8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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)

February 28, 2013

OPTIMER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-33291	33-0830300
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

101 Hudson Street, Suite 3501

Jersey City, NJ 07302

(Address of principal executive offices, including zip code)

(201) 333-8819

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

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):

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

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

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

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

Item 2.02.     Results of Operations and Financial Condition.

On February 28, 2013, we issued a press release reporting our financial results for the quarter and full year ended December 31, 2012.  A copy of this press release is attached hereto as Exhibit 99.1.  In addition, a copy of the script for the conference call we hosted on February 28, 2013 at 5:00 p.m. Eastern time to discuss our financial results and provide a corporate update is attached hereto as Exhibit 99.2.

Except for the information in Exhibit 99.2 referenced below under Item 8.01, “Other Events”, the information herein and in the exhibits hereto is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01.     Other Events.

The disclosure in our Q4 and Fiscal Year 2012 Optimer Pharmaceuticals Earnings Conference Call Script (attached hereto as Exhibit 99.2) providing an overview of the status of our internal investigation shall be deemed to be “filed” for purposes of Section 18 of the Exchange Act.

Item 9.01      Financial Statements and Exhibits.

(d)  Exhibits.

Exhibit No.	Description
99.1	Press Release dated February 28, 2013.
99.2	Q4 and Fiscal Year 2012 Optimer Pharmaceuticals Earnings Conference Call Script.

2

SIGNATURES

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.

	OPTIMER PHARMACEUTICALS, INC.
By:	/s/ Stephen W. Webster
	Stephen W. Webster
	Chief Financial Officer (Duly Authorized Officer and
	Principal Financial and Accounting Officer)

Date:  February 28, 2013

3

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated February 28, 2013.
99.2	Q4 and Fiscal Year 2012 Optimer Pharmaceuticals Earnings Conference Call Script.

4

EX-99.1

Exhibit 99.1

Optimer Reports Fourth Quarter and Fiscal Year 2012 Financial Results

Optimer reports $62.4 million in DIFICID® (fidaxomicin) tablets net product sales for 2012

JERSEY CITY, New Jersey, February 28, 2013 — Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today unaudited financial results for the fourth quarter and fiscal year ended December 31, 2012.

Financial Highlights

·2012 DIFICID net product sales in the U.S. and Canada of $62.4 million, compared to $21.5 million in 2011

·A 14.3% increase in U.S. and Canadian DIFICID shipments in the fourth quarter, resulting in net sales of $16.8 million

·2012 contract revenue from collaborations, which include up-front payments, milestones, royalties and product sales, were $39.1 million

·2012 total revenues were $101.5 million

·Cash, cash equivalents and short-term investments at December 31, 2012 totaled $124.0 million

·2012 net loss was $37.0 million, or $0.78 per share, and 2012 net income for the fourth quarter was $1.0 million, $0.02 per share

“2012 was an exciting year for Optimer.  DIFICID is now available in over a dozen countries,” said Dr. Henry McKinnell, Optimer’s CEO and Chairman of the Board.  “In the U.S. we will be focusing on improving the formulary status of DIFICID in the hospital marketplace and on expanding the use of this important new medicine in all channels.”

Financial Overview

Total revenue for the years ended December 31, 2012 and 2011 was $101.5 million and $145.0 million, respectively.  Total revenue for the fourth quarter 2012 and 2011 was $19.5 million and $64.6 million, respectively.  The decreases were due to a reduction in contract revenue, which in 2011 included $122.7 million from the Astellas Pharma Europe (APEL) agreement, offset by increases in DIFICID net product sales.

DIFICID net product sales in the U.S. and Canada for the year and quarter ended December 31, 2012 were $62.4 million and $16.8 million, respectively.  We recognize product sales of DIFICID upon delivery of product to our wholesalers.  The increase in DIFICID net product sales in 2012 reflects higher demand for DIFICID, as well as a full year of sales.  DIFICID was launched in July 2011.

