0001104659-15-070270.txt : 20151013 0001104659-15-070270.hdr.sgml : 20151012 20151013080947 ACCESSION NUMBER: 0001104659-15-070270 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20151013 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151013 DATE AS OF CHANGE: 20151013 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LANNETT CO INC CENTRAL INDEX KEY: 0000057725 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 230787699 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31298 FILM NUMBER: 151154629 BUSINESS ADDRESS: STREET 1: 9000 STATE RD CITY: PHILADELPHIA STATE: PA ZIP: 19136 BUSINESS PHONE: 2153339000 MAIL ADDRESS: STREET 1: 9000 STATE ROAD STREET 2: 9000 STATE ROAD CITY: PHLADELPHIA STATE: PA ZIP: 19136 FORMER COMPANY: FORMER CONFORMED NAME: NETHERLANDS SECURITIES INC DATE OF NAME CHANGE: 19660629 8-K 1 a15-21025_18k.htm 8-K

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

 

Date of Report (Date of earliest event reported): October 13, 2015

 

LANNETT COMPANY, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Commission File No. 001-31298

 

State of Delaware

 

23-0787699

(State of Incorporation)

 

(I.R.S. Employer I.D. No.)

 

9000 State Road

Philadelphia, PA 19136

(215) 333-9000

(Address of principal executive offices and telephone number)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o                 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

ITEM 7.01 REGULATION FD DISCLOSURE

 

In connection with Lannett Company Inc.’s (“Lannett”) pending private financing transaction related to the pending acquisition of Kremers Urban Pharmaceuticals Inc. (“KUPI”), Lannett anticipates disclosing to prospective financing sources certain historical financial and other information with respect to Lannett and KUPI that has not been previously publicly reported. This information is attached hereto as Exhibits 99.1, 99.2 and 99.3 and incorporated by reference herein.

 

The information disclosed under this Item 7.01, including Exhibits 99.1, 99.2 and 99.3 and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

 

(d)        Exhibits

 

99.1     Kremers Urban Pharmaceuticals Inc. Business Overview

99.2     Kremers Urban Pharmaceuticals Inc. Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ending June 30, 2015 and 2014 and the years ending December 31, 2014, 2013 and 2012

99.3     Lannett Company, Inc. and Kremers Urban Pharmaceuticals Inc. key product revenues by period and certain market information

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

 

LANNETT COMPANY, INC

 

 

 

By:

/s/ Arthur P. Bedrosian

 

 

Chief Executive Officer

 

 

Date: October 13, 2015

 

 

2



 

EXHIBIT INDEX

 

Exhibit:

 

Description:

 

 

 

99.1

 

Kremers Urban Pharmaceuticals Inc. Business Overview

99.2

 

Kremers Urban Pharmaceuticals Inc. Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ending June 30, 2015 and 2014 and the years ending December 31, 2014 and 2013

99.3

 

Lannett Company, Inc. and Kremers Urban Pharmaceuticals Inc. key product revenues by period and certain market information

 

3


EX-99.1 2 a15-21025_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Kremers Urban Pharmaceuticals Inc.’s (“KUPI”) Business

 

Business Overview

 

KUPI is an integrated specialty generics company, focused on the development, manufacture and commercialization of complex pharmaceutical products.  KUPI’s diverse portfolio of marketed and pipeline products addresses both sizable and niche market opportunities.

 

As of June 30, 2015, KUPI manufactured and/or distributed 18 marketed products in a variety of dosage forms including tablets, capsules, suspensions and powders, including six products each generating in excess of $20 million in net sales annually in the twelve months ended June 30, 2015. KUPI’s pipeline portfolio includes 28 products in various stages of development, including one 505(b)(2) product. There are 11 ANDA filings that are pending U.S. Food and Drug Administration (“FDA”) approval, including five products containing Paragraph IV certifications. KUPI has deep expertise in the development of challenging formulations, which supports its development strategy of targeting specialty products and sustainable markets. KUPI also has extensive experience in the development and manufacture of controlled substances (each, a “CII Product”), which by regulation are required to be manufactured in the United States and require special handling and storage procedures. Highlighting KUPI’s R&D strategy, 11 generic products currently in development have been, or are expected to be submitted to the FDA containing Paragraph IV certifications.

 

KUPI currently has corporate offices in Princeton, New Jersey and manufacturing and research facilities in Seymour, Indiana. The Princeton corporate office houses executive functions, strategic planning, business development, R&D senior management, finance, sales and marketing, and legal administration, while the Seymour facility manufactures over 98% of the oral solids that KUPI markets and distributes. Seymour underwent an FDA inspection in 2014 and an European Medicines Agency, or EMA, inspection in 2015 and, since its acquisition by UCB in 2007, KUPI has not received any FDA Warning Letters resulting from Form 483 observations. In addition, KUPI has historically manufactured products for various third parties, including several notable global pharmaceutical companies, under standard Contract Manufacturing Organization (“CMO”) agreements. For the twelve months ended June 30, 2015, KUPI’s net sales from contract manufacturing, including sales to related parties, totaled approximately $52.5 million. In addition to manufacturing, the Seymour operations also include packaging, warehousing, R&D operations, regulatory, quality management, information technology (“IT”), accounting and human resource capabilities.

 

For the twelve months ended June 30, 2015, KUPI realized net sales of $412.7 million and Adjusted EBITDA of approximately $142.4 million.

 

Business Strategies

 

KUPI’s vision is to be a premier specialty generic pharmaceutical company that provides value to both its customers and major stakeholders. To accomplish this vision, KUPI has embraced a strategy of focusing on modified release oral solid dosage products, and by diversifying its portfolio by adding injectable, transdermal, and inhalation products.

 

Key Products

 

Methylphenidate Hydrochloride Extended Release Tablets (“Methylphenidate ER”)

 

Methylphenidate ER is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (“ADHD”) in children six years of age and older, adolescents, and adults up to the age of 65. The product is a generic version of the branded drug Concerta®, which is currently marketed by Johnson & Johnson, and competes with a generic product marketed by Mallinckrodt Pharmaceuticals and an Authorized Generic (“AG”) marketed by Actavis. KUPI’s product was approved by the FDA in 2013 with a therapeutic equivalence rating of AB, meaning the FDA deemed it therapeutically equivalent to the brand-name drug, Concerta®.

 

In November 2014, the FDA asked KUPI to conduct new bioequivalence testing of its Methylphenidate ER product using the FDA’s newly revised bioequivalence criteria or to voluntarily withdraw the product from the

 



 

market. The FDA concurrently made the same request to the other non-AG competitor (Mallinckrodt) regarding its Methylphenidate product. The FDA also changed the therapeutic equivalence rating for KUPI’s and Mallinckrodt’s product from AB to BX at such time. A product that is BX-rated is still approved and can be dispensed, but it may not be automatically substitutable at the pharmacy for the brand-name drug under certain state laws. The FDA explained that while there were no safety or efficacy concerns, an FDA internal analysis (based on reports of lack of effect and differences in pharmacokinetic (“PK”) profiles and delivery systems) suggested that KUPI’s generic Methylphenidate ER product may not be therapeutically equivalent to Concerta. In June 2015, KUPI submitted the final results of new bioequivalence studies designed to assess whether KU’s Methylphenidate ER product meets the FDA’s proposed revised bioequivalence criteria. KUPI continues to market Methylphenidate ER under the BX rating and is in ongoing discussions with the FDA about the product.

 

The FDA has not indicated when it will reach a decision on whether to revise the bioequivalence rating of Methylphenidate ER, and no assurance can be made that any such decision will result in Methylphenidate ER’s AB rating being restored. If the FDA should decide to retain the BX rating of Methylphenidate ER, KUPI will have to continue marketing the drug under its current rating.  In addition, if KUPI is unable to regain an AB therapeutic rating, there is no assurance that the FDA will allow KUPI to retain the BX rating over the longer term.  This could result in KUPI having to potentially reformulate Methylphenidate ER or otherwise discontinue sales.

 

For the twelve months ended June 30, 2015, net sales from Methylphenidate ER were $104.3 million. For the six months ended June 30, 2015, which reflects a full period of sales under the BX rating, net sales from Methylphenidate ER were $36.5 million. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number three position in the generic market with approximately 17% share.

 

Omeprazole DR Capsules

 

Omeprazole DR is a proton pump inhibitor that decreases the amount of acid produced in the stomach. The product is a generic version of the branded drug Prilosec®. It is indicated for heartburn or irritation of the esophagus caused by gastroesophageal reflux disease.  KUPI produces Omeprazole DR capsules in 10mg, 20mg and 40mg dosages. For the twelve months ended June 30, 2015, Omeprazole DR net sales were $59.1 million. In distributing this product, KUPI competes primarily with Sandoz, Dr. Reddy’s and Zydus.  As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number two position in the generic market with approximately 20% share.

 

Oxybutynin Chloride ER Tablets

 

Oxybutynin Chloride ER is an antispasmodic, anticholinergic agent. The product is indicated for the treatment of overactive bladder with symptoms of urgent urinary incontinence and frequency. Oxybutynin Chloride ER is produced by KUPI in 5mg, 10mg and 15mg tablet dosage forms. KUPI sells this product in 115 ml (4 oz.) liquid suspension dosage forms.  For the twelve months ended June 30, 2015, Oxybutynin Chloride ER net sales were $37.5 million. KUPI competes primarily with Mylan and Teva in this market. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number two position in the generic market with approximately 43% share.

 

Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic® (Tussionex AG)

 

Tussionex AG is a centrally-acting, narcotic antitussive combined with an antihistamine. The product is indicated for relief of cough and upper respiratory symptoms associated with an allergy or a cold. KUPI launched Tussionex AG as a 4oz unit of use as UCB’s AG. The product was designated as a Schedule II controlled substance  in October 2014, which requires that API and finished dosage be manufactured in the United States. KUPI sells this product in 115 ml (4 oz.) liquid suspension dosage forms. For the twelve months ended June 30, 2015, Tussionex AG net sales were $24.0 million. KUPI competes primarily with Par Pharmaceutical and Neos Therapeutics. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number one position in the generic market with approximately 51% share.

 

Methylphenidate CD (Metadate CD AG) Capsules

 

Methylphenidate CD is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and was launched as UCB’s AG for Metadate CD. As an extended release Schedule II

 



 

controlled substance, the API and finished dosage must be manufactured in the United States.  KUPI sells Methylphenidate CD in 10mg, 20mg, 40mg, 50mg and 60mg dosage forms. For the twelve months ended June 30, 2015, Methylphenidate CD net sales were $20.1 million. KUPI competes primarily with Teva. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number one position in the generic market with approximately 53% share.

