On May 10, 2016 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, reported results for its second quarter ended March 31, 2016 (Press release, Ohr Pharmaceutical, MAY 10, 2016, View Source [SID:1234512219]).

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"We achieved a number of important milestones in advancing our lead drug candidate, Squalamine, during the first few months of 2016," said Jason S. Slakter, MD, Chief Executive Officer of Ohr. "In commencing the enrollment of patients in our Phase 3 clinical program, we move closer to potentially providing a much-needed, safe and efficacious new treatment for patients with neovascular age-related macular degeneration or wet AMD. Importantly, we are conducting the Phase 3 trials under an agreed upon Special Protocol Assessment (SPA) with the United States Food and Drug Administration. The trials are designed to generate data to support regulatory approval of Squalamine in the United States and other major ophthalmic markets worldwide."

Second Quarter and Recent 2016 Clinical and Pre-Clinical Highlights

Enrolled the first patient in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% ("Squalamine," also known as OHR-102), when administered as part of a combination therapy, as a treatment to improve visual function for patients with wet AMD.
The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
The first of the two randomized trials will include approximately 165 centers in the United States and Canada and has a target enrollment of 650 treatment naïve subjects with wet AMD.
The primary endpoint in both studies will be a measurement of visual acuity gains at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
Reached an agreement on a Special Protocol Assessment (SPA) with the United States Food and Drug Administration on the design of the Phase 3 trials for Squalamine.
Presented two posters at the Association for Research in Vision and Ophthalmology (ARVO) Conference, which took place May 1 through May 5 in Seattle, Washington.
CNV Lesion Characteristics as a Predictor of Visual Outcomes in Wet AMD Patients Receiving Combination Therapy with Ranibuzimab (Lucentis) and topical Squalamine Lactate Ophthalmic Solution (David M. Brown et al). Included detailed analysis of lesion characteristics as predictors of visual outcome in the previously conducted Phase 2 IMPACT trial, and demonstrated that combination therapy with Squalamine was most effective in those patients whose occult component was less than 10mm2. These new data support the choice of the target population in the ongoing Phase 3 registration program.
Sustained Retinal Concentrations of OHR3031 Achieved with Intravitreal Injection of a Biodegradable Microparticle Formulation to Rabbits (Modi et al). This poster discussed the use of Ohr’s proprietary sustained release technology to successfully deliver supratherapeutic concentrations of OHR3031, a novel small molecule anti-angiogenic compound, to target tissues in the back of the eye.
Financial Results for Second Quarter ended March 31, 2016

For the second quarter ended March 31, 2016, the Company reported a net loss of approximately $5.3 million, or ($0.17) per share, compared to a net loss of approximately $3.4 million, or ($0.12) per share in the same period of 2015.
For the second quarter ended March 31, 2016, total operating expenses were approximately $6.6 million, consisting of approximately $3.0 million in general and administrative expenses, $4.0 million in research and development expenses, $0.3 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable. This compares to total operating expenses in the same period of 2015 of approximately $6.8 million, consisting of $3.3 million in general and administrative expenses, $3.2 million in research and development expenses, and $0.3 million in depreciation and amortization.
At March 31, 2016, the Company had cash and cash equivalents of approximately $21.9 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
Financial Results for the Six-Months ended March 31, 2016

For the six months ended March 31, 2016, the Company reported a net loss of approximately $11.4 million, or ($0.37) per share, compared to a net loss of approximately $7.9 million, or ($0.30) per share in the same period of 2015.
For the six months ended March 31, 2016, total operating expenses were approximately $10.2 million, consisting of $4.2 million in general and administrative expenses, $6.1 million of research and development expenses, $0.6 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable. This compares to total operating expenses of $10.7 million in the same period of 2015, comprised of approximately $4.2 million in general and administrative expenses, $5.9 million in research and development expenses, and $0.6 million in depreciation and amortization.

On May 10, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported its financial results and recent corporate highlights for the quarter ended March 31, 2016 (Filing, Q1, Fortress Biotech, 2016, MAY 10, 2016, View Source [SID:1234512260]).

