On May 6, 2016 Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, reported financial results for the first quarter ended March 31, 2016 (Filing, Q1, Mast Therapeutics, 2012, MAY 6, 2016, View Source [SID:1234512073]).

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"The first quarter of 2016 was a productive one for Mast. Not only did we complete enrollment in our Phase 3 EPIC study of vepoloxamer in sickle cell disease, but also we announced positive data from a Phase 2a study of AIR001 in patients with heart failure with preserved ejection fraction conducted at Mayo Clinic, and the selection of AIR001 for a double-blind, placebo-controlled Phase 2 study in approximately 100 patients with HFpEF to be conducted at premier U.S. clinical centers that make up the HFN," stated Brian M. Culley, Chief Executive Officer.

"With 388 patients, the EPIC study was the largest placebo-controlled study in sickle cell disease ever concluded and should provide many insights into the activity of vepoloxamer in this indication. Importantly, vepoloxamer has the potential to become the first and only approved therapy for shortening the duration of a sickle cell vaso-occlusive crisis and we are working diligently toward generating top-line results, which we expect to announce this quarter," continued Mr. Culley. "Meanwhile, we are advancing our two heart failure programs. Our 150-patient Phase 2 study of vepoloxamer in chronic heart failure is ongoing, with ten study sites now open, and the HFN’s 100-patient Phase 2 study of AIR001 in HFpEF is expected to begin in the third quarter of 2016."

First Quarter 2016 Operating Results

The Company’s net loss for the first quarter of 2016 was $11.2 million, or $0.06 per share (basic and diluted), compared to a net loss of $9.6 million, or $0.06 per share (basic and diluted), for the same period in 2015.

Research and development expenses for the first quarter of 2016 were $7.9 million, an increase of $1.9 million, or 30%, compared to $6.0 million for the same period in 2015. The increase was due mainly to increases of $0.9 million in external nonclinical study fees and expenses, $0.5 million in external clinical study fees and expenses, and $0.3 million in personnel expenses.

The increase in external nonclinical study fees and expenses was due primarily to increased costs related to preparation for a new drug application for vepoloxamer ($0.5 million) and research-related manufacturing for vepoloxamer ($0.5 million), offset by a decrease in research-related manufacturing for AIR001 ($0.1 million). The increase in external clinical study fees and expenses was due primarily to increased costs related to the Phase 2 study of vepoloxamer in heart failure ($0.5 million) and the EPIC study ($0.3 million), offset by a decrease

related to discontinuation of a Phase 2 study of vepoloxamer in acute limb ischemia, which the Company began to wind-down in the third quarter of 2015 ($0.3 million).

Selling, general and administrative (SG&A) expenses for the first quarter of 2016 were $2.8 million, a decrease of $0.8 million, or 21%, compared to $3.6 million for the same period in 2015. SG&A expenses for the first quarter of 2015 included $0.4 million of severance expenses and $0.3 million of share-based compensation resulting from the termination of employment of the Company’s former president and chief operating officer in February 2015 and the acceleration of stock option vesting pursuant to the terms of his option agreements.

Interest expense for the first quarter of 2016 was $0.5 million, which was related to the Company’s debt facility. There was no interest expense for the first quarter of 2015.

On May 5, 2016 AMRI (NASDAQ: AMRI) reported that it has signed a definitive agreement to acquire all outstanding shares of Prime European Therapeuticals S.p.A., also known as "Euticals", in a transaction valued at approximately $358 million (EUR 315 million), consisting of shares of AMRI common stock, cash, and a seller note (Filing, 8-K, Albany Molecular Research, MAY 6, 2016, View Source [SID:1234512067]).

Euticals is a privately-held company headquartered in Lodi, Italy, specializing in custom synthesis and the manufacture of active pharmaceutical ingredients (APIs). It operates a network of API facilities primarily in Italy, Germany, U.S. and France.

"The acquisition of Euticals will provide us an established custom synthesis presence in Europe and will further build on our expertise in complex APIs, positioning AMRI as a preeminent provider of contract research, development and manufacturing services to the pharmaceutical industry," said William S. Marth, AMRI’s president and chief executive officer.