 

Nifedipine ER Tablets

 

Nifedipine ER is a calcium ion influx inhibitor, slow-channel blocker or calcium ion antagonist. The product is indicated for management of vasospastic angina, chronic stable angina and for the treatment of hypertension. This product is sold by KUPI in 30mg, 60mg and 90mg tablet dosage forms.  For the twelve months ended June 30, 2015, Nifedipine ER net sales were $18.9 million. KUPI competes primarily with Mylan, Teva and Greenstone. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number two position in the generic market with approximately 16% share.

 

Pantoprazole Tablets

 

Pantoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. The product is indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. KUPI produces Pantoprazole in 20mg and 40mg dosage forms. For the twelve months ended June 30, 2015, Pantoprazole net sales were $22.2 million. KUPI competes primarily with Teva, Torrent and Mylan. As of August 31, 2015, based upon IMS last 12 month average data, KUPI’s product maintains a number three position in the generic market with approximately 13% share.

 

Validated Pharmaceutical Capabilities

 

KUPI’s 300,000 square foot Seymour, Indiana facility contains approximately 107,000 square feet of manufacturing space. Seymour has had satisfactory inspections conducted by the FDA and EMA and similar regulatory authorities of Japan, Taiwan, Brazil, Korea and Turkey. Since 2008, KUPI has invested more than $75 million into improvements to the facility and new equipment. This investment enabled the facility to increase production from approximately 1.2 billion doses in 2008 to over 2.7 billion doses in 2014. KUPI recently completed a $20 million 20,000 square foot expansion of the facility which, in combination with an additional planned expansion in 2016, is expected to increase capacity to 3.9 billion doses by 2017. The facility also includes four packaging lines, one of which is a high speed line added in 2012.

 

In addition to the 20,000 square foot expansion completed in 2014, KUPI entered into a ten-year lease of a temperature/humidity-controlled 116,000 square foot warehouse adjacent to the Seymour facility for increased storage capacity. Construction of the new leased warehouse was completed during October 2015 and will provide KUPI with the additional storage capacity needed to support planned growth while eliminating the use of less efficient third party warehousing. KUPI added a large vault for storing controlled substances in 2011 and is also planning to expand its CII vault capabilities in conformance with DEA requirements.

 

The Seymour site has the potential for significant additional expansion of the facility’s footprint. KUPI has strong relationships with local authorities and has had no issues securing the necessary authorizations to expand the facility in the past.

 

The Seymour facility is in good standing with all U.S. regulatory authorities, including the FDA, DEA, U.S. Environmental Protection Agency, Occupational Safety and Health Administration, Equal Employment Opportunity Commission and state pharmacy boards, as well as various international regulatory authorities including the EMA.

 

Research and Development

 

In 2011, KUPI completed building out its internal development capabilities, with the opening of a 22,500 square foot R&D facility in its state-of-the-art plant in Seymour, Indiana. Before this time, KUPI relied primarily on external partners to source its pipeline. The R&D team is currently comprised of nine people and supported by an analytical team. The R&D group includes three formulation teams and one Associate Director of Biopharmaceutics.

 



 

KUPI’s R&D efforts focus on niche oral solids, including products with difficult formulations and specialized delivery technologies. While KUPI has historically sourced pipeline products from in-house development, co-development, and in-licensing, going forward KUPI has a target of sourcing approximately 65-70% of its products from internal development. Internally developed products are not subject to royalty obligations owed to external development partners and therefore have the potential for higher levels of profitability. KUPI expects to selectively enter into new external development deals for products that satisfy internal profitability and other requirements.

 

Sales and Customer Relationships

 

Generic Pharmaceutical Sales

 

KUPI believes that it has strong relationships with all of its strategic customers as a result of experienced account management, high quality service levels and strong operational follow-up. KUPI’s customers include the largest Tier 1 and 2 wholesalers, retail/mail order pharmacies, buying groups, government and non-profit organizations. Within channels, KUPI makes strategic decisions and targets customers based on product landscape, competition and target market share.

 

Among wholesalers, KUPI has focused on developing business with McKesson (which is now inclusive of Rite Aid), AmerisourceBergen and Cardinal and has seen constant growth from 2009 through 2014. KUPI also has established relationships with regards to the Tier 2 distributors. Over the last five years, KUPI has developed solid positions with retail pharmacies, which include Walgreens, CVS and Wal-Mart. KUPI has also developed relationships with Red Oak, the buying group for Cardinal and CVS, and Walgreens Boots Alliance, the buying group for AmerisourceBergen and Walgreens. Additionally, the growth of the group purchasing organization operated by Econdisc, which is comprised of Express Script, Medco and Kroger, has generated incremental growth since 2012. KUPI also has a strategic focus on government business and has solid performance in that segment.

 

Third Party Manufacturing

 

As part of its business, KUPI also manufactures products for various third parties, including UCB through intercompany agreements. Since 2008, additional third party business has been considered only if it was requested by the existing base of third party customers. This change helped redirect excess capacity towards the growth of KUPI’s generics business. Third party products produced by KUPI are sold in the United States, European Union, China and other countries. KUPI manufactures these products for third parties through standard CMO agreements. The supply agreements for this sector of business, typically multiyear contracts, allow KUPI to adequately plan its long-term production capacities and profit forecasts.

 

Customers for KUPI’s third party manufacturing business includes several notable global pharmaceutical companies, including Genentech Inc., a subsidiary of Roche Holding AG, Arbor Pharmaceuticals, Inc., Recro Pharma and UCB.

 

Current Products

 

As of the date of this filing, KUPI manufactures, markets and/or distributes the following products under the KUPI label:

 

Name of Product(1)

 

Medical Indication

 

Equivalent Brand

1

 

Omeprazole DR

 

Gastrointestinal

 

Prilosec®

2

 

Oxybutynin ER

 

Urinary

 

Ditropan XL®

3

 

Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic® (AG)

 

Respiratory

 

Tussionex® CII

4

 

Nifedipine XL

 

Cardiovascular

 

Procardia XL®

5

 

Pantoprazole DR

 

Gastrointestinal

 

Protonix®

6

 

Methylphenidate CD (AG)

 

CNS

 

Metadate® CD™

7

 

Isosorbide Mononitrate ER

 

Cardiovascular

 

Imdur®

 



 

8

 

Glycolax Rx

 

Gastrointestinal

 

MiraLAX® Rx

9

 

Montelukast IR/Chewable

 

Respiratory

 

Singulair®

10

 

Rabeprazole

 

Gastrointestinal

 

AcipHex®

11

 

Atorvastatin

 

Cardiovascular

 

Lipitor®

12

 

Verapamil DR (AG)

 

Cardiovascular

 

Verelan PM®

13

 

Polyethylene Glycol 3350 (AG)

 

Gastrointestinal

 

CoLyte®

14

 

Verelan®/Verelan®PM

 

Cardiovascular

 

N/A

15

 

Glycolax OTC

 

Gastrointestinal

 

MiraLAX® OTC

16

 

Tacrolimus

 

Organ Rejection

 

Prograf®

17

 

Nitroglycerin TD (Discontinued)

 

Cardiovascular

 

Nitro-Dur®

18

 

Methylphenidate ER

 

CNS

 

Concerta®

 

Raw Materials and Finished Goods Suppliers

 

The raw materials for KUPI’s products are primarily APIs, which are currently purchased from specialized API manufacturers. Other raw materials are common pharmaceutical excipients and packaging components, which are readily available. KUPI emphasizes strong working relationships with its key suppliers, which we believe have a reputation for quality and customer service, and KUPI has generally not had any difficulty in obtaining raw materials. KUPI has also put contingency plans in place, including several contracts with alternative suppliers of APIs, to minimize the potential for supply shortages.

 

KUPI utilizes third parties for manufacturing and/or packaging of certain products including Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic® (AG), Methylphenidate CD (AG), Tacrolimus, Verapamil DR (AG) and Verelan®/Verelan®PM.

 

Competition

 

The manufacturing, marketing and distribution of generic pharmaceutical products is a highly competitive industry. Competition is based on many factors including price, ability to supply and customer service. KUPI’s competitive advantages include its diversified portfolio of products, robust pipeline and R&D capabilities, distinguished sales and marketing capabilities, strategic manufacturing operations, strong legal and regulatory capabilities, and experienced management team.

 

KUPI competes with other manufacturers and marketers of generic and brand name drugs. Each product manufactured and/or sold by KUPI has a different set of competitors. The list below identifies the companies with which KUPI primarily competes with respect to each of its major products.

 

Product

 

Primary Competitors

 

 

 

Omeprazole DR

 

Sandoz, Dr. Reddy’s, Zydus

 

 

 

Oxybutynin ER

 

Mylan, Teva

 

 

 

Methylphenidate ER

 

Actavis, Mallinckrodt

 

 

 

Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic® (AG)

 

Par, Neos Therapeutics

 

 

 

Methylphenidate CD (Metadate CD AG)

 

Teva

 

 

 

Nifedipine XL

 

Mylan, Teva, Greenstone

 

 

 

Pantoprazole DR

 

Teva, Torrent, Mylan

 



 

Certain of KUPI’s current and potential competitors have greater resources, longer histories, more customers, and greater name recognition than KUPI. They may secure better terms from suppliers, adopt more aggressive pricing, and devote more resources to technology, infrastructure, R&D, sales and marketing. Other companies also may enter into business combinations or alliances that strengthen their competitive positions.  If one or more other generic pharmaceutical manufacturers significantly reduce their prices in an effort to gain market share, KUPI’s profitability or market position could be adversely affected.

 

Government Regulations

 

Similar to Lannett, KUPI is subject to a significant amount of government regulation. For a description of the various government regulations that KUPI is subject to, see “Government Regulation” under the description of Lannett’s business in Lannett’s Annual Report on Form 10-K for the fiscal year ended June 30, 2015.

 

Employees

 

As of September 30, 2015, KUPI had 672 employees. There are no KUPI employees who are represented by a collective bargaining agreement.