Contract revenue for the years ended December 31, 2012 and 2011 was $39.1 million and $122.7 million, respectively, a decrease of $83.6 million.  Contract revenue is generated from collaboration partners and includes up-front and milestone payments, royalties and product sales.  In 2011, contract revenue included a $69.2 million up-front payment from APEL and a $53.5 million milestone upon EMA approval of DIFICLIR™.  Contract revenue in 2012 included a $19.9 million up-front payment from Astellas Japan and a $12.6 million milestone payment from APEL in association with the first commercial sale of DIFICLIR in an APEL territory.  Contract revenues in 2012 also included inventory shipments to our collaboration partners and royalty income from APEL.

Research and development expense for the years ended December 31, 2012 and 2011 was $45.2 million and $43.1 million, respectively, an increase of $2.1 million.  The increase primarily was due to higher health economics and outcomes research and pharmacovigilance expenses.  We also incurred expenses related to our prophylaxis and pediatric clinical trials, which began in 2012.  The increase was partially offset by lower materials costs associated with DIFICID production prior to FDA approval in 2011.  Research and development expense for the quarters ending December 31, 2012 and 2011 was $11.9 million and $14.0 million, respectively, a decrease of $2.1 million.

Selling, general and administrative expense for years ended December 31, 2012 and 2011 was $112.0 million and $80.6 million, respectively, an increase of $31.4 million.  The increase primarily was due to our commercialization efforts for DIFICID which included a full year of expense in 2012.  We also incurred higher compensation expense and higher legal and facilities expenses.  SG&A expense for the quarters ending December 31, 2012 and 2011 was $31.2 million and $30.0 respectively, an increase of $1.2 million. In order to conform to our current period financial statement presentation, we reclassified two line items on our 2011 Consolidated Statements of Operations to separately identify co-promotion expenses with Cubist Pharmaceuticals, Inc.  Previously, Cubist co-promotion expenses were included in our SG&A expense.

Co-promotion expenses with Cubist for the years ended December 31, 2012 and 2011 were $23.2 million and $6.6 million, respectively, an increase of $16.6 million.  This increase was due to a full year of co-promotion expenses and included the year-one sales target bonus and gross profit share on sales above the target.  Co-promotion expenses for the quarters ending December 31, 2012 and 2011 were $3.8 million and $3.6 million, respectively, an increase of $0.2 million.

For the year ended December 31, 2012, Optimer reported a net loss of $37.0 million, or $0.78 per share, on both a basic and diluted basis, as compared to net income for the year ended December 31, 2011 of $7.8 million, or $0.17 per share, on both a basic and diluted basis.  Net income for the fourth quarter of 2012 was $1.0 million, or $0.02 per share, on a basic and diluted basis, as compared to net income for the fourth quarter of 2011 of $13.4 million, or $0.29 and $0.28 per share, on a basic and diluted basis, respectively. Net income in the fourth quarter of 2012 includes a gain of $31.5 million from the sale of our equity interest in Optimer Biotechnology, Inc. (OBI).

At December 31, 2012, Optimer held cash, cash equivalents and short-term investments of $124.0 million.  This includes proceeds from the sale of our equity interest in OBI, which was completed in the fourth quarter.

Optimer had 47.8 million shares outstanding on December 31, 2012.

“Healthcare policy is shifting to new ways to control healthcare spending, particularly in hospitals.  Many of our recent research initiatives, such as analyzing the cost burden of Clostridium difficile infection, are designed to assist hospitals to better understand the disease burden on their patients and institutions,” said Dr. McKinnell.

As of December 31, 2012:

·Inventory levels at wholesalers remain within the range of 14 to 28 days of demand

·Approximately 2,750 hospitals had ordered DIFICID

·About 83% of hospitals covered by Optimer have reordered DIFICID

·Approximately 1,000 hospitals are estimated to have placed DIFICID on formulary

As a result of the management changes announced yesterday and processes and procedures in connection therewith, we have determined that the filing of our Form 10-K will be delayed.”

Conference Call and Webcast

The Company will host a conference call and webcast to discuss its fourth quarter and fiscal year 2012 financial results and provide a corporate update today at 5:00 p.m. Eastern time (2:00 p.m. Pacific time).

The conference call may be accessed by dialing (877) 280-7280 for domestic callers and +1 (678) 825-8232 for international callers.  Please specify to the operator that you would like to join “Optimer’s Financial Results Call.”  The conference call will be webcast live under the Investors section of Optimer’s website at www.optimerpharma.com, where it will be archived for 30 days following the call.