Dr. Lindsay A. Rosenwald, Chairman, President and CEO of Fortress, said, "This year, we have continued to build our portfolio of products under development and Journey Medical Corporation’s roster of marketed products. We have also made significant progress advancing the pipeline of many of our other Fortress Companies, including Mustang Bio, which presented positive initial Phase I data on its CAR-T therapy MB-101 for the treatment of glioblastoma at the American Society of Gene and Cell Therapy 19th Annual Meeting. In addition, we are excited to possibly bring National Holdings Corporation under the Fortress umbrella with the goal of building a world-class biotech and life sciences investment banking operations franchise. In 2016, we plan to continue to seek business development opportunities for Fortress and our Fortress Companies, as we expand our therapeutic focus and advance multiple milestones in our robust pipeline. We look forward to another transformative year in support of our mission of rapidly advancing meaningful treatments to people in need."

Financial Results:

· At March 31, 2016, Fortress’ consolidated cash and cash equivalents totaled $81.4 million compared to $98.2 million at December 31, 2015, a decrease of $16.8 million for the quarter. These totals exclude restricted cash of $14.6 million. The majority of the cash payments were related to Fortress and Fortress Companies previously accrued liabilities and upfront fees.
· Revenue totaled $0.7 million for the first quarter of 2016.
· Research and development expenses were $7.7 million for the first quarter of 2016, compared to $1.6 million for the first quarter of 2015.
· General and administrative expenses were $7.9 million for the first quarter of 2016, compared to $3.5 million for the first quarter of 2015.
· Net loss was $12.2 million, or $0.31 per share, for the first quarter of 2016, compared to a net loss of $12.1 million, or $0.31 per share, for the first quarter of 2015.
· Noncash stock-based compensation expense included in net loss for the first quarter of 2016 was $2.9 million, compared to $1.5 million for the first quarter of 2015.

Recent Corporate Highlights:

Avenue Therapeutics, Inc.

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· During the three months ended March 31, 2016, Avenue completed a pharmacokinetics (PK) study for intravenous (IV) Tramadol.

Checkpoint Therapeutics, Inc.

· In February 2016, Checkpoint repaid its National Securities Corporation (NSC) Debt of $2.8 million.

FBIO Acquisition, Inc.

· In April 2016, Fortress, FBIO Acquisition, Inc. and National Holdings Corporation ("NHLD") entered into an agreement and plan of merger for the acquisition of NHLD by FBIO Acquisition, Inc.

Helocyte, Inc.

· In February 2016, Helocyte entered into an Investigator-Initiated Clinical Research Support Agreement with the City of Hope National Medical Center, to support a Phase 2 clinical study of its Triplex immunotherapy for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Cancer Institute.
· In February 2016, Helocyte entered into an option agreement with The University of Texas Health Science Center at Houston, for the exclusive rights to license certain intellectual property and clinical data relating to the use of bone marrow derived mononuclear cells for the treatment of severe Traumatic Brain Injury.
· In March 2016, Helocyte entered into an Investigator-Initiated Clinical Research Support Agreement with the City of Hope National Medical Center, to support a Phase 2 clinical study of its PepVax immunotherapy for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Cancer Institute.

Journey Medical Corporation (JMC)

· In January 2016, JMC entered into a licensing agreement with a third party to distribute a prescription wound cream. JMC intends to commercialize this product in the second quarter of 2016.
· In January 2016, JMC entered into a licensing agreement with a third party to distribute an emollient for the treatment of various types of dermatitis. JMC intends to commercialize this product in the second quarter of 2016.
· Both products will be marketed under the JMC brand.

Mustang Bio, Inc.

· In April 2016, Mustang announced that two abstracts pertaining to MB-101 (IL13Rα2-specific CAR T cells) for the treatment of glioblastoma were selected for presentation at the American Society of Gene and Cell Therapy 19th Annual Meeting (ASGCT) (Free ASGCT Whitepaper). Pre-clinical and preliminary Phase I data were presented at ASGCT (Free ASGCT Whitepaper) on Thursday, May 5.