 



 

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

 

KUPI

 

KUPI has sales to and purchases from various affiliates of UCB. Total net sales to various UCB entities were approximately $12.3 million and $11.0 million for the six months ended June 30, 2015 and 2014, respectively, and approximately $18.8 million, $10.7 million and $9.6 million during the years ended December 31, 2014, 2013 and 2012, respectively. Purchases of products from UCB affiliated entities were approximately $15.5 million and $25.6 million for the six months ended June 30, 2015 and 2014, respectively, and $47.9 million, $52.2 million and $40.3 million for the years ended December 31, 2014, 2013 and 2012, respectively. KUPI also receives services and support from UCB for various functions and KUPI’s operations have been dependent upon UCB’s ability to perform these services and support functions. For a period of time after closing of the Acquisition, UCB will continue to provide these services to KUPI pursuant to a Transitional Services Agreement entered into between UCB and KUPI upon closing of the Acquisition.

 

In addition, KUPI participates in cash pooling and financing arrangements with UCB. Under these arrangements, KUPI pays or receives interest, at a rate commensurate with market pricing for short-term borrowings or deposits, based on accounts payable to or receivable from UCB.

 

For additional information, see Note 13 to Kremer’s unaudited condensed consolidated financial statements for the six months ended June 30, 2015 and Note 14 to KUPI’s audited consolidated financial statements for the year ended December 31, 2014, which are contained elsewhere/incorporated by reference in this memorandum.

 


EX-99.2 3 a15-21025_1ex99d2.htm EX-99.2

Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OF KUPI

 

The following information should be read in conjunction with the consolidated financial statements and notes thereto of Kremers Urban Pharmaceuticals Inc. (herein referred to as “KUPI”).

 

In addition to historical information, the following discussion and analysis contains forward-looking information.  The forward-looking information is subject to certain risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements.  Important factors that might cause such a difference include, but are not limited to, those discussed in the following section, entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations of KUPI” and under “Risk Factors” and contained elsewhere in this offering memorandum.  Readers are cautioned not to place undue reliance on these forward-looking statements.  Neither Lannett Company, Inc. nor KUPI undertake any obligation to revise or update these forward-looking statements to reflect events or circumstances that may occur.  Financial information included herein has been rounded for the convenience of presentation.

 

KUPI Overview

 

KUPI is an integrated specialty generic pharmaceutical company, focused on the development, manufacture and commercialization of products that are difficult to formulate or utilize specialized delivery technologies. As of June 30, 2015, KUPI manufactured and/or distributed 18 marketed products in a variety of dosage forms including tablets, capsules, suspensions and powders, including six products each generating in excess of $20 million in revenue annually. KUPI currently has 11 filed ANDAs under review with the FDA, including five products containing Paragraph IV certifications, as well as 17 additional pipeline products in various stages of development. KUPI’s history dates back to its founding over 100 years ago. In 2007, KUPI was acquired by UCB as part of UCB’s purchase of Schwarz Pharma AG.

 

KUPI manufactures nearly all of its products at its approximately 300,000 square foot manufacturing facility with an annual capacity of 3.2 billion doses.  KUPI leases an additional 116,000 square foot warehouse facility.  Both facilities are located in Seymour, Indiana.  The Seymour facility underwent an FDA inspection in 2014 and an EMA inspection in 2015 and, since its acquisition by UCB in 2007, KUPI has not received any FDA Warning Letters resulting from Form 483 observations. In addition, KUPI has historically manufactured products for various third parties, including several notable global pharmaceutical companies, under standard CMO agreements.

 

Certain Factors Impacting KUPI’s Performance and Financial Results

 

KUPI’s future profitability depends on several factors, including KUPI’s ability to increase revenues through sales and marketing activities, the continued market and regulatory acceptance of KUPI’s products and its ability to continue to enhance existing products and develop or acquire new products that meet patients’ needs and preferences.

 

Product development and improvements require investments of significant financial, technological and other resources in existing and new products. In addition, they require significant planning, design, development and testing at the technological, product and manufacturing process levels, and KUPI may not be able to timely or cost-effectively develop new products or improve existing products. Likewise, KUPI may not be able to acquire new products on terms that are acceptable to it, or at all.

 

KUPI’s success also depends on the ability to manage manufacturing costs, including raw material costs, and manufacture products that meet applicable regulatory and commercial requirements and, where applicable, to maintain regulatory approvals for KUPI’s existing products and secure regulatory approvals for new products. The need to obtain and maintain regulatory approvals in order to market and sell products may limit KUPI’s ability to act quickly in scaling commercialization.

 



 

Methylphenidate Hydrochloride Extended Release Tablets (“Methylphenidate ER”)

 

KUPI’s Methylphenidate ER product represents a significant portion of KUPI’s net sales, net income and cash flows.

 

Methylphenidate ER is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (“ADHD”) in children six years of age and older, adolescents, and adults up to the age of 65. The product is a generic version of the branded drug Concerta®, which is currently marketed by Johnson & Johnson, and competes with two other generic products marketed by Mallinckrodt Pharmaceuticals and an Authorized Generic (“AG”) marketed by Actavis. KUPI’s product was approved by the FDA in 2013 with an AB rating, meaning the FDA deemed it therapeutically equivalent to the brand-name drug, Concerta®.

 

During a teleconference in November 2014, the U.S. Food and Drug Administration (“FDA”) informed KUPI that it had concerns about whether generic versions of Concerta® (methylphenidate hydrochloride extended release tablets), including KUPI’s Methylphenidate ER product, are therapeutically equivalent to Concerta®.  FDA indicated that its concerns were based in part on adverse event reports concerning lack of effect and its analyses of pharmacokinetic data.  FDA informed KUPI that it was changing the therapeutic equivalence rating of its product from “AB” (therapeutically equivalent) to “BX.”  A BX-rated drug is a product for which the data are insufficient to determine therapeutic equivalence; it is still approved and can be dispensed, but it may not be automatically substitutable at the pharmacy for the brand name drug under certain state laws.  The FDA has indicated that there are no safety issues with KUPI’s product.

 

During the November 2014 teleconference, FDA also asked KUPI to either voluntarily withdraw its product or to conduct new bioequivalence (BE) testing in accordance with the recommendations for demonstrating bioequivalence to Concerta proposed in a new draft BE guidance that FDA issued earlier in November.  FDA had approved the KUPI product (and originally granted it an AB rating) in 2013, on the basis of KUPI data showing its product met bioequivalence criteria set forth in draft bioequivalence guidance that FDA had issued in 2012.  FDA’s position concerning the KUPI product was the subject of a public announcement by the agency. KUPI agreed to conduct new bioequivalence studies per the new draft bioequivalence guidance.  KUPI submitted the data from those studies to FDA in June 2015 and is in ongoing discussions with the FDA about the product.

 

Components of Results of Operations

 

Net Revenues

 

KUPI generates net sales primarily through the sale of products in the United States to wholesaler/distributor chains, retail chains, mail-order pharmacies and through third party contract manufacturing.  KUPI’s net sales are derived from sales of products in the following categories: Cardiovascular, Central Nervous Systems, Gastrointestinal, Respiratory and Urinary.  In addition, KUPI has also historically derived sales from manufacturing products for various third parties, including UCB.

 

Cost of Goods Sold

 

KUPI manufactures primarily all of its products at its manufacturing facility, an approximately 300,000 square foot facility with annual capacity of 3.2 billion doses, located in Seymour, Indiana.  Additionally, KUPI leases an 116,000 square foot warehouse facility, also located in Seymour, Indiana.  Both facilities are located in Seymour, Indiana.   Cost of goods sold includes direct production costs, direct production labor, related production overhead and royalty expenses.  Manufacturing overhead includes expenses for regulatory affairs, quality assurance, manufacturing engineering, material procurement, inventory control, facilities, equipment, operations supervision and management.  Royalty expenses relate primarily to KUPI’s use of intellectual property (IP) owned by unrelated third parties in the manufacturing and sale of KUPI’s products or services.  These expenses are recognized upon sale of the product to which the IP relates. KUPI has various royalty agreements which are primarily based upon a specified percentage of gross profit in accordance with the terms of the applicable agreement. Such amounts are settled in cash on a quarterly basis.

 



 

Gross Profit

 

KUPI expects gross profit, which is calculated as total net revenues less cost of goods sold for a given period, to fluctuate in future periods as a result of several factors, including the changing mix of products sold with different gross margins, changing percentage of products sold to wholesaler/distributors versus directly to retail chain and mail-order pharmacy customers, changes in KUPI’s manufacturing processes or costs and increased manufacturing output.  Any new products that KUPI sells in the future may change gross profit.  KUPI has experienced lower gross profit as a percentage of net sales due to the loss of the Methylphenidate ER AB rating in November 2014, as described below.  If the FDA reinstates the Methylphenidate ER AB rating KUPI gross profit as a percentage of total net revenues may or may not return to previous AB-rated levels, depending on competitors and other market conditions.

 

Research and Development Expenses

 

Research and development (“R&D”) costs are expensed as incurred and consist of self-funded R&D costs including internal labor, materials and biostudies as well as costs associated with work performed under collaborative R&D agreements.  Payments made at the inception of collaborative R&D agreements for future costs are capitalized and amortized over the estimated development period.  Subsequent payments under these agreements for the successful completion of certain stages or steps in the development process, also known as milestones, are expensed when the work has been successfully completed.  Due to the long development periods and significant uncertainties related to the development of new products (such as the risks related to the outcome of biostudies as well as the likelihood of regulatory approval), KUPI’s internal development costs do not qualify for capitalization as intangible assets.  KUPI expects R&D expenses to increase modestly, as increases in expenses related to developing, enhancing and commercializing new products and technologies will be only partially offset by the timing and extent of expenses relating to bioequivalence studies. KUPI expects R&D expenses as a percentage of revenue to vary over time depending on the level and timing of initiating new product development efforts.

 

Selling, General and Administrative Expenses:

 

Selling, general and administrative expenses consist primarily of compensation for personnel, including base salaries and bonus compensation and stock-based compensation, along with spending related to finance, information technology, and human resource functions. Other general and administrative expenses include travel expenses, professional services fees, audit fees, insurance costs and general corporate expenses, including allocated facilities-related expenses.  KUPI also records shipping and handling costs in selling, general and administrative expenses.

 

Historically, KUPI has received services and support from various functions performed by UCB, and costs associated with these functions have been allocated to KUPI based on headcount or using specific identification, including costs for information technology, corporate administration expenses, finance, legal, tax, treasury and other corporate services.  KUPI expects Selling, general and administrative expenses to continue to increase in absolute dollars as KUPI expands its commercial infrastructure to both drive and support planned growth in revenue.

