On May 5, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported financial results for the first quarter of 2016 (Press release, Merck & Co, MAY 5, 2016, View Source [SID:1234512007]).

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"Our first quarter’s performance sets us on a good course for the year," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "We remain focused on advancing our pipeline and driving the commercial success of our key launches and inline medicines and vaccines."

Financial Summary

First Quarter
$ in millions, except EPS amounts 2016 2015
Sales $9,312 $9,425
GAAP EPS
0.40 0.33
Non-GAAP EPS that excludes items listed below1
0.89 0.85
GAAP net income2
1,125 953
Non-GAAP net income that excludes items listed below1,2
2,492 2,426
Non-GAAP (generally accepted accounting principles) earnings per share (EPS) of $0.89 for the first quarter exclude acquisition- and divestiture-related costs and restructuring costs.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow.


$ in millions, except EPS amounts First Quarter
2016 2015
EPS
GAAP EPS $0.40 $0.33
Difference3
0.49 0.52
Non-GAAP EPS that excludes items listed below1
$0.89 $0.85

Net Income
GAAP net income2 $1,125 $953
Difference 1,367 1,473
Non-GAAP net income that excludes items listed below1,2 $2,492 $2,426

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs4
$1,423 $1,526
Restructuring costs 196 225
Net decrease (increase) in income before taxes 1,619 1,751
Estimated income tax (benefit) expense (252) (278)
Decrease (increase) in net income $1,367 $1,473

Additional Executive Commentary

"Business development is a top priority, and we are actively pursuing the best external science through licensing or bolt-on acquisitions to bolster our pipeline and grow our company," said Frazier.

"The Global Human Health business performed well in the first quarter. The JANUVIA franchise demonstrated strong growth, and we remain pleased with the ongoing launch of KEYTRUDA in markets around the world," said Adam Schechter, president, Global Human Health. "Additionally, we are already seeing positive signs in the launch of ZEPATIER in the United States."

"Merck Research Laboratories advanced several clinical development programs in the first quarter of 2016. We continued to accelerate the development of KEYTRUDA with an additional supplemental filing in head and neck cancer, and by securing a fourth Breakthrough Therapy Designation in classical Hodgkin lymphoma," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.

"We demonstrated strong performance with a leveraged P&L, growing sales and EPS, excluding the impact of foreign exchange. We benefited from the contribution of new product launches, while continuing to sustain growth in our key franchises and driving operational improvements across the company," said Robert Davis, chief financial officer.

Select Business Highlights

Worldwide sales were $9.3 billion for the first quarter of 2016, a decrease of 1 percent compared with the first quarter of 2015, including a 4 percent negative impact from foreign exchange.

The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of Animal Health products.


$ in millions First Quarter Change Change
Ex-Exchange
2016 2015
Total Sales $9,312 $9,425 -1% 3%
Pharmaceutical 8,104 8,266 -2% 2%
JANUVIA / JANUMET 1,412 1,393 1% 4%
ZETIA / VYTORIN 889 887 0% 4%
GARDASIL / GARDASIL 9 378 359 5% 7%
PROQUAD, M-M-R II and VARIVAX
357 348 3% 4%
REMICADE 349 501 -30% -26%
ISENTRESS 340 385 -12% -8%
CUBICIN 292 187* 56%* 57%*
KEYTRUDA 249 83 ** **
SINGULAIR 237 245 -3% -1%
NASONEX 229 289 -21% -19%
Animal Health 829 829 0% 9%
Other Revenues 379 330 15% 23%
*First quarter of 2015 reflects approximately two months of sales following the acquisition of Cubist Pharmaceuticals, Inc. (Cubist) by Merck on Jan. 21, 2015. Percentages reflect comparison to full quarter of sales in 2016.
**≥ 100%

Commercial and Pipeline Highlights

During the first quarter of 2016, the company continued to focus on advancing its pipeline, and achieved regulatory and clinical milestones for multiple products in its portfolio.