About DIFICID® (fidaxomicin) Tablets

DIFICID is the first macrolide antibacterial drug indicated for Clostridium difficile-associated diarrhea (CDAD) to be approved in over 25 years in the U.S.  It is indicated in the U.S. for the treatment of CDAD in adults 18 years of age or older.  DIFICID is administered in 200 milligram tablets given orally, twice daily.

Important Safety Information for DIFICID

DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or to any of the excipients in the formulation.  DIFICID should not be used for systemic infections.  Only use DIFICID for infection proven, or strongly suspected, to be caused by C. difficile.  Prescribing DIFICID in the absence of a proven, or strongly suspected, C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.  The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).

Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society.  Optimer developed DIFICID® (fidaxomicin) tablets, an FDA-approved macrolide antibacterial drug for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older, and is commercializing DIFICID in the U.S. and Canada.  Optimer also received marketing authorization for fidaxomicin tablets in the European Union where its partner, Astellas Pharma Europe, is commercializing fidaxomicin under the trade name DIFICLIR™.  The Company is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem. Additional information can be found at http://www.optimerpharma.com.

Forward-looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including, without limitation, statements related to the implementation and impact of Optimer’s commercialization strategy, Optimer’s pursuit of new indications for DIFICID, Optimer’s on-going education efforts regarding its patient access initiatives and the burden of Clostridium difficile infection and expansion of DIFICID sales or market potential.  Words such as “expect,” “anticipate,” “will,” “could,” “would,” “project,” “intend,” “plan,” “believe,” “predict,” “estimate,” “should,” “may,” “potential,” “continue,” “ongoing” or variations of such words and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. These forward-looking statements are based on management’s expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: Optimer’s ability to continue to increase adoption and use of DIFICID, the implementation and success of DIFICID growth initiatives and entry into new markets, whether or not healthcare professionals will prescribe DIFICID, the extent to which DIFICID receives reimbursement coverage from healthcare payors and government agencies, the extent to which DIFICID will be accepted on additional hospital formularies and the timing of hospital formulary decisions, Optimer’s ability to successfully coordinate commercialization efforts with Cubist under its co-promotion agreement, whether Optimer will be able to realize expected benefits under its co-promotion agreement with Cubist and its collaboration agreements with other partners, the possibility of alternative means of preventing or treating CDAD impacting adoption and sales of DIFICID, Optimer’s ability, through its third-party manufacturers and logistics providers, to maintain a sufficient supply of DIFICID to meet demand, the effects of changes in Optimer’s management, the outcome of Optimer’s review of strategic alternatives including a possible sale of the Company, the potential for lawsuits and enforcement proceedings related to the previously disclosed investigations by U.S. authorities and other risks detailed in Optimer’s filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this release, and Optimer undertakes no obligation to update or revise these statements, except as may be required by law.

Contacts

Optimer Pharmaceuticals, Inc.

David Walsey, VP of Investor Relations and Corporate Communications

858-964-3418

Canale Communications

Jason I. Spark, Senior Vice President

(619) 849-6005

Optimer Pharmaceuticals, Inc.