Curegenix is developing drug candidates targeting a key stem cell pathway in cancer (Company Web Page, Curegenix, MAY 10, 2016, View Source [SID:1234512167]). Our "first-in-class"/"best-in-class" compound CGX1321 for treating gastrointestinal (GI) cancers has completed all IND-enabling studies . We now seek VC investment to advance CGX1321 into clinical development.

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On May 10,2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2016 (Press release, Puma Biotechnology, MAY 10, 2016, View Source [SID:1234512220]).

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Unless otherwise stated, all comparisons are for the first quarter 2016 compared to the first quarter 2015.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $71.0 million, or $2.19 per share, for the first quarter of 2016, compared to a net loss applicable to common stock of $52.5 million, or $1.66 per share, for the first quarter of 2015.

Non-GAAP adjusted net loss was $41.5 million, or $1.28 per share, for the first quarter of 2016, compared to non-GAAP adjusted net loss of $32.4 million, or $1.02 per share, for the first quarter of 2015. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release. The Company anticipates that non-GAAP net loss will decrease in subsequent quarters due to an expected reduction in clinical trial expenses and the completion of the regulatory filings for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in the United States and Europe.

Net cash used in operating activities for the first quarter of 2016 was $35.0 million. At March 31, 2016, Puma had cash and cash equivalents of $78.2 million and marketable securities of $103.0 million, compared to cash and cash equivalents of $31.6 million and marketable securities of $184.3 million at December 31, 2015. The Company anticipates that net cash used in operating activities will be lower in subsequent quarters due to a reduction in the expenses described above.

"To date in 2016, we have achieved a number of key milestones, including publication of the results of the Phase III ExteNET trial of neratinib in the extended adjuvant treatment of HER2-positive early stage breast cancer in The Lancet Oncology, the publication of neratinib in the front-line treatment of HER2-positive metastatic breast cancer (NEfERT-T Phase II trial) in JAMA Oncology in April, and numerous presentations on neratinib in HER2 non-amplified breast cancer that has a HER2 mutation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our near term focus is on the filing of our regulatory submissions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer, which we anticipate will occur in mid-2016 and the second quarter of 2016, respectively.

"We look forward to continuing our development of neratinib during 2016. We anticipate (i) submitting a New Drug Application (NDA) to the FDA in mid-2016 and submitting a Marketing Authorization Application (MAA) to the EMA during the second quarter of 2016 for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer based on the positive ExteNET Phase III trial; (ii) reporting additional data from the Phase II trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide prophylaxis during the second quarter of 2016; (iii) reporting additional Phase II data from the FB-7 neoadjuvant HER2-positive breast cancer trial in the subgroup of patients who are MammaPrint High during the second quarter of 2016; (iv) reporting Phase II data from an investigator sponsored trial of neratinib in patients with HER2-negative breast cancer who have a HER2 mutation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016; (v) reporting data from the Phase III trial of neratinib in third-line HER2-positive metastatic breast cancer patients in either the fourth quarter of 2016 or the first quarter of 2017; (vi) reporting data from the Phase II trial of neratinib in metastatic breast cancer patients with brain metastases during the fourth quarter of 2016; and (vii) reporting data from the Phase II trial of neratinib plus fulvestrant in patients with HER2 non-amplified breast cancer that has a HER2 mutation during the fourth quarter of 2016."

Operating Expenses

Operating expenses were $71.2 million for the first quarter of 2016, compared to $52.6 million for the first quarter of 2015.

