment obligations can be satisfied by making a capital contribution to the Issuer, but not for more than four (4) consecutive quarterly interest payment dates or for more than six (6) quarterly interest payment dates during the term of the Notes. For the April 15, 2019 interest payment date, Theravance Biopharma R&D, Inc. (parent entity of Issuer) made a capital contribution to satisfy the interest payment obligations for that scheduled payment. If necessary, interest may be paid in-kind or Theravance Biopharma may exercise its capital contribution option in the near future while we arbitrate this dispute with Innoviva.

Rick E Winningham concluded:

"As we work to resolve this dispute in our favor, we will continue to execute on our go-forward strategy. Again, we firmly believe there is no justification or legal basis for Innoviva to cause TRC LLC to withhold any material amount of cash. We are confident that Theravance Biopharma will prevail in this dispute and retain all rights to its full portion of the TRELEGY ELLIPTA royalties paid to TRC LLC by GSK. We believe the arbitration process provided for under the Agreement will enable us to pursue and achieve a favorable resolution in a relatively timely manner."

Quinn Emanuel Urquhart & Sullivan, LLP is serving as external counsel to Theravance Biopharma in this matter.

Notes
2 As disclosed in Innoviva’s Condensed Consolidated Statement of Cash Flows and the Condensed Consolidated Statements of Stockholders’ Equity in the Form 10-Q for the three months ended March 31, 2019.

Conference Call and Live Webcast Today at 5:00 pm ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 9890346. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through June 7, 2019. An audio replay will also be available through 8:00 pm ET on May 14, 2019 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 9890346.

On May 7, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2019 financial results and provided an update on the company, including its progress in expanding the breadth and depth of the development of IPI-549 in over 500 patients (Press release, Infinity Pharmaceuticals, MAY 7, 2019, View Source [SID1234535860]). IPI-549 is a first-in-class oral immuno-oncology product candidate that targets immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. In the first quarter of 2019, Infinity entered into a clinical collaboration with Roche/Genentech moving into front-line triple negative breast cancer (TNBC) and renal cell cancer (RCC) with MARIO-3. In the first quarter of 2019, Infinity also closed the Copiktra royalty monetization for $20.9M in net proceeds and earned a $2M milestone from PellePharm, providing non-dilutive capital to fund the expanded development of IPI-549, including MARIO-3.

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"Shareholder value creation will be driven by the generation of compelling clinical data with IPI-549, funded with dilution-sensitive capital, and we are pleased to have made important progress on both of these fronts in the first quarter of this year. We continue to advance IPI-549 and remain focused on achieving our key clinical milestones for 2019," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "We are studying IPI-549 in earlier lines of therapy, new indications and novel, potentially transformative immuno-oncology combinations in 2019."

Anticipated Milestones in 2019: Expanding Depth and Breadth of IPI-549 Development

2Q2019

Initiate MARIO-275, a Phase 2 study of IPI-549 in combination with Opdivo, in second-line immuno-oncology (I/O) naïve urothelial cancer patients, in collaboration with BMS
2H2019

Initiate MARIO-3, a Phase 2 study of novel triple combination front-line therapy, in clinical collaboration with Roche/Genentech:
IPI-549 in combination with Tecentriq and Abraxane in TNBC
IPI-549 in combination with Tecentriq and Avastin in RCC
Complete enrollment of MARIO-1 combination expansion cohorts including:
Augmented melanoma expansion cohort (n=40)
TNBC expansion cohort (n=29)
Advance into novel triple combination therapies beyond checkpoint inhibitors: initiate triple therapy (IPI-549+AB928+Abraxane) in previously treated advanced TNBC in collaboration with Arcus Biosciences
First Quarter 2019 Financial Results