Merck advanced its development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy for the treatment of metastatic non-small cell lung cancer (NSCLC) in previously treated patients whose tumors express PD-L1, as well as advanced melanoma.
The U.S. Food and Drug Administration (FDA) accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The FDA granted Priority Review with a PDUFA action date of Aug. 9, 2016; the sBLA will be reviewed under the FDA’s Accelerated Approval program.
KEYTRUDA received Breakthrough Therapy Designation from the FDA for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma. It is the fourth Breakthrough Therapy Designation granted for KEYTRUDA.
The FDA also accepted for review a sBLA for KEYTRUDA to include data from the pivotal KEYNOTE-010 study in which KEYTRUDA showed superior overall survival compared to chemotherapy in patients with previously treated advanced NSCLC whose tumors express PD-L1. In accordance with the accelerated approval process, the data from KEYNOTE-010 was intended to serve as the confirmatory trial for receiving full approval, establishing the clinical benefit by demonstrating improved survival over standard chemotherapy.
The KEYTRUDA clinical development program includes patients with more than 30 tumor types in more than 250 clinical trials, including more than 100 trials that combine KEYTRUDA with other cancer treatments. Registration-enabling trials of KEYTRUDA are currently enrolling patients with melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, ovarian cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, nasopharyngeal cancer, and other tumors, with further trials in planning for other cancers.
The FDA approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin.
The FDA accepted for review the Biologics License Application (BLA) for MK-8237, the company’s investigational house dust mite sublingual allergy immunotherapy tablet.
The Antimicrobial Drugs Advisory Committee of the FDA has scheduled a meeting on June 9, 2016 to discuss the BLA for ZINPLAVA (bezlotoxumab), an investigational antitoxin for the prevention of Clostridium difficile (C. difficile) infection recurrence, which was accepted by the FDA for Priority Review with a PDUFA action date of July 23, 2016.
Pharmaceutical Revenue Performance

First-quarter pharmaceutical sales declined 2 percent to $8.1 billion, including a 4 percent negative impact from foreign exchange. Excluding the impact of exchange, growth reflects higher sales in oncology, hospital acute care and diabetes. Growth in oncology was driven by higher sales of KEYTRUDA as the company continues to launch the product with new indications and in new markets. Growth in hospital acute care was driven by sales of the Cubist portfolio and sales growth of certain inline brands. Pharmaceutical sales also reflect an increase in the diabetes franchise of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCl), medicines that help lower blood sugar in adults with type 2 diabetes, driven by strong growth in the United States and Europe, partially offset by lower sales in emerging markets.

First-quarter pharmaceutical sales reflect a decrease in REMICADE (infliximab), a treatment for inflammatory diseases, due to the accelerating impact of biosimilar competition in the company’s marketing territories in Europe. Pharmaceutical sales also reflect declines in NASONEX (mometasone furoate monohydrate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, and ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster. Pharmaceutical sales were unfavorably affected in the first quarter of 2016 by the company’s reduced operations in Venezuela.

A generic version of NASONEX became available in the United States in March 2016; as a result, the company anticipates significant losses of future NASONEX sales. Additionally, in June 2016 the company will lose U.S. patent protection for CUBICIN (daptomycin for injection), an I.V. antibiotic, and significant losses of CUBICIN sales are expected to occur thereafter.

Animal Health Revenue Performance

Animal Health sales, which totaled $829 million for the first quarter of 2016, were in line with sales from the first quarter of 2015. Excluding the impact of foreign exchange, Animal Health sales grew 9 percent, primarily driven by BRAVECTO (fluralaner), a chewable tablet that kills fleas and ticks in dogs for up to 12 weeks.

First-Quarter 2016 Expense and Other Information

The tables that follow present selected expense information.


$ in millions Included in expenses for the period
Acquisition-
and
First Quarter Divestiture- Restructuring
2016 GAAP
Related Costs4
Costs
Non-GAAP1
Materials and production $3,572 $1,386 $47 $2,139
Marketing and administrative 2,318 2 3 2,313
Research and development 1,659 35 55 1,569
Restructuring costs 91 – 91 –
First Quarter
2015

Materials and production $3,569 $1,250 $105 $2,214
Marketing and administrative 2,601 227 36 2,338
Research and development 1,737 63 2 1,672
Restructuring costs 82 – 82 –

The gross margin was 61.6 percent for the first quarter of 2016 compared to 62.1 percent for the first quarter of 2015, reflecting 15.4 and 14.4 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above.

Research and development (R&D) expenses, on a non-GAAP basis, were $1.6 billion in the first quarter of 2016, a 6 percent decrease compared to the first quarter of 2015, primarily driven by lower licensing expenses.