General and Administrative Expenses:

General and administrative expenses were $11.0 million for the first quarter of 2016, compared to $7.9 million for the first quarter of 2015. The approximately $3.1 million increase resulted primarily from increases of approximately $1.2 million for stock-based compensation, $1.3 million for professional fees, $0.4 million for payroll and related costs, and $0.2 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $60.2 million for the first quarter of 2016, compared to $44.7 million for the first quarter of 2015. The approximately $15.5 million increase resulted primarily from increases of approximately $8.2 million for stock-based compensation, $4.3 million for clinical trial expenses, $2.6 million for internal R&D and related expenses, and $0.4 million for consultants and contractors. We expect R&D expenses to decrease in subsequent quarters as we complete clinical trials and file for regulatory approvals for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in the United States and European Union.

On May 10, 2016 Allergan plc (NYSE: AGN) reported strong performance with net revenue from continuing operations increasing 48 percent to $3.8 billion for the quarter ended March 31, 2016, compared to $2.6 billion in the first quarter 2015 (Press release, Allergan, MAY 10, 2016, View Source;p=irol-newsArticle&ID=2166833 [SID:1234512266]). On a non-GAAP basis, diluted earnings per share from continuing operations increased 15 percent to $3.04 for the first quarter 2016, compared to $2.65 in the first quarter 2015. GAAP loss from continuing operations per diluted share for the first quarter 2016 was $0.38, compared to GAAP loss from continuing operations per diluted share of $2.80 in the prior year period. GAAP results were impacted by amortization, acquisition-related expenses, research and development (R&D) expenses resulting from the acquisition of R&D assets from Anterios, Pfizer-related expenses, acquisition accounting valuation related expenses and severance associated with acquired businesses, mainly the acquisition of Allergan on March 17, 2015. These results include Allergan results as of the date of the close of the acquisition, March 17, 2015.

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"Allergan once again delivered strong performance in the first quarter of 2016, powered by double-digit pro forma branded revenue growth2 and our top global products within the U.S. Brands, U.S. Medical and International Brands segments. We also grew our Non-GAAP EPS by 15 percent, marking the seventh consecutive quarter of double-digit, year-over-year EPS growth since I became the CEO in July 2014," said Brent Saunders, CEO and President of Allergan. "Thanks to the effort of our 30,000 colleagues around the world, Allergan remains the most dynamic and exciting company in our industry. That dynamism is evident in our results, in the way we operate our business, in the way we build category leadership through our Open Science model and in our highly responsive, service oriented approach to customers."

"Our branded business continues to grow at a fast pace and is very well positioned in each of our seven therapeutic areas. As we look ahead, we see durable global brands with strong fundamentals, broad-based geographic expansion, and many opportunities to continue growing our innovative business," added Saunders.

For the first quarter 2016, adjusted EBITDA from continuing operations increased 65 percent to $1.8 billion, compared to $1.1 billion for the first quarter 2015. Non-GAAP operating income from continuing operations in the first quarter 2016 was $1.75 billion. GAAP operating loss from continuing operations in the first quarter 2016 was $154 million. Cash flow from operations for the first quarter of 2016 was $1.2 billion and cash and marketable securities were $2.3 billion as of March 31, 2016. Cash from operations in the quarter was impacted by the acquired R&D assets from Anterios and integration expenses.

_____________________________________
1 Excludes Fx impact, Namenda IR and divestitures
2 Excludes Fx impact, Namenda IR and divestitures

Operating Expenses
Total non-GAAP SG&A was $1.0 billion for the first quarter 2016 compared to $609 million in the prior year period. Non-GAAP R&D investment for the first quarter 2016 was $277 million. As of March 31, 2016, the Company had outstanding indebtedness of $42.6 billion primarily as a result of legacy Allergan, Forest and other recent acquisitions.

Amortization and Tax
Amortization expense for the first quarter 2016 was $1.6 billion, compared to $788 million in the first quarter of 2015. The increase was primarily due to the Allergan acquisition.

The Company’s non-GAAP continuing operations tax rate was 9.7 percent in the first quarter 2016. The Company experienced a benefit to its tax rate as a result of the impact of its entire interest expense being included within continuing operations earnings.

Top Global Branded Product Highlights
The following table represents revenue from Allergan’s top promoted products.