At March 31, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $70.5 million, compared to $58.6 million at December 31, 2018.
Infinity recognized the $30 million gross proceeds from the Copiktra royalty monetization as a liability, net of transaction costs, as of March 31, 2019. We are amortizing the liability to non-cash interest expense, and we will continue to recognize the royalty revenue that Verastem pays to HealthCare Royalty Partners III, L.P. (HCR) as non-cash royalty revenue. We shared 25% of the proceeds, net of expenses, under the HCR agreement with Takeda. In addition, we will pay to Takeda 25% of royalties that, but for the HCR agreement, would have been payable to us by Verastem during the term of the HCR agreement.
Revenue during the first quarter of 2019 was $2.1 million, which primarily relates to the achievement of a $2.0 million milestone from PellePharm for the initiation of a Phase 3 study investigating patidegib (a hedgehog pathway inhibitor) in patients with Gorlin Syndrome. We did not have any revenue for the same period in 2018.
R&D expense for the first quarter of 2019 was $5.8 million, compared to $5.9 million for the same period in 2018.
General and administrative expense was $3.4 million for the first quarter 2019, compared to $3.6 million for the same period in 2018.
Royalty expense for the first quarter of 2019 was $6.8 million, which primarily relates to our payment to Takeda in relation to the monetization of Copiktra royalties.
Net loss for the first quarter of 2019 was $13.7 million, or a basic and diluted loss per common share of $0.24, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.18 for the same period in 2018.
2019 Updated Financial Guidance

Net Loss: Infinity expects net loss for 2019 to range from $40 million to $50 million including the Copiktra royalty monetization.
Cash and Investments: Infinity expects to end 2019 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million including the Copiktra royalty monetization.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2H 2020. Infinity’s financial guidance excludes additional funding or business development activities and excludes the potential monetization of future milestones and/or royalties payments from PellePharm, a private company, to whom Infinity licensed patidegib in 2013.
Conference Call Information

Infinity will host a conference call today, May 7, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 5779562. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Infinity and IPI-549

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab) in approximately 220 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. Infinity intends to initiate MARIO-275, a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients in 2Q19, as well as to initiate MARIO-3, the first IPI-549 combination study in front-line advanced cancer patients in 2H19. MARIO-3 will evaluate IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. With the addition of MARIO-275 and MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve and front-line settings in a total of ~500 patients. For more information on Infinity, please refer to Infinity’s website at www.infi.com.

On May 7, 2019 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported financial and operational results for the quarter ending March 31, 2019 (Press release, Cytosorbents, MAY 7, 2019, View Source [SID1234535859]).

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First Quarter 2019 Financial Results:

Total revenue for Q1 2019 was $5.2 million, including both product sales and grant income, compared to $4.9 million in Q1 2018
Product sales for Q1 2019 were $4.6 million, compared to $4.4 million for Q1 2018. Adjusted first quarter 2019 product sales would have been approximately $4.9 million, after reflecting changes in the Euro to dollar exchange rate between periods
Direct sales continue to expand and achieved new highs, reflecting 18% quarterly growth year-over-year, and 4% sequential growth compared to Q4 2018. Results do not yet materially reflect additions to the sales infrastructure, and new direct territories added in Q1 2019
Distributor sales were affected by anticipated short-term issues from three distributors. As disclosed previously, Fresenius Medical Care is transitioning to new exclusive sales territories (e.g. Mexico, South Korea, Czech Republic) while maintaining France and Finland, and did not order in Q1 2019 as it sells through non-transferable European product inventory. Meanwhile, two other distributors temporarily paused from ordering to rebalance inventory, but have strong and growing end user demand for CytoSorb. We expect these issues to resolve before or during the second half of 2019
Product gross margins for Q1 2019 and Q1 2018 were 74%
Strong cash position of $19.6 million at March 31, 2019
First Quarter 2019 Operational Highlights:

Exceeded 61,000 cumulative CytoSorb treatments delivered, an increase from 40,000 a year ago
Expanded partnership with Fresenius Medical Care to include an expansion of its exclusive distribution agreement to sell CytoSorb in Mexico, South Korea, and the Czech Republic, while maintaining France and Finland
Following a review of the first 50 patients, the independent Data Safety Monitoring Board (DSMB) and Scientific Advisory Board (SAB) recommended continuation of the German government-funded REMOVE endocarditis trial. The trial has now enrolled 180 patients, or nearly 75% of the targeted 250 patients, at 15 active sites
The REFRESH 2-AKI company-sponsored pivotal trial has increased enrollment to 79 patients at 23 clinical trial sites, and has attained approximately 20% of a targeted 400 patient enrollment
HemoDefend-RBC tooling delays have been resolved, parts have been manufactured, and clinical trial devices are being assembled. Meanwhile, an FDA investigational device exemption (IDE) submission is targeted for the second half of this year. A contract research organization (CRO) has been selected to manage the pivotal trial and has begun clinical site negotiations
Hosted the 6th International CytoSorb Users Meeting in Brussels, Belgium, in connection with the 39th International Symposium of Intensive Care and Emergency Medicine (ISICEM)
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents Corporation stated, "Q2 2019 product sales are expected to return to our historical growth trajectory, and are anticipated to be the highest quarterly product sales reported in our history. In addition, we continue to forecast strong revenue growth for all of 2019, despite a slow start in Q1, based on numerous growth opportunities we see."

Dr. Chan continued, "Specifically, we anticipate CytoSorb direct sales will continue strengthening and accelerate into the second half of this year, driven by organic growth, our investments in a larger direct sales team – particularly in Germany, reimbursement, contributions from new direct territories including Poland, Netherlands, and Scandinavia, new clinical data and applications, and other catalysts."

"In addition, we believe the factors that impacted Q1 indirect sales are short-term and specific to the three distributors as described above. For example, Fresenius (FMC) is selling through its European inventory of CytoSorb in France and Finland, while it begins sales in the Czech Republic and pursues registration of CytoSorb in both Mexico and South Korea. It is expected that FMC will order new CytoSorb devices for these countries once registration is achieved. We are encouraged that each of these customers has increased their commitment to selling CytoSorb, including aggressively pursuing new indications, increasing resource allocation, and working closely with our company to drive success. Importantly, we see end-user demand increasing in their territories, based on the excellent foundation they have established. Over the next several quarters, we expect a resumption of ordering from all three groups. Of special note, we do not require these orders to achieve our guidance for Q2 2019." Dr. Chan concluded, "Lastly, we reiterate our guidance on expanding our blended product gross margins to 80% on a quarterly basis this year."

"Please join us on our earnings conference call today, details for which are below."

Conference Call Details:
Date: Tuesday, May 7, 2019
Time: 4:45 PM Eastern Time
Participant Dial-In: 877-451-6152
Conference ID: 13690052
Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

Results of Operations

Comparison for the three months ended March 31, 2019 and 2018:

Revenues:

Revenue from product sales was approximately $4,577,000 in the three months ended March 31, 2019, as compared to approximately $4,433,000 in the three months ended March 31, 2018 an increase of approximately $144,000, or 3%. This increase was driven by an increase in direct sales of approximately $624,000 resulting from sales to both new customers and repeat orders from existing customers, offset by a decrease in distributor sales of approximately $480,000. In addition, first quarter 2019 sales were negatively impacted by $363,000 as a result of the decrease in the average exchange rate of the Euro. For the three months ended March 31, 2019, the average exchange rate of the Euro to the U.S. dollar was $1.14 as compared to an average exchange rate of $1.23 for the three months ended March 31, 2018.

Grant income was approximately $615,000 for the three months ended March 31, 2019 as compared to approximately $491,000 for the three months ended March 31, 2018, an increase of approximately $124,000 or 25%. This increase was a result of timing of certain grant revenue and income recognized from a new grant.

Total revenues were approximately $5,192,000 for the three months ended March 31, 2019, as compared to total revenues of approximately $4,925,000 for the three months ended March 31, 2018, an increase of approximately $267,000, or 5%.