"Euticals’ expertise with niche and high barrier to entry technologies and products, including certain tetracyclines, monobactams, sterile and fermented APIs and controlled substances, will be a tremendous asset to us. Additionally, Euticals’ large base of over 400 customers will provide us with a number of new large pharma, biotech and generics partners, further extending our global reach and diversifying our revenue.

"Importantly, I am pleased that in connection with the closing of the transaction, Fernando Napolitano will be joining our Board of Directors on behalf of Lauro Cinquantesette, S.p.A (Lauro 57) and its majority investors, Clessidra Capital Partners II and Mandarin Capital Partner SCA SICAR. Clessidra’s and Mandarin’s combined expertise, deep contacts within the European pharmaceutical community and continued guidance will be invaluable to our efforts going forward. Margalit Fine, Euticals’ chief executive officer and former head of European API at Teva, will be leading Euticals’ operations as a senior executive for the combined company," Mr. Marth said.

"On behalf of Lauro 57 and its investors, we couldn’t be more pleased to be joining AMRI," said Clessidra Chief Executive Officer, Maurizio Bottinelli. "Its expertise in developing and manufacturing complex pharmaceutical products is well known and we look forward to joining forces to further expand our presence in the European community."

Strategic Benefits of the Transaction

· Significantly expands AMRI’s capabilities in custom and complex APIs

o Provides AMRI with an established European custom synthesis presence
o Expands expertise in multiple areas: sterile API, steroids, generics, fermentation, controlled substances and monobactams
o Provides an API portfolio that includes 50 active US Drug Master Files (DMFs), 17 EU Certificates of Suitability (COS) or Compliance with the European Pharmacopeia (CEP), 13 Japanese DMFs and 6 South Korean DMFs; with several APIs having filings in more than one of these areas and over two dozen other international filings

· Provides AMRI with global scale and a diverse customer and revenue base

o Euticals brings over 400 customers with no customer concentration
o With 75% of revenue outside North America, Euticals opens up many new markets for AMRI; more than half AMRI’s combined proforma revenue is expected to be ex U.S.
o Euticals brings additional portfolio diversification in generics; AMRI to leverage U.S. base to include Euticals’ strong generic portfolio

Euticals operates a highly regarded API, custom synthesis and fine chemical development and manufacturing business with 2015 revenue and EBITDA of approximately $245 million and $27 million respectively. On a stand-alone basis, Euticals’ full year 2016 revenue is forecast to be between $245 million and $255 million, with adjusted EBITDA1 of between $34 million and $38 million, implying a purchase price multiple, prior to anticipated synergies, of approximately 9.9 times 2016 adjusted EBITDA at the midpoint of the range and excluding deal related costs or purchase accounting impacts. The transaction is expected to be accretive to AMRI’s 2016 non-GAAP diluted earnings per share. AMRI expects to generate operational synergies of $13 to $15 million over the next three years. On a pro forma basis including synergies, AMRI’s full year 2017 revenue is forecast to exceed $750 million, with adjusted EBITDA margins of approximately 20%.

Transaction Details, Financing and Closing

AMRI expects to finance the transaction through the issuance of approximately 7 million shares of AMRI common stock (currently valued at $110 million, equal to approximately 19.75% of AMRI common stock); a seller note of $63 million; and the remainder in cash. Including Euticals, AMRI believes that it will have the financial strength to manage its increased debt and plans to de-lever based on a combination of EBITDA growth and/or principal re-payments.

AMRI has entered into debt financing commitments with JP Morgan and Barclays for amounts that are expected to be sufficient to provide funds necessary to consummate the transaction. In addition to the financing, the closing of the transaction is subject to customary closing conditions, including Hart-Scott-Rodino clearance in the U.S.

1EBITDA reflects IFRS with an adjustment to U.S. GAAP only for capitalization of R&D expenses

The 7 million shares of AMRI common stock (the "Shares") to be issued in connection with the transaction will be offered and sold outside the United States to Lauro 57, an eligible investor pursuant to Regulation S of the Securities Act of 1933, as amended (the "Securities Act").

The Shares have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration under or an applicable exemption from such registration requirements. This press release does not constitute an offer to sell, or a solicitation of an offer to purchase, the Shares in any jurisdiction in which such offer or solicitation would be unlawful.