ALLERGAN PLC
NET REVENUES TOP GLOBAL PRODUCTS
(Unaudited; in millions)

Three Months Ended March 31,

Global

U.S.

International

2016

2015

$ Change
% Change

2016

2015

$ Change
% Change

2016

2015

$ Change
% Change

Botox

$ 637.5

$ 84.0

$ 553.5
n.m.

$ 455.5

$ 60.7

$ 394.8
n.m.

$ 182.0

$ 23.3

$ 158.7
n.m.
Restasis

313.7

29.9

283.8
n.m.

298.7

28.7

270.0
n.m.

15.0

1.2

13.8
n.m.
Fillers

214.7

24.6

190.1
n.m.

114.1

12.8

101.3
n.m.

100.6

11.8

88.8
n.m.
Namenda XR

173.1

150.6

22.5
14.9%

173.1

150.6

22.5
14.9%

–

–

–
n.a.
Lumigan/Ganfort

169.6

21.2

148.4
n.m.

81.5

8.1

73.4
n.m.

88.1

13.1

75.0
n.m.
Bystolic

164.0

164.1

(0.1)
(0.1)%

163.6

163.7

(0.1)
(0.1)%

0.4

0.4

–
0.0%
Linzess/Constella

140.9

96.2

44.7
46.5%

137.1

95.5

41.6
43.6%

3.8

0.7

3.1
n.m.
Alphagan/Combigan

126.7

16.0

110.7
n.m.

84.9

10.1

74.8
n.m.

41.8

5.9

35.9
n.m.
Asacol/Delzicol

121.2

149.2

(28.0)
(18.8)%

105.9

132.0

(26.1)
(19.8)%

15.3

17.2

(1.9)
(11.0)%
Lo Loestrin

89.3

83.3

6.0
7.2%

89.3

82.7

6.6
8.0%

–

0.6

(0.6)
(100.0)%
Viibryd/Fetzima

83.3

79.6

3.7
4.6%

83.3

79.6

3.7
4.6%

–

–

–
n.a.
Estrace Cream

80.7

71.9

8.8
12.2%

80.7

71.9

8.8
12.2%

–

–

–
n.a.
Minastrin 24

80.4

65.4

15.0
22.9%

79.6

64.8

14.8
22.8%

0.8

0.6

0.2
33.3%
Silicone Implants

67.4

9.4

58.0
n.m.

33.9

2.4

31.5
n.m.

33.5

7.0

26.5
n.m.
Carafate / Sulcrate

61.5

53.6

7.9
14.7%

61.0

53.6

7.4
13.8%

0.5

–

0.5
n.a.
Ozurdex

60.5

7.0

53.5
n.m.

19.4

2.7

16.7
n.m.

41.1

4.3

36.8
n.m.
Aczone

33.0

6.0

27.0
n.m.

33.0

6.0

27.0
n.m.

–

–

–
n.a.
Namenda IR

5.8

245.4

(239.6)
(97.6)%

5.8

245.4

(239.6)
(97.6)%

–

–

–
n.a.
Other Products Revenues

807.9

650.9

157.0
24.1%

657.5

618.3

39.2
6.3%

150.4

32.6

117.8
n.m.
Total Products Revenues

3,431.2

2,008.3

1,422.9
70.9%

2,757.9

1,889.6

868.3
46.0%

673.3

118.7

554.6
467.2%
ANDA Revenues

364.7

554.3

(189.6)
(34.2)%

364.7

554.3

(189.6)
(34.2)%

–

–

–
n.a.
Total Net Revenues

$ 3,795.9

$ 2,562.6

$ 1,233.3
48.1%

$ 3,122.6

$ 2,443.9

$ 678.7
27.8%

$ 673.3

$ 118.7

$ 554.6
467.2%
For the first quarter 2016, total global branded product revenues were $3.4 billion versus $2.0 billion in the prior year quarter. Top key branded product highlights in the quarter included:

Botox revenues in the first quarter of 2016 were $638 million, driven by continued strong performance in both aesthetic and therapeutic indications.
Restasis revenues in the first quarter of 2016 were $314 million, driven by continuing strong promotional efforts.
Fillers’ revenues in the first quarter of 2016 were $215 million, reflecting continued strong performance.
Namenda XR revenues in the first quarter of 2016 were $173 million, as prescriptions and formulary coverage remained stable following the loss of exclusivity of Namenda IR.
Lumigan/Ganfort revenues in the first quarter of 2016 were $170 million reflecting stable performance across Allergan’s glaucoma product franchise.
Bystolic revenues in the first quarter of 2016 remained stable at $164 million.
Linzess/Constella revenues in the first quarter of 2016 were $141 million, driven by continued strong OTC conversion momentum and increasing sales in the long-term care market.
Asacol/Delzicol revenues in the first quarter of 2016 were $121 million, impacted by lower prescriptions and trade buying patterns.
Viibryd/Fetzima revenues in the first quarter of 2016 were $83 million, driven by double digit prescription growth in Fetzima.
Lo Loestrin revenues in the first quarter of 2016 were $89 million, driven by continuing strong demand and promotional efforts.
Minastrin and Estrace Cream revenues in the first quarter of 2016 were $80 million and $81 million, respectively.
Silicone breast implant revenues in the first quarter of 2016 were $67 million, as a result of increased market share.
First Quarter 2016 Business Segment Results

U.S. Brands

Three Months Ended

March 31,

Change
(Unaudited; in millions)
2016

2015

Dollars
%
Central Nervous System (CNS)
$ 554.3

$ 548.4

$ 5.9
1.1%
Eye care
533.0

94.7

438.3
n.m.
Gastroenterology (GI)
403.6

366.6

37.0
10.1%
Women’s Health
263.7

229.3

34.4
15.0%
Urology
74.1

37.3

36.8
98.7%
Infectious Disease
51.5

41.9

9.6
22.9%
Other
422.5

491.0

(68.5)
(14.0)%
Net revenues
$ 2,302.7

$ 1,809.2

$ 493.5
27.3%
Operating expenses:

Cost of sales(1)

259.4

218.2

41.2
18.9%
Selling and marketing

431.9

372.3

59.6
16.0%
General and administrative

68.1

58.5

9.6
16.4%
Segment contribution

$ 1,543.3

$ 1,160.2

$ 383.1
33.0%
Segment margin

67.0%

64.1%

2.9%
Segment gross margin

88.7%

87.9%

0.8%

(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results.
U.S. Brands net revenue of $2.3 billion for the first quarter 2016 represents a 27 percent increase over $1.8 billion in the first quarter of 2015. Growth was mainly attributed to the acquisition of legacy Allergan products, including Botox, Restasis, Lumigan/Ganfort, and Combigan, and strong growth from Linzess/Constella, Carafate/Sulcrate, Zenpep, Namenda XR, Lo Loestrin, Estrace Cream and Minastrin 24 and new product launches Avycaz, Dalvance and Liletta.

U.S. Brands gross margin for the first quarter of 2016 was 88.7 percent. Selling & marketing (S&M) expenses increased 16 percent in the first quarter 2016 due mainly to the acquisition of legacy Allergan and the launches of Viberzi and Vraylar offset, in part, by the impact of synergies from Forest Laboratories and Allergan acquisitions. G&A expenses increased versus first quarter 2015 reflecting the addition of legacy Allergan, which was offset by related synergies from the acquisitions of Forest Laboratories and Allergan. Overall, net segment contribution for the first quarter 2016 increased 33 percent over the prior year period to $1.5 billion primarily as a result of the Allergan acquisition.