Consolidated Statements of Operations and Comprehensive Loss

	Three Months Ended					Years Ended
	December 31,					December 31,
	2012			2011		2012			2011
	(unaudited)					(unaudited)
Revenues:
Product sales, net	$	16,820,952		$	10,959,217	$	62,417,155		$	21,511,037
Contract revenue	2,694,724			53,584,000		39,112,168			122,749,000
Other	—			73,139		2,106			718,336
Total revenues	19,515,676			64,616,356		101,531,429			144,978,373
Cost and expenses:
Cost of product sales	1,364,656			909,843		5,486,239			1,525,798
Cost of contract revenue	1,652,008			3,310,821		6,462,939			7,584,353
Research and development	11,867,287			14,011,078		45,202,722			43,085,307
Selling, general and administrative	31,201,682			29,991,411		112,025,724			80,574,336
Co-promotion expenses with Cubist	3,750,000			3,641,161		23,190,629			6,569,921
Total operating expenses	49,835,633			51,864,314		192,368,253			139,339,715
Gain (loss) from operations	(30,319,957		)	12,752,042		(90,836,824		)	5,638,658
Gain on de-consolidation of OBI	—			—		23,782,229			—
Gain on sale of OBI shares	31,500,606			—		31,500,606			—
Equity in net loss of OBI	—			—		(1,849,254		)	—
Interest income (loss) and other, net	(179,940		)	63,337		136,269			290,870
Consolidated net gain (loss)	1,000,709			12,815,379		(37,266,974		)	5,929,528
Net loss attributable to non-controlling interest	—			538,892		280,344			1,892,096
Net gain (loss) attributable to Optimer Pharmaceuticals, Inc.	$	1,000,709		$	13,354,271	$	(36,986,630	)	$	7,821,624
Net gain (loss) per share - basic	$	0.02		$	0.29	$	(0.78	)	$	0.17
Net gain (loss) per share - diluted	$	0.02		$	0.28	$	(0.78	)	$	0.17
Weighted average number of shares used to compute net gain (loss) per share - basic	47,742,372			46,668,310		47,331,510			45,622,168
Weighted average number of shares used to compute net gain (loss) per share - diluted	48,244,646			47,527,766		47,331,510			46,369,683

Optimer Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

	December 31,		December 31,
	2012		2011
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	119,444,586	$	31,787,512
Short-term investments	4,556,329		78,791,066
Trade accounts receivable, net	7,119,089		6,563,645
Accounts receivable, other	2,391,071		52,289,290
Inventory	15,061,771		3,947,380
Prepaid expenses and other current assets	3,442,717		3,781,830
Total current assets	152,015,563		177,160,723
Property, equipment and other, net	4,338,720		2,590,715
Long-term investments	820,000		882,000
Deferred tax assets, non-current	890,843		—
Other assets	1,362,196		1,389,734
Total assets	$	159,427,322	$	182,023,172
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	7,166,127	$	9,860,462
Accrued expenses	19,165,362		21,447,544
Deferred revenue	456,250		—
Total current liabilities	26,787,739		31,308,006
Deferred rent	938,520		151,141
Income taxes payable, non-current	890,843		—
Stockholders’ equity	130,810,220		150,564,025
Total liabilities and stockholders’ equity	$	159,427,322	$	182,023,172

EX-99.2

Exhibit 99.2

Q4 and Fiscal Year 2012 Optimer Pharmaceuticals Earnings Conference Call Script

OPERATOR: Ladies and gentlemen, thank you for standing by for Optimer Pharmaceuticals’ conference call. I would like to remind you that this call is being recorded. At this time, I would like to turn the call over to David Walsey, Optimer’s Vice President of Investor Relations and Corporate Communications. Please go ahead.

DAVID WALSEY:

Thank you. Welcome to the Optimer Pharmaceuticals fourth quarter and fiscal year 2012 conference call. With me today from the Company is our Chief Executive Officer and Chairman of the Board of Directors, Hank McKinnell, our Chief Financial Officer, Stephen Webster, and Hemal Shah, our Senior Vice President, Medical Affairs, Healthcare Economics, Quality & Outcomes.

Please note that this conference call will include forward-looking statements regarding future events and the future financial performance of Optimer, the expected impact of Optimer’s recent personnel changes, Optimer’s review of strategic alternatives including a possible sale of the Company, future sales and adoption of DIFICID, including plans and initiatives to facilitate patient access, Optimer’s co-promotion agreement with Cubist Pharmaceuticals, Inc., life-cycle management initiatives and commercial efforts, commercialization of DIFICLIR by Astellas Pharma Europe, Optimer’s plans for additional international commercialization of DIFICID, future financial results and expenses and the expected impact of Optimer’s internal investigation and previously disclosed cooperation with relevant U.S. authorities. Because such statements deal with future events, and are subject to many risks and uncertainties, actual results may differ materially from those projected in the forward-looking statements.