Financial Outlook

Merck continues to expect its full-year 2016 GAAP EPS to be between $1.96 and $2.23. The company has narrowed and raised its full-year 2016 non-GAAP EPS to be between $3.65 and $3.77, including an approximately 2 percent negative impact from foreign exchange at mid-April exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs. The change in the non-GAAP EPS range reflects recent favorability in foreign exchange rates, partially offset by the earlier than expected entry of a generic version of NASONEX in the United States.

At mid-April exchange rates, Merck now anticipates full-year 2016 revenues to be between $39.0 billion and $40.2 billion, including an approximately 2 percent negative impact from foreign exchange.

In addition, the company continues to expect full-year 2016 non-GAAP marketing and administrative expenses to be below 2015 levels and R&D expenses to be modestly above 2015 levels.

The company continues to anticipate its full-year 2016 non-GAAP tax rate will be in the range of 21.5 to 22.5 percent, including a 2016 R&D tax credit.

A reconciliation of anticipated 2016 EPS, as reported in accordance with GAAP to non-GAAP EPS that excludes certain items, is provided in the table below.


Full Year
$ in millions, except EPS amounts 2016
GAAP EPS $1.96 to $2.23
Difference3 1.69 to 1.54
Non-GAAP EPS that excludes items listed below $3.65 to $3.77

Acquisition- and divestiture-related costs $4,700 to $4,400
Restructuring costs 900 to 700
Net decrease (increase) in income before taxes 5,600 to 5,100
Estimated income tax (benefit) expense (900) to (805)
Decrease (increase) in net income $4,700 to $4,295
Total Employees

As of March 31, 2016, Merck had approximately 68,000 employees worldwide.

On May 05, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate update and reported financial results for the first quarter ending March 31, 2016 (Press release, Five Prime Therapeutics, MAY 5, 2016, View Source [SID:1234511997]).

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"We are pleased with the progress in our clinical programs during the first quarter of this year," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We reported encouraging data for FPA144, including preliminary Phase 1 data demonstrating several partial responses in patients with FGFR2b+ tumors, as well as pre-clinical findings that suggest that FPA144 drives innate and adaptive responses to help drive an immune cascade in a patient’s tumor. We continue Phase 1a dose exploration in our trial combining FPA008 with OPDIVO (nivolumab) in multiple tumor types, and are on track to begin the Phase 1b dose expansion portion during the second half of 2016. In addition, we recently began screening patients and expect to begin patient dosing soon in the Phase 2 portion of our clinical trial of FPA008 in patients with pigmented villonodular synovitis (PVNS), a rare indication for which we received orphan drug designation in January."

Business Highlights and Recent Developments

Clinical Development:

FPA008: an investigational antibody that inhibits CSF1R and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Five Prime and Bristol-Myers Squibb (BMS) have an exclusive worldwide collaboration agreement for the development and commercialization of FPA008.
Phase 1a/1b FPA008/OPDIVO Combination Trial Advances and Evolves. Five Prime continued dose exploration in the Phase 1a/1b clinical trial evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of FPA008 with OPDIVO, BMS’s PD-1 immune checkpoint inhibitor. The trial is currently expected to enroll approximately 280 patients and remains on track to move into Phase 1b during the second half of 2016.
Phase 1b has been modified to now explore combination therapy in the following tumor types: non-small cell lung, head and neck, pancreatic, renal, ovarian and glioblastoma.
Five Prime increased the size of the Phase 1a portion of the study to enroll more patients at the highest selected FPA008 dose as monotherapy, and at the highest selected FPA008 dose in combination therapy with OPDIVO. The new 1a expansion, which is planned to be done in parallel with Phase 1b, will allow Five Prime to more rapidly and efficiently examine the safety and activity of both monotherapy and combination in patients with tumor types not currently addressed in the Phase 1b cohorts.
Advanced Clinical Trial of FPA008 in Patients with PVNS.
Five Prime recently began patient screening for the Phase 2 portion of the ongoing Phase 1/2 clinical trial of FPA008 in PVNS, a CSF-1 receptor-driven tumor. Patient dosing is expected to begin soon in the Phase 2 portion of the trial, which will evaluate clinical measures, including response rate, pain and range of motion in approximately 30 PVNS patients. The U.S. Food and Drug Administration (FDA) granted FPA008 orphan drug designation for the treatment of PVNS in January 2016. Five Prime also recently collaborated with an academic group to complete an epidemiology study, which suggests the U.S. prevalence for diffuse PVNS patients may be as high as 25,000 patients, and expects to submit the full manuscript for future publication.
FPA144: an isoform-selective antibody in development as a targeted therapy for tumors that over-express FGFR2b. FPA144 has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity, or ADCC, to increase direct tumor cell killing by recruiting natural killer (NK) cells.
Presented preliminary data from the dose escalation portion of the Phase 1 trial of FPA144 monotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January:
Two partial responses in six gastric cancer patients with IHC 3+ FGFR2b-positive gastric cancer;
A partial response in a patient whose bladder cancer overexpressed FGFR2b; and
FPA144 was well tolerated with the most common treatment-emergent adverse events being Grades 1 or 2 and self-limiting.
Clinical data from the Phase 1 clinical trial will be updated in an oral presentation during the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2016.
Amended the Phase 1 trial to add new cohorts. The trial will include additional cohorts to assess the activity and safety of FPA144 in gastric cancer with low or moderate levels of FGFR2b expression, as well as in other tumor types that express FGFR2b.
Presented preclinical data for FPA144 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. FPA144 was featured in two presentations at the AACR (Free AACR Whitepaper) meeting in April 2016. Five Prime demonstrated that FPA144’s enhanced ADCC mechanism drives innate and adaptive immune responses in the tumor microenvironment, recruiting NK and T cells into the tumor. Additionally, FPA144 produced an additive effect on tumor growth inhibition when combined with PD-1 blockade. These pre-clinical findings suggest the therapeutic potential for a combination of FPA144 with a checkpoint inhibitor in gastric cancer.
Continued enrollment of mesothelioma patients in Phase 1b trial of FP-1039, an FGF Ligand Trap. In January 2016, GSK and Five Prime agreed to stop enrollment in the squamous non-small cell lung cancer (sqNSCLC) patient arms given the change in sqNSCLC treatment paradigms, but the companies agreed that GSK would continue enrolling mesothelioma patients based on encouraging preliminary data from that arm of the trial. In March 2016, GSK provided a 180-day notice of termination of the FP-1039 license and collaboration agreement. Five Prime is working with GSK to complete the mesothelioma study and to transfer the asset and program back to Five Prime. Mesothelioma could represent a potentially attractive market opportunity for Five Prime, and decisions on the development of FP-1039 in mesothelioma will be based on the quality and durability of responses in this trial, as well as other considerations, such as drug supply and manufacturing. GSK has submitted mesothelioma data for presentation at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting.
Preclinical Research and Development:

Progressed Internal Immuno-Oncology Research Programs. Five Prime continues to advance multiple candidates into preclinical development and expects to have two programs entering pre-IND studies before the end of 2016. The Company anticipates filing one IND by the end of 2017 and to have preclinical assets sufficient to keep the pace of one IND per year for the foreseeable future.

Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $482.0 million on March 31, 2016, compared to $517.5 million on December 31, 2015. The decrease in first quarter 2016 cash was primarily attributable to cash used in operations to advance the FPA144 clinical trial, preclinical programs and tax payments.
Revenue. Collaboration revenue for the first quarter of 2016 increased by $2.2 million to $6.5 million from $4.3 million in the first quarter of 2015. This was primarily due to revenue recognized under the 2015 FPA008 license and collaboration agreement with BMS, under which Five Prime is reimbursed for the immuno-oncology trial expenses.
R&D Expenses. Research and development expenses for the first quarter of 2016 increased by $7.1 million, or 63%, to $18.3 million from $11.2 million in the first quarter of 2015. This increase was primarily related to advancing the FPA144, preclinical and immuno-oncology research programs.
G&A Expenses. General and administrative expenses for the first quarter of 2016 increased by $4.4 million, or 105%, to $8.6 million from $4.2 million in the first quarter of 2015. This increase was primarily due to increases in stock-based compensation expenses.
Net Loss. Net loss for the first quarter of 2016 was $13.0 million, or $0.49 per basic and diluted share, compared to a net loss of $11.0 million, or $0.44 per basic and diluted share, for the first quarter of 2015.
Shares Outstanding. Total shares outstanding were 28.2 million as of April 29, 2016.
Cash Guidance. Five Prime continues to expect full-year 2016 net cash used in operating activities to be less than $120 million, comprising less than $90 million used in operations and less than $30 million used for tax payments. The company estimates ending 2016 with approximately $400 million in cash, cash equivalents and marketable securities.