U.S. Medical Aesthetics

Three Months Ended

March 31,

Change
(Unaudited; in millions)
2016

2015

Dollars
%
Facial Aesthetics
$ 279.4

$ 35.2

$ 244.2
n.m.
Medical Dermatology and Other
122.2

30.5

91.7
n.m.
Plastic Surgery
48.1

14.1

34.0
n.m.
Net revenues
$ 449.7

$ 79.8

$ 369.9
n.m.
Operating expenses:

Cost of sales(1)

30.9

4.5

26.4
n.m.
Selling and marketing

110.0

13.8

96.2
n.m.
General and administrative

13.3

2.7

10.6
n.m.
Segment contribution

$ 295.5

$ 58.8

$ 236.7
n.m.
Segment margin

65.7%

73.7%

(8.0)%
Segment gross margin

93.1%

94.4%

(1.3)%

(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results.
First quarter 2016 U.S. Medical Aesthetics net revenue was $450 million reflecting continued strong performance in BOTOX and Fillers including Juvederm.

U.S. Medical Aesthetics selling and marketing (S&M) expenses for the first quarter of 2016 were $110 million, and general & administrative expenses (G&A) for the first quarter of 2016 were $13 million.

U.S. Medical Aesthetics segment gross margin for the first quarter of 2016 was 93.1 percent compared to 94.4 percent in the prior year quarter.

International Brands

Three Months Ended

March 31,

Change
(Unaudited; in millions)
2016

2015

Dollars
%
Eye care
$ 291.5

$ 40.5

$ 251.0
n.m.
Facial Aesthetics
205.5

24.8

180.7
n.m.
Other Therapeutics
139.5

45.6

93.9
n.m.
Plastic Surgery
36.8

7.8

29.0
n.m.
Net revenues
$ 673.3

$ 118.7

$ 554.6
n.m.
Operating expenses:

Cost of sales(1)

99.2

23.7

75.5
n.m.
Selling and marketing

187.3

42.3

145.0
n.m.
General and administrative

27.6

7.4

20.2
n.m.
Segment contribution

$ 359.2

$ 45.3

$ 313.9
n.m.
Segment margin

53.3%

38.2%

15.1%
Segment gross margin

85.3%

80.0%

5.3%

(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results.
International Brands net revenues for the first quarter of 2016 was $673 million compared to $119 million in the first quarter of 2015. Growth was mainly attributed to revenues associated with acquired legacy Allergan products, including Botox, Juvederm and Ozurdex.

International Brands selling and marketing (S&M) expenses for the first quarter of 2016 were $187 million, and general & administrative expense (G&A) were $28 million. International Brands segment gross margin for the first quarter of 2016 was 85.3 percent compared to 80.0 percent in the prior year quarter.

Anda Distribution

Three Months Ended

March 31,

Change
(Unaudited; in millions)
2016

2015

Dollars
%
Net revenues
$ 364.7

$ 554.3

$ (189.6)
(34.2)%
Operating expenses:

Cost of sales(1)

302.9

473.5

(170.6)
(36.0)%
Selling and marketing

28.8

37.6

(8.8)
(23.4)%
General and administrative

10.2

10.8

(0.6)
(5.6)%
Segment contribution

$ 22.8

$ 32.4

$ (9.6)
(29.6)%
Segment margin

6.3%

5.8%

0.5%
Segment gross margin

16.9%

14.6%

2.3%

(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results.
Anda Distribution net revenues for the first quarter of 2016 were $365 million, reflecting a $189.6 million decline primarily due to the loss of Target Corporation business due to CVS Health acquiring Target’s in store pharmacies.

Anda Distribution gross margin for the first quarter of 2016 was 16.9 percent compared to 14.6 percent in the previous year period.

Discontinued Operations
As a result of the proposed divestiture of Allergan’s Global Generics business to Teva on July 27, 2015, the financial results of the Company’s Global Generics business are being reported as discontinued operations in the condensed consolidated statements of operations. These portions of the Company’s results will continue to be reported as discontinued operations until the close of that transaction. Continuing operations includes the U.S. Brands, U.S. Medical, International Brands and Anda Distribution segments. All prior year results have been recast to reflect continuing operations results.