Examples of such risks and uncertainties include risks relating to: Optimer’s ability to continue increase the adoption and use of DIFICID, the implementation and success of DIFICID growth initiatives and entry into new markets, whether or not healthcare professionals will prescribe DIFICID, the extent to which DIFICID receives reimbursement coverage from healthcare payors and government agencies, the extent to which DIFICID will be accepted on additional hospital formularies and the timing of hospital formulary decisions, Optimer’s ability to successfully coordinate commercialization efforts with Cubist under its co-promotion agreement, whether Optimer will be able to realize expected benefits under its co-promotion agreement with Cubist and its collaboration agreements with other partners, the possibility of alternative means of preventing or treating CDAD impacting adoption and sales of DIFICID, Optimer’s ability, through its third-party manufacturers and logistics providers, to maintain a sufficient supply of DIFICID

to meet demand, the effects of changes in Optimer’s management, the outcome of Optimer’s review of strategic alternatives including a possible sale of the Company, the potential for lawsuits and enforcement proceedings related to the previously disclosed investigations by U.S. authorities. For a full discussion of these risks and uncertainties, please review Optimer’s annual report on Forms 10-K and subsequent quarterly reports on Form 10-Q as filed with the US Securities and Exchange Commission.

Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 28, 2013. Optimer undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. This conference call is also being webcast, and will be archived on our website for 30 days after today.

Earlier this afternoon, we released financial results for the fourth quarter and fiscal year ended December 31, 2012. If you have not received this news release, or if you would like to be added to the Company’s distribution list, please visit the investor section of our website at www.OptimerPharma.com.

I would now like to turn the call over to Dr. McKinnell, our CEO and Chairman.

HANK MCKINNELL:

Thank you, David.

The Optimer Board of Directors approved several actions this week based on the additional findings from our ongoing internal investigation and the recommendation of our Independent Directors.  We accepted the resignation of our now former CEO and General Counsel.  The Board announced my appointment as Optimer’s Chief Executive Officer (in addition to my current role as Chairman of the Board).  We also announced the appointment of Meredith Schaum as Optimer’s General Counsel and Chief Compliance Officer.

Further, we announced the Board’s decision to commence a process to explore a full range of strategic alternatives. We have engaged J.P. Morgan and Centerview Partners as our financial advisors to help manage this process. Sullivan and Cromwell has been retained as our legal adviser. We cannot predict or speculate on the outcome of this process, or how long it might last. We will not be able to comment on it further until the process is completed.

In discussion with our analysts and investors after the announcement yesterday, we were asked several questions that I would like to try and address. While I will provide some clarification around these questions, I will be unable to provide new information beyond what appears in the press release and SEC filings, including the information contained in the Current Report being filed today on Form 8-K.

As a result of the management changes announced yesterday and processes and procedures in connection therewith, we have determined that the filing of our Form 10-K will be delayed.  In light of this, we wanted to provide a brief overview of the status of our internal investigation:

·Almost a year ago, we became aware of an attempted grant in September of 2011 to Dr. Michael Chang of 1.5 million technical shares of Optimer Biotechnology, Inc..

·We engaged outside counsel to assist us in an internal review and determined that the grant may have violated certain applicable laws, including the Foreign Corrupt Practices Act.

·We self-reported the results of our preliminary findings to the SEC and the DOJ, which included the grant and certain related matters, including a potentially improper $300,000 payment in July 2011 to a research laboratory involving an individual who was also associated with the OBI share grant, and continued our internal investigation.

·At that time, we terminated our then-Chief Financial Officer and our then Vice-President, Clinical Development.

·We also removed Dr. Michael Chang as the Chairman of our Board, and requested that Dr. Michael Chang resign from the Board, which he has not.

·Since that time, we have continued our internal investigation and cooperated with the SEC and the DOJ.

·This month, our Independent Directors determined that additional remedial action should be taken in light of prior compliance, record keeping and conflict-of-interest issues surrounding the potentially improper payment to the research lab and certain related matters. Yesterday, we announced that our CEO and our General Counsel had resigned at the request of the Independent Directors.

·Over the past year we have revised our compliance policies, strengthened our procedures and implemented training and internal audit procedures to make our compliance and monitoring more comprehensive.

·As the SEC and DOJ investigations are continuing, we will not be able provide any additional information at this time.

In addition to requests for additional information about the pending investigations described above, we have also been asked why consider strategic alternatives now?

We continue to support Optimer’s DIFICID strategy, but with new management having just been appointed, now is the time to explore additional strategic alternatives.