 

Other Operating Expenses, Net

 

Other operating expenses, net, primarily relate to costs incurred associated with UCB’s planned divestiture of KUPI.

 

Provision for Income Taxes

 

KUPI is included in the UCB Holdings, Inc. consolidated U.S. federal income tax return and certain consolidated state income tax returns.  It also files numerous separate income tax returns in the U.S.  KUPI has determined its U.S. federal and state income tax provisions as if it were filing separate tax returns.  Given KUPI migrated management and control of its non U.S. subsidiary, Kudco Ireland Limited, a limited liability company organized under the laws of Ireland, to the U.S. on January 1, 2014, no foreign income taxes are reported for the year ended December 31, 2014.

 



 

Accrued U.S. federal, state and foreign current income tax balances, including interest, are treated as being settled without payment as of the end of each year with UCB Holdings, Inc.  Therefore, the settlement of the current income tax liability without payment is treated as a contribution from UCB Holdings, Inc. and is included in Payable to (receivable from) Parent in the Consolidated Statements of Stockholder’s Equity.  Cash income taxes paid in the Consolidated Statements of Cash Flows consists of the current federal provision settled through Payable to (receivable from) Parent and actual cash payments to states and foreign governments for income taxes.

 

Deferred income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income in the period that includes the enactment date of the rate change.  KUPI records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized.  KUPI has considered future taxable income and ongoing feasible tax planning strategies in assessing the need for a valuation allowance.  KUPI also records uncertain tax positions using a two-step process:  (1) it determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, it recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.

 



 

Results of Operations - Six months ended June 30, 2015 compared with the six months ended June 30, 2014

 

The following table sets forth KUPI’s results of operations for the six months ended June 30, 2015 compared to the six months ended June 30, 2014. This data should be read together with KUPI’s unaudited, interim condensed consolidated financial statements and related notes included elsewhere in this offering memorandum, and is qualified in its entirety by reference to such financial statements and related notes.

 

 

 

Six Months Ended

 

(In thousands)

 

June 30, 2015

 

June 30, 2014

 

Statement of Operations Data

 

 

 

 

 

Net sales

 

$

163,369

 

$

214,301

 

Net sales to related party

 

12,316

 

10,983

 

Contract manufacturing revenue

 

15,849

 

16,589

 

Total net revenues

 

 

191,534

 

 

241,873

 

Cost of goods sold

 

98,065

 

107,817

 

Cost of goods sold to related party

 

4,810

 

4,176

 

Contract manufacturing costs

 

9,160

 

8,317

 

Total cost of goods sold

 

112,035

 

120,310

 

Gross profit

 

79,499

 

121,563

 

Selling, general and administrative expenses

 

12,193

 

12,113

 

Selling, general and administrative expenses to related party

 

2,588

 

2,513

 

Research and product development costs

 

17,229

 

10,422

 

Other expenses, net

 

1,966

 

572

 

Total operating expenses

 

33,976

 

25,620

 

Income before provision for income taxes

 

45,523

 

95,943

 

Provision for income taxes

 

17,002

 

34,701

 

Net income and other comprehensive income

 

$

28,521

 

$

61,242

 

 

Total Net Revenues

 

Total net revenues decreased to $191.5 million, representing a 21% decline over the prior year, as further described below.

 

Net Sales by Product Medical Indication

 

The following table identifies KUPI’s net sales by product medical indication for the six months ended June 30, 2015 and 2014:

 

(In thousands)

 

Six Months Ended June 30,

 

Product Medical Indication

 

2015

 

2014

 

Cardiovascular

 

$

25,347

 

$

23,985

 

Central Nervous Systems

 

48,606

 

94,718

 

Gastrointestinal

 

54,284

 

52,458

 

Respiratory

 

14,405

 

22,127

 

Urinary

 

19,203

 

19,087

 

Other Products

 

869

 

1,019

 

Royalty Income

 

655

 

907

 

Total

 

$

163,369

 

$

214,301

 

 

Decreased volumes and product price decreases contributed $41.6 million and $9.1 million, respectively, to the overall decrease in net sales as compared to the prior year six month period. The decreased volumes primarily related to lower Methylphenidate ER sales as a result of the change in rating from AB to BX.  Net sales of Methylphenidate ER for the first six months of 2015 compared to the first six months of 2014 have decreased 56%.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

The following chart details price and volume changes by medical indication:

 



 

Product Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Cardiovascular

 

13

%

(7

)%

Central Nervous Systems

 

(44

)%

(5

)%

Gastrointestinal

 

4

%

(1

)%

Respiratory

 

(26

)%

(8

)%

Urinary

 

4

%

(4

)%

 

Cardiovascular.  Net sales of drugs used for cardiovascular treatment increased by $1.4 million, primarily as a result of increased volumes, partially offset by a decrease in average selling prices on key products.

 

Central Nervous Systems.  Net sales of drugs used for central nervous system treatment decreased $46.1 million.  The decrease in net sales was primarily attributable to decreased volumes of Methylphenidate ER, as noted above.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

Gastrointestinal.  Net sales of gastrointestinal products increased by $1.8 million.  The increase in net sales was attributable to volume increases on key products.

 

Respiratory.  Net sales of respiratory products decreased by $7.7 million.  The decrease in net sales was primarily attributable to volume decreases and to a lesser extent decreases in average selling prices.

 

Urinary.  Net sales of Oxybutynin ER were consistent with prior year as volume increases were offset by decreases in average selling prices.

 

KUPI sells its products to customers in various distribution channels.  The table below presents KUPI’s net sales to each distribution channel for the six months ended June 30, 2015 and 2014:

 

(In thousands)
Customer Distribution Channel

 

June 30,
2015

 

June 30,
2014

 

Wholesaler/Distributor

 

$

126,181

 

$

164,596

 

Retail Chain

 

27,209

 

38,039

 

Mail-Order Pharmacy

 

9,324

 

10,759

 

Royalty Income

 

655

 

907

 

Total

 

$

163,369

 

$

214,301

 

 

Net sales to wholesaler/distributor and retail chain decreased as a result of lower sales of Methylphenidate ER.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

Net Sales to Related Party.  Net sales to related party for the six months ended June 30, 2015 increased $1.3 million to $12.3 million.  The increase was primarily related to a product manufactured for UCB.

 

Contract Manufacturing Revenue.  Contract manufacturing revenues for the six months ended June 30, 2015 decreased $740 thousand to $15.8 million.  The decrease was primarily related to the timing of orders.

 

Cost of Goods Sold.  Cost of goods sold for the six months ended June 30, 2015 decreased $8.3 million to $112.0 million.  The decrease was primarily attributable to lower sales of Methylphenidate ER.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

Gross Profit.  Gross profit for the six months ended June 30, 2015 decreased 35% to $79.5 million, or 42% of total net revenues.  In comparison, gross profit for the six months ended June 30, 2014 was $121.6 million, or 50% of total net revenues.  The decrease in gross profit percentage for the six months ended June 30, 2015 was mainly attributable to lower sales of the higher-margin product Methylphenidate ER, which represented 22% of KUPI’s net product sales in the six months ended June 30, 2015 as compared to 39% of KUPI’s net product sales in the six months ended June 30, 2014.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 



 

Research and Development Expenses.  Research and development expenses for the first six months increased 65% to $17.2 million in the six months ended June 30, 2015 from $10.4 million in the six months ended June 30, 2014.  The increase was primarily due to the timing of bio-equivalency studies and development project material and supply expenses.

 

Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased 1% to $14.8 million in the six months ended June 30, 2015 compared with $14.6 million in the six months ended June 30, 2014.  The increase was primarily due to the higher fixed costs related to distribution and inflationary increases on services provided by UCB.

 

Other Operating Expenses, Net.  KUPI recorded other operating expense during the first six months ended June 30, 2015 totaling $2.0 million compared to other operating expenses totaling $572 thousand in the first six months ended June 30, 2014.  The increase was primarily related to costs associated with UCB’s planned divestiture of KUPI.

 

Provision for Income Taxes.  KUPI recorded income tax expense in the first six months of 2015 of $17.0 million compared to $34.7 million in the first six months of 2014.  The effective tax rate for the six months ended June 30, 2015 was 37% compared to 36% for the six months ended June 30, 2014.  The effective tax rate for the six months ended June 30, 2015 was higher compared to the six months ended June 30, 2014 primarily due to changes in estimates recorded upon KUPI’s determination of its current taxable income for the year ended December 31, 2014.

 

Net Income.  For the six months ended June 30, 2015, KUPI reported net income of $28.5 million.  Comparatively, net income in the prior year was $61.2 million.

 

Results of Operations — Year ended December 31, 2014 compared with the year ended December 31, 2013

 

The following table sets forth KUPI’s results of operations for year ended December 31, 2014 compared to the year ended December 31, 2013. This data should be read together with KUPI’s audited consolidated financial statements and related notes included elsewhere in this offering memorandum, and is qualified in its entirety by reference to such financial statements and related notes.

 

 

 

Year Ended

 

(In thousands)

 

December
31, 2014

 

December
31, 2013

 

Statement of Operations Data

 

 

 

 

 

Net sales

 

$

411,097

 

$

330,446

 

Net sales to related party

 

18,841

 

10,714

 

Contract manufacturing revenue

 

33,082

 

35,673

 

Total net revenues

 

463,020

 

376,833

 

Cost of goods sold

 

217,341

 

196,766

 

Cost of goods sold to related party

 

7,154

 

4,389

 

Contract manufacturing costs

 

17,790

 

19,589

 

Total cost of goods sold

 

242,285

 

220,744

 

Gross profit

 

220,735

 

156,089

 

Selling, general and administrative expenses

 

25,830

 

24,076

 

Selling, general and administrative expenses to related party

 

5,026

 

4,656

 

Research and product development costs

 

22,913

 

24,455

 

Other expenses, net

 

5,415

 

278

 

Total operating expenses

 

59,184

 

53,465

 

Income before provision for income taxes

 

161,551

 

102,624

 

Provision for income taxes

 

43,477

 

21,006

 

Net income

 

118,074

 

81,618

 

Other comprehensive income:

 

 

 

 

 

Foreign currency translation adjustment

 

 

841

 

Other comprehensive income

 

 

841

 

Comprehensive income

 

$

118,074

 

$

82,459

 

 



 

Total Net Revenues

 

Total net revenues increased to $463.0 million representing a 23% increase over the prior year, as further described below.