Nomura acted as exclusive financial advisor to AMRI in connection with this transaction and Goodwin Procter LLP and LCA Studio Legale acted as AMRI’s legal advisors. Lincoln International acted as sole financial advisor to Lauro 57, and Chiomenti Studio Legale and Debevoise & Plimpton LLP acted as Lauro 57’s legal advisors.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, such as EBITDA, which is adjusted to exclude, among other things, the impact of interest income and expense, depreciation and amortization expense, and income tax expense or benefit. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. There are limitations in using non-GAAP financial measures, as they are not prepared in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often-one-time charges, and is consistent with how management measures and forecasts the company’s performance, especially when comparing such results to prior periods or forecasts. Non-GAAP results also allow investors to compare the company’s operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. It is not feasible to provide reconciliation to the most comparable projected U.S. GAAP measure because the excluded items are difficult to predict and estimate and are primarily dependent on future events.

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On May 6, 2016 PharMerica Corporation (NYSE:PMC), a national provider of institutional, specialty home infusion, hospital and oncology pharmacy services, reported its financial results for the first quarter ended March 31, 2016 (Press release, PharMerica, MAY 6, 2016, View Source;p=RssLanding&cat=news&id=2166002 [SID:1234512064]).

1Q’16 Results
Comparison to
1Q’15

Comparison to
4Q’15
Revenue $524.5 million Increase of 2.5% Increase of 0.7%
Adjusted EBITDA $30.3 million Decrease of 14.4% Decrease of 12.7%
Adjusted diluted earnings per share
$0.45 Decrease of 21.1% Decrease of 19.6%
Gross profit $82.0 million Decrease of 7.4% Decrease of 5.4%
Selling, general and administrative $57.0 million Decrease of 3.4% Increase of 2.9%
Generic drug dispensing rate
86.6% Increase of 130 basis points Increase of 30 basis points

Greg Weishar, PharMerica Corporation’s Chief Executive Officer, said, "PharMerica’s first quarter 2016 exceeded our expectations. We believe we are well positioned to deliver on our 2016 financial objectives while driving continued growth and shareholder value creation.

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"Prescriptions dispensed in the first quarter of 2016 were 8.6 million as compared to 8.4 million in the fourth quarter of 2015 and 8.2 million in the third quarter of 2015. This quarter represents the second sequential quarterly increase in prescription volume. In addition, we continue to improve the generic drug dispensing rate; this quarter’s rate of 86.6% represents a 130 basis point increase versus the first quarter of 2015. We expect the generic dispensing rate to further improve as brand patent expirations occur throughout this year and beyond.

"Also, we continue to make progress with respect to the diversification program. Specialty home infusion, oncology and hospital pharmacy management revenues grew 47% on a year over year basis. We achieved revenue growth both organically and through acquisitions. Importantly, EBITDA is growing faster than revenues as higher prescription volumes drive operating leverage. We are confident diversified revenues will exceed $700 million in 2017, and the diversification program will meaningfully contribute to the Company’s overall EBITDA growth over the next several years.

Mr. Weishar concluded, "In summary, we are off to a good start in 2016, and we will continue to pursue attractive acquisitions that drive share and scale. We remain optimistic about the Company’s long-term prospects, and we are well positioned to return to strong growth in 2017 and beyond."

Full Year 2016 Financial Guidance

PharMerica reaffirms its full year 2016 guidance metrics:

Revenue in the range of $2.125 billion to $2.150 billion;
Adjusted EBITDA in the range of $130.3 million to $135.3 million; and
Adjusted diluted earnings per share in the range of $1.95 to $2.05.
The Company notes that its 2016 guidance does not include the effect of any future 2016 acquisitions.

First Quarter 2016 Results

The results for the first quarter 2016 are set forth below:

Key Comparisons of First Quarters Ended March 31, 2016 and 2015:
Revenues for the first quarter of 2016 were $524.5 million compared with $511.6 million for the first quarter of 2015, an increase of 2.5%. The increase in revenues of $12.9 million is due to significant organic growth and acquisitions in the Company’s specialty businesses, partially offset by the 2015 initiative to improve the overall quality mix of clients, the 2016 reduction in Medicare Part D reimbursement and 2015 brand to generic conversions.