A third question frequently asked was whether or not the departures had to do with execution around the commercialization of DIFICID. As we stated in yesterday’s announcement and above, the management changes were appropriate following the Board’s review of prior compliance, record keeping and conflict-of-interest issues observed during the review, including issues arising from the conduct of Optimer personnel who were the subject of the changes in management and leadership announced in April 2012. We recently released fourth quarter and year-end 2012 financial results, and you can see they were generally in line with expectations. Stephen will go through the details shortly.

While there have been challenges in commercializing DIFICID, I think we understand those challenges and we are addressing them with a series of previously-announced strategic initiatives — which I’ll review shortly in my 2012 overview. The Board supports the strategies we have put in place.  We have the team in place to successfully execute these strategies.

I will now turn to a brief overview of the highlights of 2012 and speak of some of the challenges we addressed.  Then Stephen will discuss our unaudited 2012 financial results, after which I will make some brief closing remarks and then we will take your questions.

·DIFICID net product sales for 2012 were $62.4 million.  Cumulative net product sales since launch were $83.9 million which, we believe, places DIFICID among the top-performing product launches for a hospital-based antibiotic.

·We built a 100-person commercial sales force as well as a medical affairs team and a health economics and outcomes research team

·In August, DIFICID became the first and only oral drug to be granted a New Technology Add-on Payment by the Centers for Medicare & Medicaid Services, or CMS.  The CMS special add-on payment is designed to improve reimbursement to hospitals for utilizing breakthrough medical technologies and is only available to new technologies that are inadequately paid for under the existing MS-DRG (Medical Severity-Diagnosis Related Groups) system; and that represent a substantial clinical improvement over existing treatments.

·We have put substantial efforts into commercializing fidaxomicin globally.

·In June 2012, Optimer Canada launched DIFICID for the treatment of Clostridium difficile infection, or CDI, following regulatory approval by Health Canada.

·In the second quarter, our European partner, Astellas Europe, launched DIFICLIR in several European countries.   As of year-end, Astellas Europe had launched DIFICLIR in approximately 10 countries, including the U.K., Spain and France.

·In March of 2012, we entered into a collaboration with Astellas Pharma Inc., or Astellas Japan, for the commercialization of fidaxomicin in Japan.

·In June of 2012, we entered into a distribution and license agreement with Specialised Therapeutics Australia, or STA, to register and commercialize fidaxomicin in Australia and New Zealand.

·Lastly, in the fourth quarter of 2012, we entered into an exclusive agreement with AstraZeneca to commercialize fidaxomicin in Latin America, including Brazil, Central America, Mexico and the Caribbean.

So as you can see, there has been great global interest and activity in the commercialization of fidaxomicin, and we are fortunate to have established collaborations with some of the strongest pharmaceutical companies in each of the regions that we have partnered.  Aggregate contract revenue from partners totaled $39.1 million in 2012.

Despite these successes in 2012, however, we did see a slowing of DIFICID growth in the US in the third quarter which demanded a re-evaluation of our commercial strategy.

During 2012, we recognized certain barriers to patient access and hurdles to product adoption.  In response, we quickly implemented several initiatives in the fourth quarter to help break down those barriers. These programs include:

·a hospital contracting initiative, or discount, designed to address cost as a barrier to prescribing DIFICID for hospital inpatients,

·DIFICID Rx Assist to facilitate continuity-of-care and reduce prescription abandonment in the retail channel, and

·a co-pay assistance program to help reduce the prescription abandonment rate for commercial patients in the retail setting

While it is still too early to fully quantify the impact of these programs, we have seen evidence that these programs are gaining traction:

·A 15% increase in US DIFICID shipments in the fourth quarter

·A large number of hospital P&T committees are re-reviewing DIFICID’s formulary status

·Awareness of our programs is associated with an increased intent to prescribe by physicians

·DIFICID Rx Assist™ - while still a small component of overall sales - is growing, helping more patients and reducing prescription abandonment rates

Additionally, our data on the CDI burden and hospital re-admission rates in the inpatient Medicare population have been presented to hundreds of hospitals, alerting them to the challenges CDI presents not only nationally, but in their individual institutions and networks.