 

Net Sales by Product Medical Indication

 

The following table identifies KUPI’s net sales by product medical indication for the years ended December 31, 2014 and 2013:

 

(In thousands)

 

Year Ended December 31,

 

Product Medical Indication

 

2014

 

2013

 

Cardiovascular

 

$

51,590

 

$

50,786

 

Central Nervous System

 

170,497

 

85,074

 

Gastrointestinal

 

108,295

 

107,193

 

Respiratory

 

39,779

 

43,420

 

Urinary

 

37,361

 

39,180

 

Other Products

 

1,786

 

2,771

 

Royalty Income

 

1,789

 

2,022

 

Total

 

$

411,097

 

$

330,446

 

 

Increased volumes contributed $100.0 million to the overall increase in net product sales, partially offset by product price decreases of $19.1 million. The increase in volumes primarily related to higher Methylphenidate ER sales following launch in July 2013.  As a result of the change in rating from AB to BX in November 2014, net sales of Methylphenidate ER for the last six months of 2014 decreased 19% compared to the first six months of 2014.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

The following chart details price and volume changes by product medical indication:

 

Product Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Cardiovascular

 

3

%

(2

)%

Central Nervous System

 

102

%

(1

)%

Gastrointestinal

 

7

%

(6

)%

Respiratory

 

5

%

(13

)%

Urinary

 

6

%

(11

)%

 

Cardiovascular.  Net sales of drugs used for cardiovascular treatment increased by $804 thousand, primarily as a result of increased volumes, partially offset by decreases in average selling prices of products within the medical indication.

 

Central Nervous System.  Net sales of drugs used for central nervous system treatment increased by $85.4 million.  The increase in net sales was primarily attributable to a full year of net sales for Methylphenidate ER following the launch of the product in July 2013, as noted above.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

Gastrointestinal.  Net sales of gastrointestinal drugs increased by $1.1 million.  The increase in net sales was primarily attributable to increases in volumes, partially offset by price decreases.

 

Respiratory.  Net sales of respiratory drugs decreased by $3.6 million.  The decrease in net sales was primarily attributable to a decrease in average selling price on key products, partially offset by an increase in volumes.

 



 

Urinary.  Net sales of Oxybutynin ER decreased by $1.8 million due to a decrease in average selling price, partially offset by increased volumes.

 

KUPI sells its products to customers in various distribution channels.  The table below presents KUPI’s net sales to each distribution channel for the years ended December 31, 2014 and 2013:

 

(In thousands)
Customer Distribution Channel

 

December
31,
2014

 

December
31,
2013

 

Wholesaler/Distributor

 

$

318,819

 

$

213,100

 

Retail Chain

 

68,909

 

89,567

 

Mail-Order Pharmacy

 

21,580

 

25,757

 

Royalty Income

 

1,789

 

2,022

 

Total

 

$

411,097

 

$

330,446

 

 

Net sales to wholesaler/distributor increased as a result of increased sales in products for central nervous system, as discussed above.  Additionally, the increase in net sales to wholesaler/distributor was impacted by the strategic partnership between AmerisourceBergen and Walgreens, whereby AmerisourceBergen began product distribution on behalf of Walgreens in 2014.  Other strategic partnerships between industry wholesalers and retailers also impacted net sales to wholesaler/distributor and retail chain.  Mail-order pharmacy net sales decreased primarily as a result of decreased sales of gastrointestinal products, as discussed above.

 

Net Sales to Related Party.  Net sales to related parties for the year ended December 31, 2014 increased $8.1 million to $18.8 million.  The increase was primarily related to a product manufactured for UCB, which was building inventory in anticipation of a temporary shutdown of shipments to China due to the expiration of a Chinese drug import license.  KUPI expects sales to return to normal levels in the second half of 2016.

 

Contract Manufacturing Revenue.  Contract manufacturing revenues for the year ended December 31, 2014 decreased $2.6 million to $33.1 million.  The decrease was primarily related to declining volumes on two products with contracts ending in 2015.

 

Cost of Goods Sold.  Cost of goods sold for the year ended December 31, 2014 increased $21.5 million to $242.3 million.  The increase was primarily due to increased volumes across a number of medical indications as well as higher costs related to maintenance and repair spending.

 

Gross Profit.  Gross profit for the year ended December 31, 2014 increased 41% to $220.7 million or 48% of total net revenues.  In comparison, gross profit for the year ended December 31, 2013 was $156.1 million or 41% of total net revenues.  The change in gross profit percentage for the year ended December 31, 2014 was mainly attributable to a change in the product sales mix.  Sales of the high-margin product Methylphenidate ER represented 37% of net product sales in the year ended December 31, 2014 as compared to 18% of net product sales in the year ended December 31, 2013.  Refer to Methylphenidate ER information in “Certain Factors Impacting KUPI’s Performance and Financial Results” above.

 

Research and Development Expenses.  Research and development expenses decreased 6% to $22.9 million for the year ended December 31, 2014 compared to $24.5 million in the prior year period.  The decrease was primarily due to the timing of milestone expenses and other development project expenses.

 

Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased 7% to $30.9 million for the year ended December 31, 2014 compared with $28.7 million in the prior year period.  The increase was primarily due to compensation costs related to the planned sale of KUPI as well as higher distribution costs as a result of the higher sales volumes.

 

Other Operating Expense, Net.  KUPI recorded other operating expenses during the year ended December 31, 2014 totaling $5.4 million compared to other operating expenses totaling $278 thousand in the prior year period.  The increase was primarily due to costs associated with UCB’s planned divestiture of KUPI.

 



 

Provision for Income Taxes.  KUPI recorded income tax expense for the year ended December 31, 2014 of $43.5 million compared to $21.0 million for the year ended December 31, 2013.  The effective tax rate for the year ended December 31, 2014 was 27%, compared to 20% for the prior year period.  The increase in the effective tax rate in the year ended December 31, 2014 as compared to the year ended December 31, 2013 was due primarily to the reduced rate benefit associated with reversals of uncertain tax positions upon statutory expirations.

 

At December 31, 2014, KUPI had recognized a net deferred tax asset of $58.7 million.  KUPI has not recorded a valuation allowance against its deferred tax assets given it expects the net deferred tax assets to be fully realizable based on KUPI’s history of profitability and future expectations of taxable income.

 

Net Income.  For the year ended December 31, 2014, KUPI reported net income of $118.1 million.  Comparatively, net income in the prior year was $81.6 million for the year ended December 31, 2013.

 



 

Results of Operations — Year ended December 31, 2013 compared with the year ended December 31, 2012

 

The following table sets forth KUPI’s results of operations for year ended December 31, 2013 compared to the year ended December 31, 2012. This data should be read together with KUPI’s audited consolidated financial statements and related notes included elsewhere in this offering memorandum, and is qualified in its entirety by reference to such financial statements and related notes.

 

 

 

Year Ended

 

(In thousands)

 

December
31, 2013

 

December
31, 2012

 

Statement of Operations Data

 

 

 

 

 

Net sales

 

$

330,446

 

$

272,772

 

Net sales to related party

 

10,714

 

9,609

 

Contract manufacturing revenue

 

35,673

 

37,698

 

Total net revenues

 

376,833

 

320,079

 

Cost of goods sold

 

196,766

 

163,768

 

Cost of goods sold to related party

 

4,389

 

3,595

 

Contract manufacturing costs

 

19,589

 

23,315

 

Total cost of goods sold

 

220,744

 

190,678

 

Gross profit

 

156,089

 

129,401

 

Selling, general and administrative expenses

 

24,076

 

22,241

 

Selling, general and administrative expenses to related party

 

4,656

 

4,712

 

Research and product development costs

 

24,455

 

20,007

 

Other expenses, net

 

278

 

(752

)

Total operating expenses

 

53,465

 

46,208

 

Income before provision for income taxes

 

102,624

 

83,193

 

Provision for income taxes

 

21,006

 

16,538

 

Net income

 

81,618

 

66,655

 

Other comprehensive income:

 

 

 

 

 

Foreign currency translation adjustment

 

841

 

102

 

Other comprehensive income

 

841

 

102

 

Comprehensive income

 

$

82,459

 

$

66,757

 

 

Total Net Revenues

 

Total net revenues increased to $376.8 million representing an 18% increase over the prior year period, as described below.

 

Net sales by product medical indication

 

The following table identifies KUPI’s net sales by product medical indication for the years ended December 31, 2013 and 2012:

 

(In thousands)

 

Year Ended December 31,

 

Product Medical Indication

 

2013

 

2012

 

Cardiovascular

 

$

50,786

 

$

50,319

 

Central Nervous System

 

85,074

 

10,275

 

Gastrointestinal

 

107,193

 

126,655

 

Respiratory

 

43,420

 

43,073

 

Urinary

 

39,180

 

39,594

 

Other Products

 

2,771

 

317

 

Royalty Income

 

2,022

 

2,539

 

Total

 

$

330,446

 

$

272,772

 

 

Increased volumes contributed $124.2 million to the overall increase in net sales, partially offset by $66.0 million in price decreases.  The increase in volumes primarily related to higher Methylphenidate ER sales following the launch of the product in July 2013.

 



 

The following chart details price and volume changes by product medical indication:

 

Product Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Cardiovascular

 

12

%

(11

)%

Central Nervous System

 

760

%

(32

)%

Gastrointestinal

 

10

%

(26

)%

Respiratory

 

20

%

(19

)%

Urinary

 

30

%

(31

)%

 

Cardiovascular.  Net sales of drugs used for cardiovascular treatment increased by $467 thousand, primarily as a result of increased volumes, partially offset by decreases in average selling price of products within the medical indication.

 

Central Nervous System.  Net sales of drugs used for central nervous system treatment increased by $74.8 million.  The increase in net sales was primarily attributable to increased volumes of Methylphenidate ER following the launch of the product in July 2013.

 

Gastrointestinal.  Net sales of gastrointestinal drug products decreased by $19.5 million.  The decrease in net sales was primarily attributable to price decreases in key products, partially offset by increased volumes.

 

Respiratory.  Net sales of respiratory drug products increased by $347 thousand, primarily related to increased volumes, partially offset by a decrease in average selling price of products within the medical indication.

 

Urinary.  Net sales of Oxybutynin ER decreased by $414 thousand, primarily related to decreases in the average selling price, partially offset by increased volumes.