Gross profit for the first quarter of 2016 was $82.0 million compared with $88.6 million in the first quarter of 2015; a decrease of 7.4%. The decrease in gross profit was driven by higher drug costs under the Cardinal Health prime vendor agreement, changes made in 2015 to improve the overall quality mix of clients and lower Medicare Part D reimbursement.

Selling, general and administrative expenses were $57.0 million or 10.9% of revenues for the three months ended March 31, 2016 compared to $59.0 million or 11.5% of revenues for the three months ended March 31, 2015. The decrease of $2.0 million was due to cost improvements and lower bad debt expense.
Adjusted EBITDA for the first quarter of 2016 was $30.3 million compared with $35.4 million in the first quarter of 2015; a decrease of 14.4%.

Net income for the first quarter of 2016 was $4.1 million, or $0.13 diluted earnings per share, compared to $9.6 million, or $0.31 diluted earnings per share, for the same period in 2015. Adjusted diluted earnings per share was $0.45 in the first quarter of 2016 compared to $0.57 in the first quarter of 2015.

Cash flows provided by operating activities for the first quarter of 2016 were $62.3 million compared with $44.3 million in the first quarter of 2015. The increase in cash from operating activities is due to a decrease in inventory purchases and a higher accounts payable balance due to the timing of the weekly Cardinal Health prime vendor payment. Additionally, in the first quarter of 2015, $48.8 million of AmerisourceBergen drug purchase payments were withheld.

On May 6, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the first quarter ended March 31, 2016 (Filing, Q1, Oncolytics Biotech, 2016, MAY 6, 2016, View Source [SID:1234512055]).

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"We recently reported data from two sponsored, randomized Phase 2 studies, highlighting reduced tumor burden in ovarian cancer and improved longer term survival in pancreatic cancer," said Dr. Brad Thompson. "The data from these studies will be very useful in identifying potential indications and study designs that we could advance into later stage studies in the future."

Selected Highlights

Since January 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Treatment of the first patients in a Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with paclitaxel in patients with ovarian cancer (GOG-0186H), where an intent-to-treat analysis, as assessed by CA-125 antigen levels, showed statistically significantly reduction in tumor burden;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research

· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Financial

· Entry into an "at-the-market" equity distribution agreement with Canaccord Genuity Corp. permitting Oncolytics at its sole discretion, from time to time and until March 16, 2018, to sell common shares having an aggregate offering value of up to $4.6 million; and
· At March 31, 2016 the Company reported $22.3 million in cash, cash equivalents and short-term investments. At May 5, 2016, the Company had approximately $21.4 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies as well as both a run-in and a registration study in muscle-invasive bladder cancer.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As at March 31,
2016
$ December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 20,233,408 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 59,648 340,059
Prepaid expenses 229,288 506,669
Total current assets 22,611,144 26,923,980

Non-current assets
Property and equipment 411,762 459,818
Total non-current assets 411,762 459,818

Total assets 23,022,906 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,554,338 2,709,492
Total current liabilities 2,554,338 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
March 31, 2016 – 118,697,122
December 31, 2015 – 118,151,622 261,224,148 261,324,692
Contributed surplus 26,359,606 26,277,966
Accumulated other comprehensive income 590,919 760,978
Accumulated deficit (267,706,105) (263,689,330)
Total shareholders’ equity 20,468,568 24,674,306
Total liabilities and equity 23,022,906 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

2016 2015
For the three month period ending March 31 $ $
Expenses
Research and development 2,726,129 2,425,539
Operating 1,360,412 1,182,734
Operating loss (4,086,541) (3,608,273)
Interest 69,621 56,435
Loss before income taxes (4,016,920) (3,551,838)
Income tax expense 145 —
Net loss (4,016,775) (3,551,838)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment (170,059) 225,591

Net comprehensive loss (4,186,834) (3,326,247)
Basic and diluted loss per common share (0.03) (0.04)