Pipeline Update
R&D productivity continued during the quarter. Key development highlights included:

First Quarter U.S. and International Branded Product Approvals and Launches

ACZONE (dapsone) Gel, 7.5%, received U.S. Food and Drug Administration (FDA) approval for the topical treatment for acne in patients 12 years of age and older.
BOTOX (onabotulinumtoxinA) received FDA approval for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles.
DALVANCE (dalbavancin) for injection received FDA approval for its supplemental New Drug Application (sNDA) and EU approval to expand the product’s label. The expanded label includes a single-dose administered as a 30-minute intravenous (IV) infusion of DALVANCE for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
Allergan launched VRAYLAR (cariprazine), a once-daily oral atypical antipsychotic in the U.S. VRAYLAR was approved by the FDA in September 2015 for the treatment of acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults.
First Quarter 2016 Regulatory Milestones & Clinical Updates

Allergan announced that rapastinel (GLYX-13) received Breakthrough Therapy designation from the FDA for adjunctive treatment of Major Depressive Disorder (MDD). This follows the Fast Track Designation for rapastinel granted by the FDA in 2014.
Allergan announced that the FDA accepted for filing the company’s supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include the treatment of children two months of age and older with acute bacterial skin and skin structure infections (ABSSSI) including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP) caused by Staphylococcus pneumoniae and other designated susceptible bacteria.
Allergan announced that the FDA accepted for filing the company’s supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam). This filing will add important new clinical data to the current label from two Phase 3 trials evaluating the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI), including patients with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens.
Allergan has submitted an NDA to the FDA for Oxymetazoline, a potential treatment for rosacea.
Allergan submitted an sNDA to the FDA for Linzess 72 mcg for the treatment of Chronic Idiopathic Constipation (CIC).
Allergan submitted an sNDA to the FDA for a single-inserter with optimized packaging for use with Liletta.
FDA accepted an NDA submission for SER 120, an investigational treatment for nocturia.
Top-line results from the first Phase 3 study of Ulipristal Acetate were reported in the first half of 2016. The study met all co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001).
Allergan initiated a Phase 3 study for Cariprazine in Bipolar Depression in the first half of 2016.
Full Year 2016 Continuing Operations Guidance
Allergan’s full year 2016 continuing operations standalone estimates are based on management’s current belief about prescription trends, pricing levels, inventory levels and the anticipated timing of future product launches and events. Continuing operations includes the U.S. Brands, U.S. Medical, International Brands and Anda distribution segments.

Total Non-GAAP Net Revenues are expected to be ~$17 Billion
Non-GAAP Branded Net Revenues are expected to be ~$15 Billion (10% Growth1)
No material changes to gross margin from current levels in each segment
Non-GAAP R&D investment is expected to be ~$1.5 Billion
SG&A as a percent of non-GAAP Net Revenues is expected to be ~25% reflecting plans to restructure and simplify the business following the divestiture of the Global Generics business to Teva
Non-GAAP tax rate anticipated to return to normalized levels following the close of Teva of ~14%
1 Excluding Namenda IR, divestitures and Anda.

Share Repurchase Program
Allergan reported that the Company’s board of directors has authorized a new share repurchase program of up to $10 billion of the Company’s common stock. Allergan expects to execute $4 – $5 billion in open market repurchases over four to six months subject to favorable market conditions. If favorable market conditions persist, the Company will consider extending the program following completion of the initial portion of the share repurchase program.

The share repurchase program is pending the completion of and receipt of proceeds from the divestiture of Allergan’s Global Generics business to Teva, expected to close by the end of June 2016.

First-Quarter 2016 Conference Call and Webcast Details
Allergan will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss first quarter 2016 results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 94452083. To access the live webcast, go to Allergan’s Investor Relations Web site at View Source

A taped replay of the conference call will also be available beginning approximately two hours after the call’s conclusion and will remain available through 11:30 PM Eastern Time on May 24, 2016. The replay may be accessed by dialing (855) 859-2056 and entering conference ID 94452083. From international locations, the replay may be accessed by dialing (404) 537-3406 and entering the same conference ID. To access the webcast, go to Allergan’s Investor Relations Web site at View Source A replay of the webcast will also be available.