 

KUPI sells its products to customers in various distribution channels.  The table below presents KUPI’s net sales to each distribution channel for the years ended December 31, 2013 and 2012:

 

(In thousands)
Customer Distribution Channel

 

December
31,
2013

 

December
31,
2012

 

Wholesaler/Distributor

 

$

213,100

 

$

147,594

 

Retail Chain

 

89,567

 

87,505

 

Mail-Order Pharmacy

 

25,757

 

35,134

 

Royalty Income

 

2,022

 

2,539

 

Total

 

$

330,446

 

$

272,772

 

 

Net sales to wholesaler/distributor increased as a result of increased sales in a variety of products for central nervous system, as discussed above.  Mail-order pharmacy net sales decreased primarily as a result of decreased sales of gastrointestinal products, as discussed above.

 

Net Sales to Related Party.  Net sales to related party for the year ended December 31, 2013 increased $1.1 million to $10.7 million.  The increase was primarily related to higher sales volumes of a product manufactured for UCB.

 

Contract Manufacturing Revenue.  Contract manufacturing revenues for year ended December 31, 2013 decreased $2.0 million to $35.7 million.  The increase was primarily related to the timing of orders and lower demand across several products.

 

Cost of Goods Sold.  Cost of goods sold for the year ended December 31, 2013 increased $30.1 million to $220.7 million. The increase was primarily due to increased volumes across a number of medical indications as well as investments in quality control and quality assurance.

 



 

Gross Profit.  Gross profit for the year ended December 31, 2013 increased 21% to $156.1 million or 41% of total net revenues.  In comparison, gross profit for the year ended December 31, 2012 was $129.4 million or 40% of total net revenues.  The change in gross profit percentage for the year ended December 31, 2013 was mainly attributable to a change in the product sales mix.  Sales of the higher-margin products Metadate AG and Methylphenidate ER represented 26% of net product sales in the year ended December 31, 2013 as compared to 4% of net product sales in the year ended December 31, 2012.

 

Research and Development Expenses.  Research and development expenses increased 22% to $24.5 million for the year ended December 31, 2013 compared to $20.0 million in the prior year.  The increase was primarily due to the timing of product development material and supply expenses.

 

Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased 7% to $28.7 million for the year ended December 31, 2013 compared with $27.0 million in the prior year.  The increase was primarily due to higher distribution costs as a result of the higher sales volumes.

 

Other Operating Expense, Net.  KUPI recorded other operating expense during the year ended December 31, 2013 totaling $278 thousand compared to other operating income totaling $752 thousand in the prior year.

 

Provision for Income Taxes.  KUPI recorded income tax expense for the year ended December 31, 2013 of $21.0 million compared to $16.5 million for the year ended December 31, 2012.  The effective tax rate for the year ended December 31, 2013 was 20%, compared to 20% for the prior year.  The slight increase in the effective tax rate in the year ended December 31, 2013 as compared to the year ended December 31, 2012 was due to the reduced rate benefit associated with reversals of uncertain tax positions upon statutory expirations.

 

At December 31, 2013, KUPI had recognized a net deferred tax asset of $49.2 million.  KUPI has not recorded a valuation allowance against its deferred tax assets given it expects the net deferred tax assets to be fully realizable based on KUPI’s history of profitability and future expectations of taxable income.

 

Net Income.  For the year ended December 31, 2013, KUPI reported net income of $81.6 million.  Comparatively, net income in the prior year was $66.7 million.

 

Liquidity and Capital Resources

 

Historically, UCB has provided KUPI with financing, cash management and other treasury services.  KUPI’s cash balances are swept daily by UCB and historically, KUPI has received funding from UCB for most of its operating and investing cash needs, in the form of short-term loans. Cash transferred to and from UCB has historically been recorded as intercompany receivables and payables.  Following the Acquisition, KUPI’s cash management and financing functions for its operations will be integrated with those of Lannett and KUPI’s primary sources of liquidity will be cash on hand provided from operating activities and financing provided by Lannett.

 

At June 30, 2015, KUPI’s cash position was $1.2 million and working capital was $253.6 million as compared to $295.9 million at December 31, 2014, a decrease of $42.3 million.  Current product portfolio sales as well as sales related to future product approvals are anticipated to continue to generate positive cash flow from operations.

 

Cash Flows

 

 

 

Six Months Ended

 

Year Ended

 

(in thousands)

 

June 30,
2015

 

June 30,
2014

 

December
31, 2014

 

December
31, 2013

 

December
31, 2012

 

 

 

(unaudited)

 

(audited)

 

Net cash provided by (used in):

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

$

77,297

 

$

73,702

 

$

131,893

 

$

(30,187

)

$

6,436

 

Investing activities

 

$

(7,990

)

$

(10,536

)

$

(17,819

)

$

(26,625

)

$

(13,476

)

Financing activities

 

$

(68,232

)

$

(62,336

)

$

(114,366

)

$

57,067

 

$

7,121

 

Net increase (decrease) in cash and cash equivalents

 

$

1,075

 

$

830

 

$

(292

)

$

255

 

$

81

 

 



 

Operating Activities

 

Net cash provided by operating activities of $77.3 million for the six months ended June 30, 2015 reflected net income of $28.5 million, adjustments for non-cash items of $31.2 million, as well as cash provided by changes in operating assets and liabilities of $17.6 million.  In comparison, net cash from operating activities of $73.7 million for the six months ended June 30, 2014 reflected net income of $61.2 million, adjustments for non-cash items of $10.3 million, as well as cash provided by changes in operating assets and liabilities of $2.2 million. Net cash from operating activities of $131.9 million for the year ended December 31, 2014 reflected net income of $118.1 million after adjustments for non-cash items of $10.3 million and cash provided by changes in operating assets and liabilities of $3.5 million.  In comparison, net cash used in operating activities of $30.2 million for the year ended December 31, 2013 reflected net income of $81.6 million after adjustments for non-cash items of $18.8 million and cash used in changes in operating assets and liabilities of $130.6 million.

 

Significant changes in operating assets and liabilities from December 31, 2014 to June 30, 2015 were comprised of:

 

·                  A decrease in accounts receivable of $34.4 million mainly due to the lower net sales, primarily related to Methylphenidate ER and timing of receipts.

·                  A decrease in accounts payable and accrued expenses totaling $14.4 million.  The decrease was primarily the result of timing of payments and expenses related to compensation and benefits as well as sales penalties.

·                  A decrease in liabilities for unrecognized tax benefits totaling $3.3 million primarily related to a current year movement in KUPI’s uncertain tax position pertaining to a temporary reserve.

 

Significant changes in operating assets and liabilities from December 31, 2013 to December 31, 2014 were comprised of:

 

·                  A decrease in accounts receivable of $34.0 million mainly due to the launch of Methylphenidate ER in July 2013 and the timing of receipts.

·                  An increase in inventories of $20.2 million primarily related to normalized seasonal demand and strategic inventory builds.

 

Significant changes in operating assets and liabilities from December 31, 2012 to December 31, 2013 are comprised of:

 

·                  An increase in accounts receivable of $111.5 million, mainly due to the launch of Methylphenidate ER and the timing of receipts.

·                  A decrease in liabilities for unrecognized tax benefits totaling $19.0 million, mainly resulting from the reversals of uncertain tax positions upon statutory expirations.

·                  An increase in accounts payable and accrued expenses of $10.7 million, mainly due to the timing of capital expenditures and higher accrued compensation and benefits.

 

Investing Activities

 

Net cash used in investing activities of $8.0 million for the six months ended June 30, 2015 was mainly the result of purchases of property, plant and equipment of $6.4 million as well as purchases of intangible assets of $1.6 million.  Net cash used in investing activities of $10.5 million for the six months ended June 30, 2014 was primarily related to purchases of property, plant and equipment of $7.3 million and purchases of intangible assets of $3.2 million. Net cash used in investing activities of $17.8 million for the year ended December 31, 2014 was mainly the result of purchases of property, plant and equipment of $13.9 million as well as purchases of intangible assets of $4.1 million.  Net cash used in investing activities of $26.6 million for the year ended December 31, 2013 is mainly the result of purchases of property, plant and equipment of $26.0 million as well as purchases of intangible assets of $1.1 million. Net cash used in investing activities of $13.5 million for the year ended December 31, 2012 is

 



 

mainly due to purchases of property, plant and equipment of $9.0 million as well as purchases of intangible assets of $4.5 million.

 

Financing Activities

 

Net cash used in financing activities of $68.2 million for the six months ended June 30, 2015 was due to increases in the receivables due from UCB.  Net cash used in financing activities of $62.3 million for the six months ended June 30, 2014 was due to increases in the receivables due from UCB. Net cash used in financing activities of $114.4 million for the year ended December 31, 2014 was due to an increase in the receivables due from UCB.  Net cash provided by financing activities of $57.1 million for the year ended December 31, 2013 was due to an increase in the payables due from UCB. Net cash provided by financing activities of $7.1 million for the year ended December 31, 2012 was due to an increase in the payables due to UCB of $62.2 million, partially offset by dividends paid of $55.1 million.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2015, KUPI had no off-balance sheet arrangements that currently have or are reasonably likely to have a material effect on the consolidated financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Contractual Obligations

 

The following table represents annual contractual obligations as of December 31, 2014:

 

 

 

 

 

Less than
1

 

 

 

 

 

More than
5

 

(In thousands)

 

Total

 

year

 

1-3 years

 

3-5 years

 

Years

 

Operating Lease Obligations

 

$

2,258

 

$

698

 

$

778

 

$

647

 

$

135

 

 

Research and Development Arrangements

 

In the normal course of business, KUPI has entered into certain research and development and other arrangements.  As part of these arrangements, KUPI has agreed to certain contingent payments which generally become due and payable only upon the achievement of certain developmental, regulatory, commercial and/or other milestones.  In addition, under certain arrangements, KUPI may be required to make royalty payments based on a percentage of future sales, or another metric, for products currently in development in the event that KUPI begins to market and sell the product.  Due to the inherent uncertainty related to these developmental, regulatory, commercial and/or other milestones, it is unclear if KUPI will ever be required to make such payments.  As such, these contingencies are not reflected in the expected cash requirements for Contractual Obligations in the table above.

 

Critical Accounting Policies

 

The preparation of KUPI’s consolidated financial statements in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) requires the use of estimates and assumptions.  A listing of KUPI’s significant accounting policies are detailed in Note 2: “Summary of Significant Accounting Policies” of KUPI’s audited financial statements included elsewhere in this offering memorandum. A subsection of these accounting policies have been identified by KUPI’s management as “Critical Accounting Policies”.  Critical accounting policies are those which require KUPI’s management to make estimates using assumptions that were uncertain at the time the estimate was made and for which the use of different assumptions, which reasonably could have been used, could have a material impact on the financial condition or results of operations.