On May 5, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported a research collaboration with Affilogic, a privately held biotechnology company developing affinity proteins called Nanofitins that selectively bind and interact with identified targets (Press release, BIND Therapeutics, MAY 5, 2016, View Source [SID:1234511973]).

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Under terms of the collaboration, BIND will utilize Nanofitins as targeting ligand components for ACCURINS designed to bind immuno-oncology targets. Upon achievement of proof-of-concept, BIND anticipates expanding the collaboration to develop ACCURINS that incorporate unique combinations of immuno-oncology targeting ligands and new classes of payloads, including oligonucleotides and molecularly targeted therapies.

"Targeting ligand collaborations are an important part of our strategy to develop innovative medicines and this collaboration provides us with access to targeting ligands that are key modulators of anti-tumor immunity," said Jonathan Yingling, Ph.D., chief scientific officer, BIND Therapeutics. "The modular nature of our platform, including the ability to utilize targeting ligands that elicit a biological response and enhance disease tissue accumulation, will potentially allow us to develop ACCURINS that cause tumor cell death and/or modulate the tumor microenvironment as a way to maximize clinical benefit for patients."

ACCURINS are polymeric nanoparticles that encapsulate and control the release of therapeutic payloads with diverse physical and chemical properties, including highly charged payloads such as oligonucleotides and molecularly targeted therapies that have previously been difficult to formulate in a nanoparticle. Additionally, the surface of ACCURINS can be functionalized with a variety of biologically active ligands, potentially with multiple types of ligands on the same particle. BIND’s collaboration with Affilogic is intended to investigate the use of Nanofitins protein ligands that bind to important immune regulators.

"We are excited about our collaboration with BIND Therapeutics and believe our Nanofitin targeting ligands can play an important role in BIND’s innovative medicine strategy," said Olivier Kitten, chief executive officer, AFFILOGIC. "BIND’s ACCURINS platform has proven very effective at encapsulating and controlling the release kinetics of a wide variety of therapeutic payloads. When combined with our ability to specifically tailor Nanofitins to target important immune-oncology checkpoints, we believe this collaboration could lead to the discovery and development of truly innovative therapeutics."

This early research collaboration is not expected to have a material financial impact on BIND Therapeutics. Additional terms of the collaboration have not been disclosed.

About ACCURINS
ACCURINS are proprietary polymeric nanoparticles that are engineered to target specific cells and tissues in the body at sites of disease. ACCURINS have the potential to achieve therapeutic outcomes not currently possible with conventional treatment modalities. We are developing ACCURINS with three different therapeutic objectives, both through internal research programs and with collaborators:

Innovative medicines: Designing new therapeutic approaches by combining novel targeting methods and new classes of therapeutic payloads.
Enabling potent pathway inhibitors: Enabling greater inhibition of important cellular pathways where that level of inhibition has been unachievable due to off target toxicity.
Differentiated profile with approved drugs: Improving upon safety and efficacy with previously approved chemotherapeutic agents.
ACCURINS can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables ACCURINS to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

About Nanofitins
Nanofitins are small affinity proteins that can be easily conjugated to other moieties (small molecule, biologics, nanoparticles) by genetic fusion or standard chemistry (regioselective conjugation). This enables to consider a Nanofitin not only as a neutralizing agent but also as a vector to increase target-specificity and enable cellular uptake. Nanofitins demonstrate many small molecule-like attributes such as a very small size (20 times smaller than a monoclonal antibody), an extreme robustness and a better tissue penetration. Deriving from a naturally hyperstable scaffold, Nanofitins are resistant to temperature and pH, are spontaneously refolding and stable to proteases. Nanofitins are produced by simple, scaleable, GMP- compliant bacterial fermentation at very attractive costs or by chemical synthesis.

Affilogic designs and develops Nanofitins through early-stage collaborations, as well as a proprietary portfolio.