Now I’ll turn the call over to Stephen Webster to discuss our 2012 financial results.

STEPHEN WEBSTER

Thank you, Hank.

DIFICID net product sales in the U.S. and Canada were $62.4 million and $16.8 million for the year and fourth quarter 2012, respectively. We recognize product sales of DIFICID upon delivery of product to our wholesalers.  Total revenues for 2012 were $101.5 million, compared to $145 million for 2011.  Total revenues for the fourth quarter 2012 were $19.5 million, compared with $64.6 for the fourth quarter 2011.

We recognized $39.1 million in contract revenue in 2012 under our collaborations with Astellas Pharmaceuticals Europe Ltd., Astellas Pharma, Inc., Specialized Therapeutics Australia, Pty. Ltd. and AstraZeneca. Inventory levels at wholesalers remain within the range of 14 to 28 days of demand.

For 2012, Optimer reported a net loss of $37 million, or $0.78 cents per share, on both a basic and diluted basis, as compared to net income for 2011 of $7.8 million, or $0.17 cents per share, on both a basic and diluted basis.  Net income in the fourth quarter of 2012 — which includes a gain of $31.5 million from the sale of our equity interest in Optimer Biotechnology, Inc. — was $1 million, or $0.02 per share, on a basic and diluted basis, as compared to a net income for the fourth quarter of 2011 of $13.4 million, or $0.29 and $0.28 per share on a basic and diluted basis.  Net income in 2011 was favorably impacted by $122.7 million in contract revenue from collaborators.

Research and development expense for 2012 was $45.2 million, compared to $43.1 million for 2011. Research and development expense for the fourth quarter of 2012 was $11.9 million, compared to $14.0 million for the fourth quarter of 2011.

Selling, general and administrative expense for 2012 was $112 million, compared to $80.6 million for 2011. SG&A expense for the fourth quarter of 2012 was $31.2 million, compared to $30 million for the fourth quarter of 2011. The increase was due to a full year of commercialization efforts on DIFICID, as well as increases in the fourth quarter related to the launching of the strategic initiatives that Hank discussed earlier

Co-promotion expenses with Cubist for 2012 were $23.2 million, compared to $6.6 million in 2011. The increase represented certain bonus and profit-sharing provisions earned by Cubist under our April 2011 DIFICID co-promotion agreement.

As of December 31, 2012, Optimer held cash, cash equivalents and short-term investments of $124 million. This includes proceeds from the sale of our stake in Optimer Biotechnology, Inc. (OBI).

We had 47.8 million shares outstanding on December 31, 2012.

I’ll now turn the call back over to Hank.

HANK MCKINNELL

Thank you, Stephen.

Our new organization accomplished a lot in 2012, but as I used to say in a previous company, “You ain’t seen anything yet.”  Doctors around the world as the same questions:  What’s new?  We are dedicated to answering that question.

·In 2012, we initiated a Phase 3b clinical trial evaluating DIFICID for the prophylaxis of Clostridium difficile-associated diarrhea in patients undergoing hematopoietic stem cell transplant, often referred to as bone marrow transplantation.  We believe that that the potential use of DIFICID as a preventative treatment for CDAD has considerable commercial potential.

·Under our obligations and commitments to the FDA, we are evaluating DIFICID in a phase 2 pediatric PK trial and plan to initiate a study in patients suffering from multiple recurrences of CDAD later this year.

·As part of our life cycle strategy, we also are looking into other areas for continued clinical evaluation of DIFICID, including studies to demonstrate superiority in cure for CDI in key patient sub-populations.

With DIFICID we have a powerful product for a disease representing a major problem in hospitals and a healthcare environment with decreasing tolerance for infections.  The CDC stated in 2012 that while most healthcare-associated infections are declining, CDI remains at historically high levels(1). We believe DIFICID — and the Company — are well positioned within the evolving healthcare landscape.

That concludes my formal remarks. I will now turn the call over to the operator for your questions.

OPERATOR: OPEN THE CALL TO QUESTIONS

CLOSING

HANK MCKINNELL:

Thank you for joining us today and I look forward to updating you throughout the year on our progress.

Good bye.

(1)  Centers for Disease Control, Vital Signs, March 2012