Cost of Revenues:

For the three months ended March 31, 2019 and 2018, cost of revenue was approximately $1,739,000 and $1,568,000, respectively, an increase of approximately $171,000. Product cost of revenues increased approximately $52,000 during the three months ended March 31, 2019 as compared to the three months ended March 31, 2018 due to increased sales. Product gross margins were approximately 74% for each of the three months ended March 31, 2019 and 2018.

Research and Development Expenses:

For the three months ended March 31, 2019, research and development expenses were approximately $2,419,000 as compared to research and development expenses of approximately $1,725,000 for the three months ended March 31, 2018. The increase of approximately $694,000 was due to an increase in clinical trial costs of approximately $888,000, which is primarily related to our REFRESH 2-AKI trial and an increase in non-clinical research and development salary related costs of approximately $9,000. These increases were offset by an increase in direct labor and other costs being deployed toward grant-funded activities of approximately $118,000, which had the effect of decreasing the amount of our non-reimbursable research and development costs, a decrease in new product development costs of approximately $67,000 and a decrease of other non-clinical research and development costs of approximately $18,000.

Legal, Financial and Other Consulting Expense:

Legal, financial and other consulting expenses were approximately $562,000 for the three months ended March 31, 2019, as compared to approximately $416,000 for the three months ended March 31, 2018. The increase of approximately $146,000 was due to an increase in legal fees of approximately $167,000 related to patent matters and certain corporate initiatives and an increase in consulting fees of approximately $18,000. These increases were offset by a decrease in employment agency fees of approximately $36,000 and a decrease in accounting fees of approximately $3,000.

Selling, General and Administrative Expense:

Selling, general and administrative expenses were approximately $4,758,000 for the three months ended March 31, 2019, as compared to approximately $4,317,000 for the three months ending March 31, 2018. The increase of $441,000 was due to an increase in salaries, commissions and related costs of approximately $424,000, an increase in travel and entertainment and other costs of approximately $142,000, additional sales and marketing costs, which include advertising and conferences of approximately $88,000, an increase in royalty expenses of approximately $7,000 due to the increase in product sales, an increase in rent expense of approximately $11,000 related to the expansion of manufacturing and office facilities and an increase in other general and administrative cost increases of approximately $21,000. These increases were offset by a decrease in non-cash stock compensation of approximately $252,000.

Interest Expense, net:

For the three months ended March 31, 2019, interest expense was approximately $205,000, as compared to interest expense of approximately $239,000 for the three months ended March 31, 2018. This decrease in interest expense of approximately $34,000 is due to an increase in interest earned on our cash balances during the three months ended March 31, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the three months ended March 31, 2019, the loss on foreign currency transactions was approximately $(393,000) as compared to a gain of approximately $358,000 for the three months ended March 31, 2018. The 2019 loss is directly related to the decrease in the exchange rate of the Euro to the U.S. dollar at March 31, 2019 as compared to December 31, 2018. The exchange rate of the Euro to the U.S. dollar was $1.12 per Euro at March 31, 2019, as compared to $1.15 per Euro at December 31, 2018. The 2018 gain is directly related to the increase in the exchange rate of the Euro at March 31, 2018 as compared to December 31, 2017. The exchange rate of the Euro to the U.S. dollar was $1.23 per Euro at March 31, 2017 as compared to $1.07 per Euro at December 31, 2017.

History of Operating Losses:

We have experienced substantial operating losses since inception. As of March 31, 2019, we had an accumulated deficit of approximately $174,408,000, which included losses of approximately $4,884,000 and $2,982,000 for the three-month periods ended March 31, 2019 and 2018, respectively. Historically, losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies, and general and administrative expenses.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. At March 31, 2019, we had current assets of approximately $24,828,000 including cash on hand of approximately $19,647,000, and current liabilities of approximately $6,711,000.

We believe that we have sufficient cash to fund our operations into 2020.

2019 Second Quarter Revenue Guidance

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, Q2 2019 product sales are expected to return to our historical growth trajectory, and are anticipated to be the highest quarterly product sales reported in our history.

For additional information, please see the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on March 7, 2019 on View Source