 

KUPI’s management has identified the following as “Critical Accounting Policies”: Revenue Recognition, Inventories, Income Taxes, and Goodwill and Intangible Assets.

 



 

Revenue Recognition

 

KUPI recognizes revenue for product sales, contract manufacturing and other services when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the seller’s price to the buyer is fixed and determinable, and collectability is reasonably assured.  KUPI records revenue from product sales and contract manufacturing when title and risk of ownership have been transferred to the customer, which is typically upon delivery to the customer.

 

As is customary in the generic pharmaceutical industry, KUPI’s gross product sales are subject to a variety of deductions in arriving at reported net product sales.  When KUPI recognizes revenue from the sale of its products, an estimate of sales returns and allowances is recorded which reduces gross sales.  While some allowances may be paid in cash, they are primarily settled through the issuance of credit memos.  Depending on the expected method of settlement, for balance sheet classification purposes, such amounts are reflected as a reduction of accounts receivable or as accrued liabilities.  These provisions include estimates for chargebacks, rebates, sales returns and other allowances and cash discounts and are estimated based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers.  The estimation process used to determine the sales returns and allowances provision has been applied on a consistent basis and no material adjustments have been necessary to increase or decrease the reserve as a result of a significant change in underlying estimates.  Accruals for provisions are presented in KUPI’s consolidated financial statements as a reduction to gross sales with the corresponding reserve presented as a reduction of accounts receivable or included in accounts payable and accrued expenses.  The reserves presented as a reduction of accounts receivable totaled $86.7 million, $143.1 million and $130.2 million at June 30, 2015, December 31, 2014 and December 31, 2013, respectively.  Accounts payable and accrued expenses at June 30, 2015, December 31, 2014 and December 31, 2013 included $9.0 million, $8.9 million and $8.8 million, respectively, for certain rebate programs, primarily related to Medicare Part D and Medicaid, and certain sales allowances and other adjustments paid to indirect customers.

 



 

The following tables identify the activity and ending balances of each major category of revenue reserve for the six months ended June 30, 2015 and 2014 and for years ended December 31, 2014, 2013 and 2012:

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Sales
Returns and 
Other 
Allowances

 

Cash
Discounts

 

Total

 

Balance at December 31, 2013

 

$

78,466

 

$

38,201

 

$

11,982

 

$

10,418

 

$

139,067

 

Provisions during the period

 

506,892

 

77,708

 

328

 

16,300

 

601,228

 

Settlements during the period

 

(508,125

)

(81,901

)

(2,890

)

(18,003

)

(610,919

)

Balance at June 30, 2014

 

$

77,233

 

$

34,008

 

$

9,420

 

$

8,715

 

$

129,376

 

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Sales
Returns and
Other
Allowances

 

Cash
Discounts

 

Total

 

Balance at December 31, 2014

 

$

96,018

 

$

37,434

 

$

10,396

 

$

8,187

 

$

152,035

 

Provisions during the period

 

348,179

 

104,046

 

3,056

 

12,600

 

467,881

 

Settlements during the period

 

(397,961

)

(107,089

)

(4,594

)

(14,545

)

(524,189

)

Balance at June 30, 2015

 

$

46,236

 

$

34,391

 

$

8,858

 

$

6,242

 

$

95,727

 

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Sales
Returns and
Other
Allowances

 

Cash
Discounts

 

Total

 

Balance at December 31, 2011

 

$

56,346

 

$

29,573

 

$

7,792

 

$

5,708

 

$

99,419

 

Provisions during the period

 

619,911

 

61,522

 

2,960

 

19,358

 

703,751

 

Settlements during the period

 

(625,950

)

(63,128

)

(2,977

)

(16,581

)

(708,636

)

Balance at December 31, 2012

 

50,307

 

27,967

 

7,775

 

8,485

 

94,534

 

Provisions during the period

 

838,760

 

114,269

 

7,698

 

26,160

 

986,887

 

Settlements during the period

 

(810,601

)

(104,035

)

(3,491

)

(24,227

)

(942,354

)

Balance at December 31, 2013

 

78,466

 

38,201

 

11,982

 

10,418

 

139,067

 

Provisions during the period

 

1,057,491

 

153,976

 

4,523

 

32,860

 

1,248,850

 

Settlements during the period

 

(1,039,939

)

(154,743

)

(6,109

)

(35,091

)

(1,235,882

)

Balance at December 31, 2014

 

$

96,018

 

$

37,434

 

$

10,396

 

$

8,187

 

$

152,035

 

 

For the six months ending June 30, 2015 and 2014, as a percentage of gross sales the provision for chargebacks was 55.2% and 62.2%, the provision for rebates was 16.5% and 9.5%, the provision for sales returns and other was 0.5% and 0.0%, and the provision for cash discounts was 2.0% and 2.0%, respectively.  For the years ending December 31, 2014, 2013 and 2012, as a percentage of gross sales the provision for chargebacks was 63.8%, 63.8% and 63.6%, the provision for rebates was 9.3%, 8.7% and 6.3%, the provision for sales returns and other was 0.3%, 0.6% and 0.3%, and the provision for cash discounts was 2.0%, 2.0% and 2.0%, respectively.

 

The decrease in total reserves from June 30, 2014 to June 30, 2015 was mainly due to a decrease in the chargebacks reserve. The decrease resulted primarily from the lower sales of Methylphenidate ER and the reduction in the price charged to wholesalers in the gastrointestinal products group.

 

The increase in total reserves from December 31, 2013 to December 31, 2014 was mainly due to an increase in the chargeback reserves, partially offset by slight decrease in the reserve for rebates, sales returns and other allowances and cash discounts. The increase in the chargeback reserve resulted from increased gross sales to wholesalers mainly related to Methylphenidate ER.

 

Provisions for chargebacks, rebates, returns and other adjustments require varying degrees of subjectivity.  While rebates generally are based on contractual terms and require minimal estimation, chargebacks and returns require management to make more subjective assumptions.  Each major category is discussed in detail below:

 



 

Chargebacks

 

The provision for chargebacks is the most significant sales allowance.  A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to KUPI by a wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays the wholesaler for that product.  KUPI’s chargeback provision and related reserve vary with changes in product mix, changes in customer mix and pricing and changes to estimated wholesaler inventories.  The provision for chargebacks also takes into account an estimate of expected wholesaler sell-through levels on third party indirect contracts at varying contract prices.  KUPI monitors the chargeback accrual monthly through a review of the actual chargebacks paid and inventory reports obtained from KUPI’s largest wholesale customers.  This customer inventory information is used to assess the reasonableness of the estimated liability for future chargeback claims based on historical chargeback and contract rates.  KUPI’s three largest wholesalers represent approximately 98%, 99%, and 99% of KUPI’s chargebacks, respectively, for the years ended December 31, 2014, 2013 and 2012.  KUPI continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.

 

Rebates

 

Rebates include Medicaid rebates based on claims from Medicaid benefit providers and commercial rebates to indirect and direct customers.

 

The provision for Medicaid rebates is based upon historical experience of claims submitted by the various states.  KUPI monitors Medicaid legislative changes to determine the impact such changes will have on KUPI’s provision for Medicaid rebates.  The accrual of Medicaid rebates is based on historical payment rates and is reviewed on a quarterly basis against actual claim data to ensure the liability is fairly stated.

 

Commercial rebates are contractual discounts allowed to third-party customers including, but not limited to, retailers, wholesalers, and distributors.  These discounts are negotiated and differ by customer and by product.  They can be paid based on either unit sales or dollar sales depending upon the terms of the contract.  KUPI validates the provision for rebates monthly based on the individual terms of the customers’ contracted rebate programs.

 

Sales Returns and Other Allowances

 

The provision for sales returns and other allowances includes returns, pricing adjustments, promotional allowances and billback adjustments.

 

As is common in the industry, KUPI maintains a return policy that allows its customers to return product for credit.  In accordance with KUPI’s return goods policy, credit for customer returns of product is generally applied against outstanding accounts receivable.  Product exchanges are not permitted.  Products returned by customers are generally not resalable.  KUPI’s estimate of the provision for sales returns is based upon historical experience, product expiration dates and current trends of actual customer returns.  Additionally, KUPI considers other factors when estimating its current period sales return provision, including levels of customer inventories as well as significant market changes which may impact future expected sales returns, and makes adjustments to its current period provision for sales returns when it appears product returns may differ from its original estimates.

 

Pricing adjustments include shelf stock adjustments and are credits issued for decreases in selling prices charged to KUPI’s direct customers.  Shelf stock adjustments are based upon the amount of product KUPI’s customers have in their inventory at the time of an agreed-upon price reduction.  KUPI regularly monitors all price changes to help evaluate its reserve balances.  The adequacy of these reserves is readily determinable as pricing adjustments and shelf stock adjustments are negotiated and settled on a customer-by-customer basis.

 

Billback adjustments are credits that are issued to certain customers who purchase directly from KUPI at agreed upon prices as well as indirectly through a wholesaler at a different price.  These credits are issued for the difference between the customer’s direct and indirect contract price.  The provision for billbacks is

 



 

estimated based upon historical purchasing patterns of qualified customers who purchase product directly from KUPI and supplement their purchases indirectly through KUPI’s wholesale customers.

 

Promotional allowances are credits, issued in connection with a product launch or as an incentive for customers to begin carrying a product.  KUPI establishes a reserve for promotional allowances based upon these contractual terms.

 

Cash Discounts

 

Cash discounts are provided to customers that pay outstanding invoices within a specific period.  The provision for discounts is recorded at the time of sale.  Customer payment experience is fairly consistent and substantially all customer payments qualify for the cash discount.

 

Inventories

 

Inventory consists of finished goods held for sale, raw materials, work in process, semi-finished goods, pre-launch products and goods purchased for resale.  Pre-launch products include pharmaceutical products that management believes have a high probability of receiving regulatory approval or products that have already received regulatory approval and are awaiting a contractual triggering event before entering the marketplace.  Costs included in inventory include raw materials, direct and indirect labor, employee benefits, depreciation, general manufacturing overhead and various other costs of manufacturing.  Inventories are stated at the lower of cost or estimated realizable value and are primarily based on standard cost which approximates the first-in, first-out (“FIFO”) or average cost methods.  KUPI recognizes a charge to cost of goods sold for the amount required to reduce the carrying value of inventory to estimated net realizable value.  Provisions for potentially obsolete or slow-moving inventory, including pre-launch inventory, are made based on the analysis of inventory levels, historical obsolescence and future sales forecasts.  If actual conditions are less favorable than estimated, additional charges may be required.