Weighted average number of shares (basic and diluted) 118,199,985 99,557,654

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY


Share Capital
$

Contributed
Surplus
$

Accumulated
Other
Comprehensive
Income
$

Accumulated
Deficit
$

Total
$

As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193

Net loss and comprehensive income — — 225,591 (3,551,838) (3,326,247)
Issued, pursuant to Share Purchase
Agreement 1,925,596 — — — 1,925,596
Issued, pursuant to "At the Market"
Agreement 14,636,918 — — — 14,636,918
Share based compensation — 114,970 — — 114,970
As at March 31, 2015 254,219,570 25,963,399 505,634 (253,518,173) 27,170,430

Share Capital
$

Contributed
Surplus
$

Accumulated
Other
Comprehensive
Income
$

Accumulated
Deficit
$

Total
$

As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306

Net loss and comprehensive income — — (170,059) (4,016,775) (4,186,834)
Issued, pursuant to Share Purchase
Agreement
— — — — —
Issued, pursuant to "At the Market"
Agreement (100,544) — — — (100,544)
Share based compensation — 81,640 — — 81,640
As at March 31, 2016 261,224,148 26,359,606 590,919 (267,706,105) 20,468,568

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

2016 2015
For the three month period ending March 31 $ $

Operating Activities
Net loss for the period (4,016,775) (3,551,838)
Amortization – property and equipment 45,942 45,130
Share based compensation 81,640 114,970
Impact of unrealized foreign exchange (gains) losses 141,295 (305,156)
Net change in non-cash working capital 724,655 949,705
Cash used in operating activities (3,023,243) (2,747,189)

Investing Activities
Acquisition of property and equipment — (11,940)
Purchase of short-term investments (27,823) (29,292)
Cash used in investing activities (27,823) (41,232)

Financing Activities
Proceeds from Share Purchase Agreement — 1,925,596
Proceeds from "At the Market" equity distribution agreement (100,544) 14,636,918
Cash provided by financing activities (100,544) 16,562,514
(Decrease) increase in cash (3,151,610) 13,774,093
Cash and cash equivalents, beginning of period 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents (631,257) 651,105
Cash and cash equivalents, end of period 20,233,408 28,578,023

To view the Company’s Fiscal 2016 First Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

On May 6, 2016 Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE:OXB), a leading gene and cell therapy company, reported that new data has been presented from two clinical studies indicating ground-breaking long-term four-year sustained and, in one of the studies, dose-dependent gene expression with the Company’s LentiVector delivery platform (Press release, Oxford BioMedica, MAY 6, 2016, View Source [SID:1234512034]).

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On 5 May 2016, Professor Stéphane Palfi presented a poster on OXB-101, a gene therapy product for the treatment of Parkinson’s disease (PD), at the 19th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Washington DC, USA. In the Phase I/II study 15 advanced PD patients were treated with OXB-101 in three dose cohorts. OXB-101 demonstrated a favourable safety profile and a statistically significant improvement in motor function relative to baseline at six and 12 months post-treatment. The most recent follow-up data, presented this week, shows that the majority of patients continue to experience improvement in motor function relative to baseline over the four years since treatment. The Company has since developed OXB-102, a more potent version of OXB-101, and is planning to start a Phase I/II study in mid-2016. OXB-102 is Oxford BioMedica’s gene therapy product that utilises its proprietary LentiVector delivery platform to transfer three genes for dopamine synthesis in the striatum.

In addition, on 4 May 2016, Dr Andreas Lauer gave an oral presentation on Oxford BioMedica’s LentiVector-based treatment for neovascular age-related macular degeneration (wet AMD), at the Association for Research in Vision and Ophthalmology (ARVO) conference in Seattle, USA. Consistent with results previously announced at the ARVO conference, the new data presented demonstrates that LentiVector gene expression was dose-dependent and continued without significant decline for more than four years.

Commenting on the new emerging data, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "We are very encouraged by the demonstration of long term expression and clinical benefit in patients indicated by the four-year follow-up data from these two clinical studies. We believe this is the first time gene therapy products have been directly measured in the eye and the longevity in both expression and efficacy to date reinforces the benefits of the Company’s pioneering LentiVector gene delivery platform in the treatment of chronic conditions."

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