 

Income Taxes

 

KUPI has been included in the UCB consolidated U.S. federal income tax return and certain consolidated state income tax returns.  KUPI also files numerous separate income tax returns in the U.S.  For the purposes of its consolidated financial statements, KUPI has determined its U.S. federal and state income tax provisions as if it were filing separate tax returns.  Given KUPI migrated management and control of its non U.S. subsidiary, KUDCO, to the United States on January 1, 2014, no foreign income taxes are reported for the year ended December 31, 2014.

 

Accrued U.S. federal, state and foreign current income tax balances, including interest, are treated as being settled without payment as of the end of each year by UCB.  Therefore, the settlement of the current income tax liability without payment is treated as a contribution from UCB and is included in payable to (receivable from) Parent in KUPI’s consolidated statements of stockholder’s equity.  Cash income taxes paid in the consolidated statements of cash flows consists of the current federal provision settled through payable to (receivable from) Parent and actual cash payments to states and foreign governments for income taxes.

 

Deferred income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income in the period that includes the enactment date of the rate change.  KUPI records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized.  KUPI has considered future taxable income and ongoing feasible tax planning strategies in assessing the need for a valuation allowance.  KUPI also records uncertain tax positions using a two-step process: (1) it determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, it recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.

 



 

Goodwill and Intangible Assets, Net

 

Goodwill represents costs in excess of fair values assigned to the underlying net assets of acquired businesses.  KUPI tests goodwill for impairment on an annual basis each December by comparing the fair value of KUPI’s single reporting unit to the respective carrying value of the reporting unit.  Additionally, KUPI performs impairment testing on goodwill and intangible assets when events occur that could potentially reduce the fair value of a reporting unit or related assets below their carrying amounts.  The carrying value of the reporting unit is determined by assigning the assets and liabilities, including the existing goodwill and intangible assets, to the reporting unit.

 

Goodwill is considered impaired if the carrying amount of the net assets exceeds the fair value of the reporting unit.  Impairment, if any, could result in a material reduction in net income.  No impairment associated with goodwill was recognized for the six months ended June 30, 2015 and 2014 or for the years ended December 31 2014, 2013 or 2012.

 

Intangible assets are stated at cost if acquired separately or at estimated fair value based on third-party appraisals if acquired as part of a business combination.  Intangible assets are amortized over the estimated useful lives ranging from 2 to 18 years.  No significant residual values are estimated for the amortizable intangible assets.  KUPI recorded amortization either based on the estimated pattern in which the asset’s economic benefits are consumed or on a straight line basis if the pattern of consumption closely approximates straight line.  KUPI periodically reviews the original estimated useful lives of intangible assets and makes adjustments when circumstances and events indicate that a shorter life is appropriate if its asset is impaired.

 

Recent Accounting Pronouncements

 

In July 2013, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2013-10, “Inclusion of the Fed Funds Effective Swap Rate (or Overnight Index Swap Rate) as a Benchmark Interest Rate for Hedge Accounting Purposes” (“ASU 2013-10”). ASU 2013-10 allows the Federal Funds Effective Swap Rate (also referred to as the Overnight Index Swap rate in the U.S.) to be designated as a benchmark interest rate for hedge accounting purposes. The amendments also remove the restriction on using different benchmark rates for similar hedges. ASU 2013-10 is effective prospectively for qualifying new or redesignated hedging relationships entered into on or after July 17, 2013. KUPI has no hedging instruments therefore the adoption of ASU 2013-10 had no impact on KUPI’s consolidated financial position, results of operations or cash flows.

 

Accounting Standards Issued But Not Yet Effective

 

In February 2013, the FASB issued ASU 2013-04, “Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date” (“ASU 2013-04”). ASU 2013-04 provides guidance for the recognition, measurement and disclosure of obligations resulting from joint and several liability arrangements for which the total amount of the obligation within the scope of ASU 2013-04 is fixed at the reporting date. The guidance requires an entity to measure those obligations as the sum of the amount the reporting entity agreed to pay on the basis of its arrangement among its co-obligors as well as any additional amount the reporting entity expects to pay on behalf of its co-obligors. ASU 2013-04 also requires an entity to disclose the nature and amount of those obligations. ASU 2013-04 is effective for reporting periods beginning after December 15, 2014, with early adoption permitted. Retrospective application is required. The adoption of this standard is not expected to have a material impact on KUPI’s consolidated financial position, results of operations or cash flows.

 

In February 2013, the FASB issued ASU 2013-02, “Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income” (“ASU 2013-02”). ASU 2013-02 requires an entity to present, either on the face of the financial statements or in the notes, the effects of significant amounts reclassified out of accumulated other comprehensive income on the respective line items of the consolidated statements of operations and to cross-reference to other required disclosures, where applicable. ASU 2013-02 is effective prospectively for reporting periods beginning after December 15, 2013, with early adoption permitted. The adoption of this standard did not have a material impact on KUPI’s consolidated financial position, results of operations or cash flows.

 



 

In March 2013, the FASB issued ASU 2013-05, “Parent’s Accounting for the Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or Groups of Assets within a Foreign Entity or of an Investment in a Foreign Entity” (“ASU 2013-05”). ASU 2013-05 clarifies the applicable guidance for the release of cumulative translation adjustments into net income when a reporting entity either sells a part or all of its investment in a foreign entity or ceases to have a controlling financial interest in a subsidiary or group of tax benefit, or a portion of an unrecognized tax benefit, to be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, similar tax loss, or a tax credit carryforward. ASU 2013-11 is effective prospectively for reporting periods beginning after December 15, 2014, with early adoption permitted. Retrospective application is permitted. The adoption of this standard is not expected to have a material impact on KUPI’s consolidated financial position, results of operations or cash flows.

 

In May 2014, the FASB issued ASU 2014-09-“Revenue from Contracts with Customers”, which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. KUPI is evaluating its existing revenue recognition policies to determine whether any contracts in the scope of the guidance will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The new standard is effective beginning the first quarter of KUPI’s 2019 year, since KUPI is privately owned. Early adoption is permitted beginning in the first quarter of KUPI’s 2018 year. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. Management is currently evaluating the standard and its impacts on KUPI.

 

In June 2014, the FASB issued ASU No. 2014-12, “Compensation — Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period”, (“ASU 2014-12”). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. ASU 2014- 12 is effective prospectively for reporting periods beginning after December 15, 2015, with early adoption permitted. KUPI does not anticipate that the adoption of this standard will have a material impact on its financial statements.

 


EX-99.3 4 a15-21025_1ex99d3.htm EX-99.3

Exhibit 99.3

 

Lannett

 

(dollars in thousands)

 

Lannett
Historical
Twelve
months

 

Lannett
Historical
Twelve
months

 

Lannett
Historical
Twelve
months

 

Lannett
Historical
Twelve
months

 

Last Twelve
Months Generic
Market Share per
IMS

 

Last Twelve Months
Generic Market
Position per IMS

 

 

 

 

 

 

Products

 

6/30/2012

 

6/30/2013

 

6/30/2014

 

6/30/2015

 

8/31/2015

 

8/31/2015

 

 

 

 

 

 

Levothyroxine

 

$

50,849

 

$

57,978

 

$

102,248

 

$

153,460

 

26

%

2

 

 

 

 

 

 

Ursodiol

 

5,991

 

6,114

 

6,578

 

65,262

 

19

%

3

 

 

 

 

 

 

Digoxin

 

10,895

 

11,669

 

54,721

 

48,959

 

40

%

1

 

 

 

 

 

 

Cocaine Topical

 

10,018

 

14,594

 

21,615

 

22,704

 

100

%

N/A

 

 

 

 

 

 

Acetazolamide

 

4,252

 

6,410

 

11,987

 

21,145

 

44

%

2

 

 

 

 

 

 

Other Products

 

40,985

 

54,290

 

76,621

 

95,307

 

 

 

 

 

 

 

 

 

 

Total net sales

 

$

122,990

 

$

151,054

 

$

273,771

 

$

406,837

 

 

 

 

 

 

 

 

 

 

 

KUPI

 

(dollars in thousands)

 

KUPI
Historical
Twelve
months

 

KUPI
Historical
Twelve
months

 

KUPI
Historical
Twelve
months

 

KUPI
Historical Six
months

 

KUPI Historical Six
months

 

KUPI Historical Last
Twelve Months

 

Last Twelve Months
Generic Market Share
per IMS

 

Last Twelve Months
Generic Market
Position per IMS

 

Products

 

12/31/2012

 

12/31/2013

 

12/31/2014

 

6/30/2014

 

6/30/2015

 

6/30/2015

 

8/31/2015

 

8/31/2015

 

Methylphenidate ER

 

 

59,251

 

151,034

 

83,319

 

36,539

 

104,254

 

17

%

3

 

Omeprazole

 

99,157

 

71,612

 

60,905

 

30,130

 

28,367

 

59,143

 

20

%

2

 

Oxybutynin

 

39,594

 

39,180

 

37,361

 

19,087

 

19,203

 

37,477

 

43

%

2

 

Tussionex

 

36,932

 

38,820

 

31,396

 

18,544

 

11,184

 

24,036

 

51

%

1

 

Nifedipine

 

27,041

 

22,782

 

20,919

 

10,161

 

8,096

 

18,853

 

16

%

2

 

Metadate

 

10,275

 

25,823

 

19,463

 

11,399

 

12,067

 

20,131

 

53

%

1

 

Pantoprazole

 

11,043

 

12,744

 

19,547

 

8,729

 

11,429

 

22,247

 

13

%

3

 

Other Products

 

48,730

 

60,234

 

70,472

 

32,933

 

36,484

 

74,024

 

 

 

 

 

Total net sales

 

$

272,772

 

$

330,446

 

$

411,097

 

$

214,301

 

$

163,369

 

$

360,165

 

 

 

 

 

Net sales to related party

 

9,609

 

10,714

 

18,841

 

10,983

 

12,316

 

20,174

 

 

 

 

 

Contract manufacturing revenue

 

37,698

 

35,673

 

33,082

 

16,589

 

15,849

 

32,342

 

 

 

 

 

Total net revenues

 

$

320,079

 

$

376,833

 

$

463,020

 

$

241,873

 

$

191,534

 

$

412,681